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THE LATEST INFO ABOUT PREVENTING PRETERM BIRTH
If you are trying to find current information on preterm birth and bed rest, there’s no need to search the Web endlessly. Keep ’Em Cookin’ stays on top of all the latest news, studies, and statistics and reports them here.
THE FUTURE OF PRETERM BIRTH PREVENTION
By Angela Davids
Today is World Prematurity Day. As the founder of KeepEmCookin.com, there isn’t a day that goes by that I am not fighting to prevent premature birth. I talk about the importance of monitoring cervical length to assess the risk of preterm birth, the success of progesterone supplementation to extend the length of a pregnancy, and the ability of a cerclage to help women make it to term. I share how I have seen first-hand how these interventions, typically in combination with bed rest, have helped high-risk women beat the odds. That is my past and my present. Today, let’s look to the future.
In some ways, the future is already here. There is a tool that allows doctors and midwives to measure cervix length anywhere. CerviLenz is an inexpensive plastic device (essentially a ruler) that can be inserted into the vagina by a trained medical professional to measure the length of the cervix instantly. If the cervix length is prematurely short, a patient can be referred for a transvaginal ultrasound and a plan for preterm birth prevention can be made.
The next step is for OBs and midwives to make cervical length screening the standard of care for all women, and especially for those with a history of preterm birth or preterm labor. CerviLenz can help them do that.
Another innovative tool, though years away from reaching the market, is CervoCheck. Designed by Johns Hopkins biomedical engineering students (now graduates) and Dr. Abimbola Aina-Mumuney, the CervoCheck is a ring made of medical grade biocompatible silicone elastomer. The ring is designed to be compressed and inserted into the vaginal canal at a physician’s office or hospital. Embedded within the ring are sensors designed to pick up electrical signals associated with uterine contractions.
Typically, uterine contractions are monitored through the abdominal wall when a woman comes in to Labor & Delivery reporting preterm labor symptoms. At that point it may be too late to prescribe medications to reduce the risk of preterm birth. This device would pick up on uterine contractions before those contractions are even felt by the patient, creating an opportunity for treatment to begin earlier and to improve the chances of extending the length of the pregnancy. CervoCheck, LLC received $99,718 from the National Institutes of Health in October of this year for commercialization assistance.
An alternative to the surgical cerclage for women with a short cervix is being studied. Cervical pessaries could prove to be a low-cost, non-surgical option. A pessary is a ring that is inserted into the vagina to support the uterus to keep it from extending into the vaginal canal.
A recent study showed that in women at high risk for preterm birth, a simple silicone pessary reduced the rate of birth prior to 34 weeks gestation significantly. In the control group, 27 percent of women delivered prior to 34 weeks. In the pessary group, the percentage of women delivering prior to 34 weeks was 6 percent. The study included pregnant women from 18 to 43 years old with a cervical length of 2.5 cm or less as identified during transvaginal ultrasound scanning at 20 to 23 weeks.
Researchers from the study concluded, “Cervical pessary use could prevent preterm birth in a population of appropriately selected at-risk women previously screened for cervical length assessment at the midtrimester scan."
Measuring the Fetal Adrenal Gland
A team of doctors at the University of Maryland and Yale University are looking to another region of the body, the baby’s body in fact, to look for clues about the risk of preterm birth. Their study showed that measuring the fetal adrenal gland with 2D ultrasound to predict impending preterm birth is as effective as using less available 3D imaging to measure fetal adrenal gland volume. Both are more accurate than the conventional technique of measuring the mother’s cervical length, they say.
“We previously discovered that 3D adrenal gland volume is a very accurate predictor of preterm birth," said Dr. Ozhan Turan, the study’s author. “However most people around the world don't have access to that technology, therefore, we have created measurements that can be done with 2D ultrasound that are very effective to predict preterm birth.”
Dr. Turan says that the University of Maryland Medical Center is currently using fetal gland measurement as an assessment tool, which is part of a larger National Institutes of Health study that will include a total of 2,000 pregnant women who are not showing signs of being at risk for preterm birth. By recognizing which women are at the greatest risk of imminent preterm birth, physicians can be more preemptive with treatment options.
As we learn more and more about the proteins found in our body, pregnant women should expect more blood tests with the potential to assess the risk of preterm birth.
For example, researchers in Sweden have developed a method to predict if pregnant women with preterm contractions will give birth within seven days. The method is based on a blood test that looks at two specific proteins in the woman's blood, combined with results from an ultrasound exam to measure the length of the cervix.
"Statistically, the method can predict with 75 to 80 percent accuracy if a woman will give birth early," said researcher Panagiotis Tsiartas, who is also specialist at the Obstetrical and Gynecological Clinic at Sahlgrenska University Hospital. "We will need to conduct further studies before the method can be used in full, but if the results of these studies are good, the test will hopefully lead to new types of treatments to prevent premature birth and treat the serious complications resulting from it," Tsiartas said.
There is a commercial blood test under development in the U.S. that also measures levels of certain proteins. The test, called ProNid, was shown to identify more than 90 percent of women who went on to have a preterm birth, when tested at 24 and 28 weeks of pregnancy. The samples were collected by the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, and the results of one study in particular were published in May of this year in the American Journal of Obstetrics and Gynecology.
The test can be used even when no symptoms of preterm labor are present. This allows patients and doctors to be proactive in preventing preterm birth, with treatments like progesterone supplementation, tocolytics, and bedrest. A multi-center clinical study called the Proteomic Assessment of Preterm Birth, is underway and recruiting subjects at multiple locations around the U.S. The expected completion date for the study is April 2013.
The future of preterm birth prevention makes me optimistic. Five years ago you wouldn’t have seen women casually chatting online about cervix length, cerclage or multiple options for progesterone supplementation the same way they talk about brands of diapers. In no time we’ll be discussing fetal adrenal glands, blood proteins and cervical devices with a sense of power over our pregnancies, and the goal of preventing preterm birth.
FDA GRANTS FAST-TRACK DESIGNATION FOR PREECLAMPSIA DRUGThe FDA has granted fast-track review for a potential new therapy to treat preeclampsia and eclampsia. The FDA will review the request for drug approval and make a decision within sixty days, based on whether the drug fills an unmet medical need in a serious disease. The drug under review is Digoxin Immune Fab (DIF), developed by Glenveigh Medical.
The drug is already approved for use in cases of digoxin overdose. Digoxin is prescribed to treat heart failure and atrial fibrillation.
As many as 30 sites across the country could be involved in an upcoming study.
“This is a tremendous milestone for our company,” said C. David Adair, M.D., Founder, Chairman, and Chief Scientific Officer of Glenveigh. “As a physician and scientist, I have personally seen the devastation these conditions have caused to both moms and babies. Our program, which includes two successful Phase II studies, offers hope to patients that there will be a treatment for severe preeclampsia in the near future.” Previous studies have shown that the drug protected maternal renal function, reduced maternal edema and lowered the incidence of intraventricular hemorrhage (brain bleeds) in DIF infants.
With a fast-track designation, frequent communication between the FDA and the drug company is encouraged throughout the entire drug development and review process. The goal is for questions and issues to be resolved quickly, leading to earlier drug approval and access by patients.
With a medication to treat preeclampsia, physicians will potentially be less inclined to induce preterm delivery in preeclamptic women. The Preeclampsia Foundation reports that preeclampsia is responsible for 15 percent of preterm births in the United States.
THE U.S. PRETERM BIRTH RATE DROPS AGAINThe March of Dimes released its annual Premature Birth Report Card this week, and the results were mixed. The rate of preterm births in the United States dropped to 11.7 percent in 2011, which is the lowest it has been in a decade. The largest declines in premature birth occurred among babies born at 34 to 36 weeks of pregnancy, and there were other areas of improvement as well. Every racial and ethnic group saw a reduction in preterm birth, and there were fewer preterm babies born at all stages of pregnancy.
But, at 11.7 percent as a country, that is still nearly 1 out of 8 babies born too soon and an overall grade of “C.” According to a global report on prematurity released in May of this year, the United States ranks behind 130 other countries in its ability to prevent preterm birth.
“Despite what many might think, the number of babies born too soon in the United States compares poorly with the rest of the world. Even though its preterm birth rate has declined for the 5th year in a row, the United States still ranks 131st in the world,” wrote Dr. Jennifer Howse in a letter to March of Dimes supporters.
On the report card, four states earned an "A": Vermont, Oregon, New Hampshire and Maine, with preterm birth rates of less than the March of Dimes’ goal of 9.6 percent. Alabama, Louisiana, Mississippi and the U.S. territory of Puerto Rico each earned an “F,” with preterm birth rates of 14.6 percent or higher.
View your state’s results here and click on the map to learn about the contributing factors to preterm birth in your state and the recommendations proposed by the March of Dimes.
You can donate to the March of Dimes by clicking here.
DON'T LET THE FLU SNEAK UP ON YOU: GET THE SHOTBy Alfred Romeo, RN, Pregnancy Risk Line
It is flu season again, but before the thought of a flu shot sends you hiding inside a Halloween costume, try to think past the poke. The Organization of Teratology Information Specialists (OTIS) and its affiliate services across North America recommend that all pregnant and breastfeeding women have the influenza vaccine as early as possible in the season.
The flu vaccine helps protect mothers and newborn infants against the influenza virus. Since it takes a few weeks for the body to build enough antibodies for maximum protection, it’s ideal for women to have the vaccine before pregnancy. However, pregnant women can have the flu vaccine during any trimester. Previous and current studies have not found any increased risk of birth defects or poor outcomes during pregnancy from the vaccine. In fact, the Centers for Disease Control tells us there is a greater risk when pregnant women don't have the vaccine, because that the flu is more likely to cause severe illness in pregnant women than in women who are not pregnant. Pregnant women with the flu also have a greater chance for serious problems for their unborn baby, including miscarriage or preterm birth.
Since infants cannot be vaccinated until they are 6 months old, the best way to protect them from the flu virus is for mothers to have the flu vaccine and pass antibodies to their infants in breast milk. It’s also a good idea to have any other family members, relatives, or visitors vaccinated to help protect Mom and Baby from the flu virus. Pregnant women should have the flu injection, or flu shot, instead of the FluMist® nasal-spray.
Some women are concerned about the different virus strains included in the vaccine. Three different flu virus strains are included in the vaccine when it is made each year. Since it takes several months to make, package, and distribute the vaccine, the manufacturers make educated predictions as to which strains might be going around in the next season. So, sometimes a different strain goes around and the vaccine isn’t as helpful. But, some studies have shown that having the vaccine each year will even provide some protection against strains that are not in the vaccine.
Some women are concerned about the preservative thimerosal. Thimerosal, which contains mercury, is used in a very small amount to keep multi-dose vials fresh. A great deal of research has been done on vaccines and thimerosal and the studies have shown no increase in birth defects or other poor outcomes for pregnant women and children. If women are concerned about thimerosal, they can request a single-dose vaccine without the preservative.
There are a few reasons to avoid the flu vaccine. People who have chicken egg allergies or who have had a severe reaction in the past to the flu vaccine should avoid it. People who are sick with a fever should wait until they get well before they are vaccinated. Also, people with Guillain-Barre syndrome, or a history of the condition, should avoid the vaccine.
Help protect yourself, your children, and other children by having the flu vaccine as soon as possible. To find the vaccine near you or for more information, visit www.flu.gov. It’ll be a far better treat for your health than anything you collect in your goody bag.
Alfred Romeo, RN works at the Pregnancy Risk Line, a partnership between the Utah Department of Health and the University of Utah. Visit the website at http://health.utah.gov/prl/. The Pregnancy Risk Line is an affiliate of the Organization of Teratology Information Specialists (OTIS), a non-profit with affiliates across North America. Utah women with questions or concerns about pregnancy or breastfeeding exposures can call 1-800-822-2229. Outside Utah, please call OTIS at 1-866-626-6847. OTIS is conducting several studies, including vaccine studies for influenza and meningitis. Women who have received these vaccines during their current pregnancy can call OTIS to volunteer to participate in the studies or learn more by visiting www.OTISpregnancy.org.
AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS ISSUES NEW GUIDELINES ON THE PREDICTION AND PREVENTION OF PRETERM BIRTH
This week the American College of Obstetricians and Gynecologists
issued new guidelines on the prediction and prevention of preterm birth,
last updated in October 2001. The document provides recommendations
specifically related to the use of progesterone in the prevention of
preterm birth. It also encourages obstetricians to consider a standard
cervical length check for all pregnant women, due to its ability to
predict the risk of preterm birth even when symptoms are not present.
About the use of progesterone, the document stated:
1) A woman with a singleton gestation and a prior spontaneous preterm singleton birth should be offered progesterone supplementation starting at 16 to 24 weeks of gestation, regardless of transvaginal ultrasound cervical length, to reduce the risk of recurrent spontaneous preterm birth.
2) Vaginal progesterone is recommended as a management option to reduce the risk of preterm birth in asymptomatic women with a singleton gestation without a prior preterm birth with an incidentally identified very short cervical length less than or equal to 20 mm before or at 24 weeks of gestation.
3) Progesterone treatment does not reduce the incidence of preterm birth in women with twin or triplet gestations and, therefore, is not recommended as an intervention to prevent preterm birth in women with multiple gestations.
Regarding standard cervical length testing by vaginal ultrasound, the
American College of Obstetricians and Gynecologists wrote, "Although
this document does not mandate universal cervical length screening in
women without a prior preterm birth, this screening strategy may be
considered. Short cervical length measured by transvaginal
ultrasonography also has been associated with an increased risk of
preterm birth. Short cervical length is most commonly defined as less
than 25 mm, usually before 24 weeks of gestation, but up to 28 weeks of
gestation in some series. It is a cutoff that has been associated with
an increased risk of preterm birth in screened populations. Clinically,
the shorter the cervical length, the greater the risk of preterm birth. "
The document also emphasized the importance of transvaginal ultrasound over abdominal ultrasound when measuring cervix length: "Transvaginal cervical ultrasonography has been shown to be a reliable and reproducible way to assess the length of the cervix. This is in contrast to transabdominal ultrasound evaluation of the cervix. Unlike the transabdominal approach, transvaginal cervical ultrasonography is not affected by maternal obesity, position of the cervix, and shadowing from the fetal presenting part."
Source: ACOG Practice Bulletin #130
POTENTIAL NEW TEST FOR PREDICTING PRETERM BIRTH
Researchers in Sweden have developed a method to predict if pregnant women with preterm contractions will give birth within seven days. The method is based on a blood test that looks at two specific proteins in the woman's blood, combined with results from an ultrasound exam to measure the length of the cervix.
Researchers at the Sahlgrenska Academy, University of Gothenburg studied 142 pregnant women between 22 and 33 weeks of gestation who came to Sahlgrenska University Hospital during the years 1995 to 2005 with early contractions without rupture of the membranes. They took blood samples from the mothers to look at 27 proteins. Levels of each protein were compared, and calculations were performed to look for associations between different proteins, cervical length, and spontaneous preterm delivery.
"Statistically, the method can predict with 75 to 80 percent accuracy if a woman will give birth early," said researcher Panagiotis Tsiartas, who is also specialist at the Obstetrical and Gynecological Clinic at Sahlgrenska University Hospital.
"We will need to conduct further studies before the method can be used in full, but if the results of these studies are good, the test will hopefully lead to new types of treatments to prevent premature birth and treat the serious complications resulting from it," Tsiartas said.
This study was featured in the article "Prediction of spontaneous preterm delivery in women with threatened preterm labour: a prospective cohort study of multiple proteins in maternal serum" in the British Journal of Obstetrics and Gynaecology.
MAKENA TO BE COVERED BY MEDICAID IN GEORGIA
A U.S. district judge in Georgia has ruled that the state’s
Department of Community Health must provide Medicaid coverage for
Makena, rather than continue its current policy of denying claims for
Makena in favor of the compounded version of hydroxyprogesterone
caproate (17P). The Atlanta Journal-Constitution reported today that the
court favored the brand-name synthetic progesterone injection because
it has Food and Drug Administration approval and the compounded drug
State officials argued for the use of the compounded 17P, at about $20 per shot, versus Makena, which drug manufacturer K-V Pharmaceutical makes available to state Medicaid programs for $300 or less per shot.
K-V Pharmaceutical issued a statement July 2, 2012, in which they wrote, "Tens of thousands of pregnant women at high risk for recurrent preterm birth are being denied FDA-approved Makena by certain payers whose coverage policies cite outdated March 2011 statements from FDA and the Center for Medicare and Medicaid Services (CMS). ... Medicaid participants, in particular, have been denied access to the only FDA-approved medication for their condition...".
This judgement comes just days after K-V Pharmaceutical filed for Chapter 11 bankruptcy protection.
MAKENA MANUFACTURER FILES FOR BANKRUPTCY PROTECTION
K-V Pharmaceutical Co. has filed filing for Chapter 11 bankruptcy protection, reported the Associated Press today. K-V said it has been unable to realize the value of Makena because the FDA is not enforcing the marketing exclusivity that was awarded to Makena. The company also owes a milestone payment to Hologic Inc., which developed the drug. It has not been able to renegotiate that payment. K-V said restrictions related to 2008 and 2009 manufacturing problems are also hurting its business.
Makena is intended to prevent preterm birth in women who've already had one premature birth and are pregnant again. The drug is a synthetic version of the hormone progesterone. Makena was approved in February 2011 and costs $690 per weekly injection. That price has been a source of controversy even after K-V lowered the cost from $1,500 per injection and announced a patient assistance program designed to help uninsured and low-income women get the drug at little or no cost.
Specialty pharmacies can make a generic version of progesterone that costs $10 to $20 a dose, which has hurt K-V's sales. After approving Makena, the FDA said it would not stop specialty pharmacies from making the generic version. K-V announced the price cut after the FDA made that decision.
The company continues to operate.
IVF AND THE RACIAL DISPARITIES IN THE RISK OF PRETERM BIRTH
Black women who conceive using in vitro fertilization are at a markedly increased risk of any type of preterm birth, compared with other races, a retrospective cohort study indicates.
Hispanic women had a significantly lower rate of preterm births than did black women, and similar or slightly higher rates than did white women.
Native American women were not at an increased risk of any type of preterm birth, compared with whites, whereas Asians were at a reduced risk of preterm twin births.
"There exist notable racial and ethnic disparities in preterm births in infants conceived by IVF, with the highest rate in black women," Dr. Xu Xiong of the school of public health and tropical medicine at Tulane University in New Orleans reported at the annual meeting of the Society for Pediatric and Perinatal Epidemiologic Research.
Racial disparities in preterm birth may reflect biological differences resulting from genetic background or from variations in social demographics, socioeconomic status (SES), environmental exposures, lifestyles, cultural factors, and access to care and treatment, he said. SES factors (such as income, education, and occupation) were not available in the data set, although all of the women were able to finance expensive and time-consuming IVF treatment.
"In this study of relatively higher income women [who] conceived by IVF, our findings of an even greater difference in preterm births between black and white women than in the general population indicate that SES may not be as solely important a determinant for the racial gaps of preterm birth than previously postulated," Dr. Xiong said in an interview.
The investigators conducted a retrospective cohort study of 56,465 singleton and 23,748 twin pregnancies resulting from fresh nondonor IVF cycles in 82,519 women, using 2006-2008 data from the SART CORS (Society for Assisted Reproductive Technology Clinic Outcome Reporting System).
FDA ISSUES STATEMENT REGARDING THE USE OF MAKENA VERSUS GENERIC 17P
Because of the high cost of Makena, which is a synthetic progesterone approved by the FDA to reduce the risk of preterm birth in women who have experienced a prior preterm birth, many doctors have continued to prescribe the generic form of progesterone that is available through compounding pharmacies. Today the FDA issued a statement to advise physicians regarding this practice and educate the public about the differences between a generic and brand-name drug.
The full document is available here, with a few highlights below that will help guide you in discussions with your doctor.
What is pharmacy compounding?
The FDA regards pharmacy compounding as the combining or altering of the ingredients of a drug by a licensed pharmacist to produce a drug tailored to an individual patient’s particular medical needs, based on a valid prescription from a licensed medical practitioner. For example, compounding may occur if a patient needs a medication to be produced without a dye or preservative due to an allergy, or needs a medication in a liquid or suppository form because the patient cannot swallow a pill.
How will a patient know if she is receiving Makena or a compounded product?
patient can ask her health care provider what product is being
administered. A label will also be visible on the vial or syringe with
information such as the patient name, prescription number, and name of
the product. Typically, if the pharmacy dispenses the FDA-approved
product, it will have the brand name “Makena” on the label.
Click to read more of the FDA's statement.
A SIMPLE SILICONE RING COULD REDUCE THE PRETERM BIRTH RATE
Results from a new study show that cervical pessaries could prove to
be a low-cost, non-surgical option for women at risk of preterm birth
due to a short cervix.
In the first multicenter randomized trial to test the use of a cervical
pessary in women at high risk for preterm birth, a simple silicone ring
reduced the rate of birth prior to 34 weeks gestation significantly. In
the control group, 27% of women delivered prior to 34 weeks. In the
pessary group, the percentage of women delivering prior to 34 weeks was
A pessary is a ring that is inserted into the vagina to support the uterus to keep it from extending into the vaginal canal.
The study included pregnant women from 18—43 years old with a cervical length of 2.5 cm or less as identified during transvaginal ultrasound scanning at 20 to 23 weeks.
Five hospitals in Spain identified 385 pregnant women with a short cervix. A computer program randomly assigned 192 women to have a pessary inserted and 193 women to be treated without the pessary. There were 190 pregnancies analyzed in each group.
Researchers from the Spanish study concluded, “Cervical pessary use could prevent preterm birth in a population of appropriately selected at-risk women previously screened for cervical length assessment at the midtrimester scan." The study results were published today in The Lancet.
WATSON PHARMACEUTICALS NOT GIVING UP ON PRETERM BIRTH PREVENTION DRUG
The Food and Drug Administration has declined approval of progesterone vaginal gel for the prevention of preterm deliveries among women with a short cervical length in the second trimester. The FDA presented its decision in a letter to Watson Pharmaceuticals, stating that the gel (known also as Prochieve) did not meet the level of statistical significance generally expected to support the approval of the product in the U.S. market from a single trial. The FDA also raised the issue of efficacy in the U.S. sub-cohort as compared to the overall efficacy of the trial, and stated that additional clinical work would be required to support the approval.
“We have formally requested an end of review meeting with the FDA to determine if a viable path forward can be established for this application,” said Paul Bisaro, Watson President and CEO, in a statement today.
The New Drug Application (NDA 22-139) was sponsored by Columbia Laboratories until February 10, 2012, when they transferred the application to Watson. All activities and sponsor obligations relating to this application now fall to Watson.
“Watson will work directly with the FDA to address items raised in the
complete response letter regarding the approvability of progesterone vaginal
gel 8% for reduction of preterm birth,” Bisaro said. “We believe that there is
a significant unmet medical need for a safe and effective treatment of patients
at risk for preterm birth which affects approximately one-in-eight live-born
infants in the U.S."
Prochieve is currently used by some obstetricians off-label for women with a short cervix in the second trimester, which can be discovered incidentally during the 20-week ultrasound. FDA approval would allow progesterone gel to be more widely used, due to the greater likelihood that insurers will cover its use for this purpose and through the consumer education about short cervix that would result from advertising the progesterone gel.
ADVISORY COMMITTEE VOTES NOT TO SUPPORT FDA APPROVAL OF PROGESTERONE GEL FOR PRETERM BIRTH PREVENTION
An advisory committee made up of physicians and public health professionals from around the country voted yesterday 13 to 4 not to support FDA approval of progesterone gel for the prevention of preterm deliveries among women with a short cervical length in the second trimester. The ultimate decision will be made by the FDA’s Division of Reproductive and Urologic Products by February 26.
The Advisory Committee of Reproductive Health Drugs appeared to focus on the difference between study results in U.S. and non-U.S study subjects, an argument presented by an FDA reviewer and an an FDA statistician. Based on FDA analysis of the data (adjusted for maternal age and cervical length) study subjects in the U.S. saw a 2.4 percent reduction in preterm births prior to 33 weeks, whereas non-U.S. subjects saw a reduction of 9.7 percent. The cause of the variation was unclear, though there was speculation about the 28 percent noncompliance rate in the U.S. versus 1.6 percent in non-U.S. regions.
The same data, unadjusted, when analyzed by researchers at NIH and
Columbia Laboratories, showed a 44 percent reduction of preterm birth
prior to 33 weeks. That randomized and placebo-controlled study
(referred to as the PREGNANT study, or Study 302 by the FDA) showed
that the progesterone gel was associated with a significant reduction in
the risk of preterm birth before 28 weeks and 35 weeks of gestation as
The Study 302 results reviewed by the FDA were similar to a recent meta-analysis of five studies on the effects of progesterone gel in preventing preterm birth, where it was shown to reduce the rate of preterm birth prior to 33 weeks by 42 percent.
The Advisory Committee members spoke of other reasons against support for the progesterone gel, including concerns that the drug may only work in a small percentage of women in general, that approval may prevent continued research for alternate solutions, and that a higher standard of scrutiny must be held when a drug manufacturer will be given permission to advertise that a drug performs a certain function. Multiple members of the committee recommended an additional study with a larger sample size, based solely in the U.S.
Frank Condella, President and CEO of Columbia Laboratories, said in a statement yesterday, "We will work with the FDA to address the Advisory Committee's comments as the Agency finalizes its review of our NDA. We remain confident in the PREGNANT study results that showed the administration of progesterone vaginal gel 8% is a safe and effective treatment for patients at risk for preterm birth due to short uterine cervical length in the mid-trimester of pregnancy. We hope the agency’s final decision will acknowledge the clear unmet medical need in this patient population.”
Also of note, for those familiar with the Makena pricing controversy, a representative from Watson Pharmaceuticals (who would market the drug) stated at the meeting that, if approved, pricing of the progesterone gel as a preterm birth prevention measure would be comparable to its current price under the brand names Crinone and Prochieve, which have been used for more than 10 years to enhance fertility and encourage regular menstrual cycles. These drugs are currently used by some obstetricians off-label for women with a short cervix in the second trimester, which can be discovered incidentally during the 20-week ultrasound.
FDA approval would allow progesterone gel to be more widely used, due to the greater likelihood that insurers will cover its use for this purpose and through the consumer education about short cervix that would result from advertising the progesterone gel.
The Food and Drug Administration’s Division of Reproductive and Urologic Products can be contacted by calling (301) 796-2130 or writing to: Director Scott Monroe, M.D., 5901-B Ammendale Road, Beltsville, MD 20705-1266.
FDA QUESTIONS EFFICACY OF PROGESTERONE GEL IN U.S. STUDY SUBJECTSThe FDA is scrutinizing the effectiveness of a vaginal progesterone gel for American women at risk of preterm birth. In a document published Tuesday in preparation for a meeting of the Advisory Committee for Reproductive Health Drugs to be held Friday, members of the FDA have said that evidence presented by drug applicant Columbia Laboratories “does not support the efficacy of progesterone gel 8% for the prevention of preterm deliveries among women with a short cervical length.” This is a stark contrast to a meta-analysis published last month in the American Journal of Obstetrics and Gynecology that reported a 42 percent reduction in preterm births prior to 33 weeks when progesterone gel is used. (See article below dated 12-15-11.)
In the new drug application, Columbia Laboratories presented the results of two studies, whereas the meta-analysis mentioned above looked at the results of five studies. One of the studies included in the application was discarded in the FDA review process because only 33 women met the requirement of having a “short cervix,” which the FDA accepts as a cervix measuring less than 2.5 cm in the second trimester. The other women in the study were selected because of a previous delivery prior to 35 weeks.
The second study included in the application was a double-blind, placebo-controlled study that focused on women with a cervical length of 1 to 2 cm between 19 and 24 weeks with a singleton pregnancy. The study was conducted at 23 sites in the United States and 21 sites in nine foreign countries. The risk of preterm birth prior to 33 weeks was reduced by 6.3 percent in the total population of the study. The FDA then separated the results into U.S. and non-U.S sub-groups to discover that the risk was reduced by 2.4 percent in the U.S. test population.
The FDA considers the results in both groups “not statistically significant,” even after adjusting for the following variables: gestational age of previous preterm birth, gestational age at first dose, maternal age, pretreatment cervical length, BMI and race.
The FDA will not make a final decision “until input from the Advisory Committee process has been considered and all reviews have been finalized.” The FDA Advisory Committee meeting to discuss this new drug application of progesterone gel 8% is open to the public. It will be held at the FDA’s Silver Spring, Md., campus this Friday, January 20. The FDA will post details here about a live, free webcast of the meeting.
PUBLIC COMMENTS ENCOURAGED AT FDA MEETING TO REVIEW NEW PRETERM BIRTH PREVENTION DRUGThe Food and Drug Administration is accepting public comments to be presented during a meeting of the Advisory Committee of Reproductive Health Drugs January 20, 2012, during which they will review the new drug application for a vaginal progesterone gel to be used for preventing preterm birth in women with a singleton pregnancy and a short cervix.
The gel, currently marketed as Prochieve and Crinone, is already approved for improving female fertility and increasing the likelihood for the successful implantation of an egg. It is manufactured by Columbia Laboratories and is marketed in the U.S. by Watson Pharmaceuticals.
Written submissions may be made to Kalyani Bhatt (Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993-0002; ACRHD@fda.hhs.gov) on or before January 10, 2012. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify Kalyani Bhatt and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation, on or before January 3, 2012.
The FDA is scheduled to decide by Feb. 26, 2012 on this use of the drug.
PROGESTERONE GEL SHOWN TO REDUCE RATE OF EARLY PRETERM BIRTH BY 42 PERCENTThe use of vaginal progesterone gel in women with a short cervix but no preterm labor symptoms has been shown to reduce the risk of preterm birth prior to 33 weeks by 42 percent, compared to a placebo, according to an article published online yesterday by the American Journal of Obstetrics and Gynecology. There was also a significant reduction in the rate of preterm births before 35, 34, 30 and 28 weeks.
The article was a review and meta-analysis of five randomized controlled clinical trials that included a total of 775 women and 827 infants. The reviewers concluded that “Vaginal progesterone administration to asymptomatic women with a sonographic short cervix reduces the risk of preterm birth and neonatal morbidity and mortality.” The authors of the article recommend standardized cervical length screenings by transvaginal ultrasound for pregnant women between 19 and 24 weeks gestation.
The gel (Prochieve) that was used in the five studies is currently FDA-approved to improve the fertility of some women and increase the likelihood for the successful implantation of an egg. It is manufactured by Columbia Laboratories and is marketed in the U.S. by Watson Pharmaceuticals. Columbia is seeking FDA approval for the use of progesterone gel for preventing preterm birth in women with a singleton pregnancy and a short cervix. The FDA is scheduled to decide by Feb. 26 on this use of the drug, and the FDA’s Advisory Committee for Reproductive Health Drugs will be meeting January 20 to review this new drug application.
THE UNITED STATES EARNS A "C" ON THE MARCH OF DIMES ANNUAL PREMATURE BIRTH REPORT CARDThe rate of preterm birth in the U.S. is higher than most developed nations, with 1 in 8 babies born prematurely. That is 543,000 babies annually. The United States received a “C” based on comparing the nation’s 2009 preliminary preterm birth rate of 12.2 percent with the March of Dimes new 2020 goal of 9.6 percent of all live births.
The March of Dimes reports that there was improvement in the preterm birth rate in almost every state between 2006 and 2009, and in several states the change was more than 10 percent.
The improvement in the preterm birth rate is due to a variety of health interventions, the March of Dimes says. For more than two years, the March of Dimes has been working with hospitals and health policy experts to identify and promote quality improvement initiatives that have reduced the number of medically unnecessary c-sections and inductions scheduled before 39 weeks of pregnancy. Also new treatments, such as progesterone, which has been shown to prevent some preterm births in medically eligible women, has helped lower the preterm birth rate.
Click on the source link below to see how your individual state ranked.
A COMMERCIAL BLOOD TEST TO ASSESS THE RISK OF PRETERM BIRTH IS UNDER DEVELOPMENTInitial studies have shown that a preterm birth prediction test in development by Sera Prognostics Inc. was able to identify more than 90 percent of women who went on to have a preterm birth, when tested at 24 and 28 weeks of pregnancy. The test measures levels of certain proteins that are detectible only when a woman is pregnant. The samples were collected by the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, and the results of one study in particular were published in May in the American Journal of Obstetrics and Gynecology.
It is a simple blood test that can be combined with other standard maternal tests (like diabetes testing), and can be used even when no symptoms of preterm labor are yet present. This allows patients and doctors to be proactive in preventing preterm birth, with treatments like progesterone supplementation, tocolytics, and bedrest.
Sera is conducting a multi-center clinical study called the Proteomic Assessment of Preterm Risk, or PAPR, in hospitals in western, northeast and southern U.S. regions. The study will analyze blood samples taken a various points in each woman’s pregnancy. The results will be used to move this proprietary testing technique into a commercial format that can be approved by the FDA and put into general practice.
PROCHIEVE PROGESTERONE GEL ONE STEP CLOSER TO THE U.S. MARKETColumbia Laboratories submitted a New Drug Application to the U.S. Food and Drug Administration Tuesday for PROCHIEVE, a progesterone gel used to reduce the risk of preterm birth in women with short uterine cervical length in the second trimester of pregnancy.
"Premature cervical shortening is a powerful predictor of risk for preterm delivery. At present, there are no widely accepted interventions to address this medical need," said Frank C. Condella, President and Chief Executive Officer of Columbia Laboratories, Inc. "The recently published PREGNANT study has demonstrated that the use of PROCHIEVE can significantly reduce the incidence of early preterm birth in women with a short cervix at mid-pregnancy and the study also provided evidence of improvement in infant outcome.”
The next step will be notification from the FDA on whether or not the New Drug Application submission has been accepted and if a request for priority review is granted. Columbia requested priority review, which is typically given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. The FDA's goal for completing a priority review is six months, versus ten months for a standard review.
PROCHIEVE will be marketed by Watson Pharmaceuticals. "The combination of cervical screening, together with PROCHIEVE therapy, if approved by the FDA, may result in significant clinical benefits in a population where there are currently no effective therapies," said Fred Wilkinson, Watson's Executive Vice President, Global Brands.
The submission includes data from two Phase III clinical trials evaluating the use of PROCHIEVE in reducing the risk of preterm birth. (Please see the article below dated 4.6.11 for more information on these trials.)
STUDY FINDS THAT 17P DOES NOT REDUCE THE RATE OF PRETERM DELIVERY IN TWINSA placebo-controlled, double-blind clinical trial of 240 mothers in various locations showed that weekly injections of 17-alpha-hydroxyxprogesterone caproate until 34 weeks did not significantly influence gestational age at delivery. In fact, those in the placebo group typically delivered 3 days later than those in the 17P group. Specifically, the 17P group showed a mean gestational age of 35.3 weeks versus the placebo group at 35.9 weeks.
“We chose to study the effects of progesterone on twin pregnancies since that group is at a high risk of preterm delivery and we are always looking for something that will reduce those risks,” said C. Andrew Combs, M.D., one of the study’s authors. About half all of twins are born prior to 37 weeks, according to the American Congress of Obstetricians and Gynecologists.
“We also noted that contrary to our previous study that showed an increased risk of pregnancy loss in triplet pregnancies treated with 17P, we had no deaths in the twins treated with 17P,” said Combs. “However more studies are needed and it is clear that 17P should only be used with specific high risk pregnancy groups.”
In a 2003 study, women with singleton pregnancies received progesterone injections starting sometime between weeks 16 and 21, and continuing until delivery or week 37, whichever came first. Women in the 17P group had 34 percent fewer premature births than women given the placebo, and there was a reduction of 42 percent in the rate of preterm births before 32 weeks.
The twins study was presented at the Society for Maternal-Fetal Medicine’s annual meeting in February and published in the March issue of the American Journal of Obstetrics & Gynecology.
DAILY PROGESTERONE GEL SHOWN TO REDUCE RISK OF EARLY PRETERM BIRTHFor pregnant women with a short cervical length measured by ultrasound from 19 weeks up to 24 weeks, treatment with daily vaginal progesterone gel is associated with a 45 percent reduction in the number of preterm births prior to 33 weeks gestation, according to a study published in the peer-reviewed journal Ultrasound in Obstetrics and Gynecology.
The randomized and placebo-controlled study also showed that the progesterone gel was associated with a significant reduction in the risk of preterm birth before 28 weeks and 35 weeks of gestation as well. There was also a significant reduction in respiratory distress syndrome. Of women in the progesterone group, 6.4 percent delivered babies weighing under 1500 grams, versus 13.6 percent in the placebo group.
Researchers chose women for the study who had no symptoms of preterm labor but were found to have a cervix length of 1.0 cm to 2.0 cm during weeks 19 through 23 weeks/6 days gestation. These women were randomly selected to receive vaginal progesterone gel or a placebo daily until 36 weeks/6 days gestation, a rupture of membranes, or delivery, whichever occurred first.
Dr. Sonia Hassan, the lead author of the report, said in a press release, “Sonographic short cervix is a powerful predictor of preterm delivery. Our data indicate that universal transvaginal screening of women in the midtrimester to identify patients at risk can be coupled with vaginal progesterone to reduce the frequency of preterm birth and improve neonatal outcome. The availability of such clinical option would represent a significant advance in the prevention of early preterm birth and its associated complications.”
The study was funded by Columbia Laboratories, Inc., the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institutes of Health. Columbia Laboratories intends to seek FDA approval for the gel, known in this study as PROCHIEVE, which will be marketed by Watson Pharmaceuticals.
“As demonstrated by the positive results published today, we are convinced that the combination of cervical screening, together with PROCHIEVE therapy, if approved by the FDA, may result in significant clinical benefits and improved infant outcomes, and subsequent savings to the healthcare system,” said Fred Wilkinson, Watson’s Executive Vice President, Global Brands. He continued, "Now, with this important data broadly available for review by the scientific and medical community, we can work to educate health care providers on the benefits of cervical screening and ensure it becomes a standardized component of the prenatal care regimen, ensuring that pregnant women at potential risk are identified."
FDA WILL NOT PREVENT GENERIC COMPOUNDING OF 17PThe FDA says compounding pharmacies are still permitted to produce injections containing hydroxyprogesterone caproate, even though it is the active ingredient in Makena, a drug that received FDA approval and seven years of market exclusivity February 3.
In its statement, the FDA made no mention of the $1500-per-injection price of Makena set by manufacturer K-V Pharmaceutical earlier this month, but the exclusivity created by the high cost appeared to play a role: “In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action” against pharmacists who compound hydroxyprogesterone caproate.
Pharmacists can continue to produce the preterm labor prevention drug as they have for nearly a decade, “unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products,” the FDA said. Compounding pharmacies would not be able to mass produce and market hydroxyprogesterone caproate, also called 17P, but they can provide the injectable solution to any individual patient who has a valid prescription.
Learn more about the benefits of 17P in preventing premature birth.
MARCH OF DIMES SETS GROUND RULES FOR MEETING ON MAKENAMarch of Dimes president Jennifer L. Howse sent a letter March 23 to Ther-RX president Greg Divis, in preparation for a meeting scheduled next week to discuss the $1500-per-injection list price for Makena. The meeting will include representatives from the March of Dimes, the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and the Society for Maternal Fetal Medicine. It said, in part:
"In advance of that meeting, I want to go on the record that March of Dimes expects Ther-Rx to come to the table with substantive commitments including:
1. A significant reduction in the list price of Makena.
2. Adjustments to the patient assistance program to ensure adequate coverage of all patients, insured, uninsured and underinsured.
3. A method for reporting on a regular basis to stakeholders on the patient assistance program to ensure that it is meeting needs in a timely and adequate way.
4. A justification or rationale for your pricing based on your investment in the product, savings to the health care system, or other appropriate methodology, which you are prepared to make public.
Without these elements, I do not believe that Makena can succeed in the current marketplace environment, and as a result, at-risk women will be denied access to a safe and effective treatment to reduce preterm delivery. Therefore if you are unable to make a clear commitment to significantly address the above issues at the meeting, the March of Dimes will need to pursue alternative strategies for ensuring that this proven intervention to prevent preterm birth is made available to all medically eligible pregnant women, and we will step away from our longstanding and productive corporate relationship with Ther-RX."
Click here to read the full letter.
OBs BOYCOTT MAKENA PROGESTERONE INJECTIONSThree obstetricians are leading a boycott against K-V Pharmaceutical and its subsidiary Ther-RX over the cost of 17P injections. What once cost $15 per injection now costs $1500 per injection under the brand name Makena.
“I will not write a single dose of Makena, and I call for you to do the same,” wrote Nicholas Fogelson MD of Columbia, South Carolina, last week on his blog www.academicobgyn.com. “If I can, I will continue to use compounded 17-OHP. If I can’t, I will recommend daily vaginal Prometrium, which very likely will have the same effect as 17-OHP. It’s off label, but so was 17-OHP before K-V got a hold of it. If a patient asks, I will politely explain that I refuse to give in to K-V Pharmaceutical and their piracy.”
Dr. Jennifer Gunter encourages her fellow OBs to continue prescribing the compounded formula. “The only way KV Pharmaceutical can stop the compounding of 17-OP is to go to after the source manufacturers of the bulk 17-OP powder and convince them to stop selling to compounding pharmacies,” she wrote on her blog at www.preemieprimer.com.
In a separate blog post, Gunter argues that there is legal precedent regarding another form of progesterone that received FDA approval. She wrote, “Abbott makes Prometrium, which is oral micronized progesterone. However, compounded oral micronized progesterone was available before Abbott got the drug FDA-approved, and it is still available. No lawsuits. No FDA action.”
The International Academy of Compounding Pharmacists issued a statement March 14 to patients explaining that “If in the professional judgment of both your prescriber and the pharmacist it is appropriate to compound a hydroxyprogesterone caproate product rather than using the now manufactured product, then you should be able to obtain the compound.”
Eli Reshef MD heads a coalition of OBs in Oklahoma to boycott Makena until the price is “drastically lowered.” On his website he writes, “As physicians who care about their patients, several of us who practice OB/GYN in Oklahoma decided to respond. After ascertaining that 17-OHPC can be compounded by several local pharmacies at a fraction of the cost of Makena, we are recommending to our colleagues to ignore Makena and use the generic brand.”
If you and your health care provider determine that a hydroxyprogesterone caproate injection created by a compounding pharmacy is the more clinically appropriate choice for your individual circumstances, you can find a compounding pharmacy through the International Academy of Compounding Pharmacists by calling 1-800-927-4227.
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HOW TO OBTAIN A PRESCRIPTION AND SEEK FINANCIAL AID FOR MAKENA PROGESTERONE INJECTIONS
The progesterone injections known for the past decade as 17P are now sold through K-V Pharmaceutical and its subsidiary Ther-RX as an FDA-approved drug called Makena. The manufacturer of Makena set a list price of $1500 per injection, to which doctors, women's health care organizations and individuals expressed a range of emotions from fear to outrage.
KeepEmCookin.com spoke with a representative for Ther-Rx to find out how women currently on 17P can transfer their prescriptions to Makena and how all women can seek financial aid for Makena treatment.
If you’re currently receiving 17P injections or will be receiving them in a future pregnancy, you or your doctor can print out the form here. The top portion needs to be signed by the patient. The rest of the form needs to be filled out and faxed by the healthcare provider, along with the prescription. From there, a customer/physician support service called the Makena Care Connection will conduct an insurance benefits investigation on behalf of the patient and then contact the patient about the level of coverage.
Once insurance coverage has been established, a reimbursement specialist from Makena will review the patient’s eligibility for financial assistance. A spokesperson for Ther-Rx told us, “Ther-Rx recognizes that even when Makena is covered by the insurance provider, some patients may need financial assistance.” Three programs are available:
1. The Makena Co-pay Assistance Program provides direct assistance to reduce co-pay costs for patients who may be under-insured or in need of additional financial support.
2. An Alternate Funding Investigation seeks state or local programs that provide prenatal care and drugs at little or no cost to the patient.
3. The Makenna Patient Assistance Program offers drugs at no cost or reduced cost.
Gross annual household income is the basis for eligibility for the Makena Patient Assistance Program. Proof of income includes the most recent tax return, the most recent W-2 or 1099 for the household, a letter from social security stating income or one month’s worth of pay stubs. There are additional eligibility requirements, such as being a U.S. resident and having a Makena prescription, and these can be discussed on patient-by-patient basis with a representative from the Makena Care Connection. Call 1-800-847-3418, from 8 a.m. to 9 p.m. EST, Monday through Friday. You can visit the Makena website at www.Makena.com.
We encourage you to rate your experience with the Makena Care Connection here.
THE MARCH OF DIMES WILL HOLD Ther-Rx TO THEIR PROMISE TO ENSURE PATIENT ACCESS TO MAKENA
Today the March of Dimes issued the following statement about the $1500-per-injection cost of Makena, the brand-name progesterone injection previously referred to as 17P.
"Thank you to everyone who has shared their concerns about the cost of Makena. We agree that the price of Makena is too high. We've shared our concerns about the price with Ther-Rx in the past and will do so again today. Ther-Rx has promised that every eligible woman will get care regardless of their ability to pay and we will hold them to that promise. We will also work with insurance companies and Medicaid to be sure that there is coverage. The needs of moms and babies are our only priority and your voices will be heard."
Keep 'Em Cookin' contacted a representative of Ther-Rx March 9 with questions about the level of coverage to be provided by insurance companies, hospitals, and state and federal agencies.
A spokesperson for Ther-Rx, from the public relations firm Golin Harris, did not provide a detailed answer but did write the following:
"Given the extremely high potential costs of preterm birth and the known risk for a subsequent preterm birth in patients with a history of preterm birth, we believe that health insurance plans will recognize the value of FDA-approved Makena for clinically eligible patients. Ther-Rx understands that preterm birth is a complex, multifactorial issue, and will work in concert with everyone involved in the care of women at risk for preterm birth, including healthcare providers and payers to help ensure that all eligible patients have access to Makena."
Keep 'Em Cookin' will continue to seek more information and provide updates as we learn more.
For questions about your prescription and coverage, call the Makena Care Connection at 1-800-847-3418 from 8 a.m. to 9 p.m. EST, Monday through Friday.
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COST OF 17P INJECTIONS SOAR TO $1500 PER SHOT: FINANCIAL ASSISTANCE IS AVAILABLEProgesterone injections, also known as 17P, will be sold under the brand name Makena at a cost of $1500 per dose, according to an Associated Press article published March 9. For women who receive all 20 weeks of treatment to prevent preterm birth, the total cost will be $30,000. Makena will be available by prescription beginning March 14, at which time the drug will no longer be available through compounding pharmacies, which typically charged $10 to $20 per injection.
The maternal-fetal care community has previously supported the FDA approval of Makena because it would bring consistency to the drug, greater awareness of the benefits of 17P, and presumably more likely coverage by government-supported programs and state-run programs like Medicaid. Now, the extent to which hospitals, state programs, and insurance companies will help to cover this unexpected price tag is unknown. KeepEmCookin.com has contacted the manufacturer, K-V Pharmaceutical Company, for additional information about who will cover the cost of Makena.
K-V Pharmaceutical Company and its subsidiary Ther-RX have launched a financial assistance program as part of the Makena Care Connection, which provides a single source for administrative, financial, and treatment support for patients and healthcare providers.
The financial support program for Makena offers assistance to both uninsured and insured patients, and is based on income. According to K-V Pharmaceutical:
Insured patients with annual household incomes of up to $100,000 who apply for and are eligible for co-pay assistance will have a co-pay of $20 or less per injection for Makena.
Uninsured patients with annual household incomes of up to $60,000 who apply for and are eligible for patient assistance will receive Makena at no cost. Uninsured patients with annual household incomes between $60,000 and $100,000 will be able to acquire Makena at a cost that is comparable to the average co-pay assigned by commercial insurance plans.
Makena will not be carried by retail pharmacies. The prescription process for Makena will be managed by the Makena Care Connection, which is available by calling 1-800-847-3418 from 8 a.m. to 9 p.m. EST, Monday through Friday.
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FDA WARNS AGAINST USING TERBUTALINE TO PREVENT PRETERM LABORIn a safety announcement released today, the FDA advises clinicians against using injectable terbutaline to prevent preterm labor or treat it beyond 48 to 72 hours because of the risk for maternal heart problems and death. Also, oral terbutaline should not be used for the prevention or any treatment of preterm labor because it shares the same safety risks as the injectable version and has not proven to be effective.
Terbutaline is generally used to treat asthma and other breathing conditions, but it has also been commonly used "off-label" to treat preterm labor. Terbutaline relaxes the smooth muscles of the uterus to slow contractions. The FDA has determined that the cardiovascular risks outweigh any potential benefit to pregnant women receiving terbutaline by injection or by infusion pump on a prolonged basis, or any treatment with the oral tablet version of the drug.
The FDA statement acknowledges that there are serious situations where a healthcare professional may decide that the short-term use of injectable terbutaline may benefit a pregnant woman, but stated that such treatment should not extend beyond 48 to 72 hours. This amount of time allows the administration of corticosteroid injections for fetal lung development and to move the mother to a hospital with a neonatal intensive care unit, if necessary.
"Although it may be clinically deemed appropriate based on the healthcare professional's judgment to administer terbutaline by injection in urgent and individual obstetrical situations in a hospital setting, the prolonged use of this drug to prevent recurrent preterm labor can result in maternal heart problems and death," the statement said. Terbutaline should not be used in an outpatient or home setting.
FDA APPROVES USE OF 17P INJECTIONS TO REDUCE THE RISK OF PRETERM BIRTHThe U.S. Food and Drug Administration has granted approval for the use of hydroxyprogesterone caproate 17P injections to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. This is the first time the FDA has approved a drug for the prevention of preterm birth.
The effectiveness of the drug, to be marketed under the name Makena, is based on a study of 463 women who had experienced a previous singleton spontaneous preterm birth. The study, sponsored by the National Institutes of Health, showed that compared to controls, treatment with Makena reduced the proportion of women who delivered at less than 37 weeks gestation. Among women treated with Makena, 37 percent delivered preterm before 37 weeks as compared with 55 percent of women in the control group.
Hydroxyprogesterone caproate 17P injections have been prescribed by doctors in the past as a treatment for preterm birth prevention, but the drug had to be obtained from compounding pharmacies, which could be costly, not necessarily covered by insurance, and the quality could be inconsistent. With FDA approval of Makena referred to as Gestiva in prior stages of the FDA approval process the drug will become more widely available to women who qualify for the treatment.
A published study by the March of Dimes, the National Institutes for Health, and the Centers for Disease Control and Prevention, using data from 2002, estimated that if all women eligible for the progesterone injections received them, nearly 10,000 spontaneous premature births might be prevented each year.
Since 2003, the American Congress of Obstetricians and Gynecologists has recommended that doctors offer progesterone treatments to high-risk women.
"As an obstetrician specializing in high risk pregnancies and a mom of two, I know that every week of pregnancy counts," said Ashley Roman, M.D., MPH, Clinical Assistant Professor, Department of Obstetrics and Gynecology, NYU Langone Medical Center. "I have confidence in the safety and efficacy profile of Makena to reduce the risk of another preterm birth for women who are eligible for therapy."
Learn more about 17P injections, such as their effectiveness and how they are used, here.
PATENT EXPECTED FOR THE USE OF PROGESTERONE TO PREVENT PRETERM BIRTHThe U.S. Patent and Trademark Office has issued Watson Pharmaceuticals a Notice of Allowance for a key patent for the use of progesterone to treat or prevent preterm birth. The patent is expected to be issued within three months upon payment of required fees.
The new patent pertains to the use of progesterone to treat women with a short cervix at mid-pregnancy to prevent spontaneous preterm birth. A short cervix at mid-pregnancy is the single most important predictor of preterm birth. The patent will cover the progesterone gel marketed as CRINONE and PROCHIEVE, along with any next-generation progesterone gel products used to prevent preterm birth, until at least February 2028.
CRINONE is currently used for progesterone supplementation or replacement as part of an Assisted Reproductive Technology ART treatment for women with a progesterone deficiency. The product is also available under the trade name PROCHIEVE and available in both 4% and 8% concentrations. CRINONE/PROCHIEVE 4% is indicated for the treatment of secondary amenorrhea.
A Phase III clinical trial called the PREGNANT Study PROCHIEVE Extending GestatioN A New Therapy is currently underway to evaluate the safety and efficacy of PROCHIEVE to reduce the risk of preterm birth in women with a cervical length between 1.0 and 2.0 centimeters as measured by transvaginal ultrasound at mid-pregnancy. The primary endpoint of this study is a reduction in the incidence of preterm birth at less than or equal to 32 weeks gestation versus placebo. Top-line study results are expected in December. If the data are positive, a New Drug Application NDA filing will follow in 2011.
DEPRESSION DURING PREGNANCY INCREASES RISK OF PRETERM BIRTHClinical depression puts pregnant women at increased risk of delivering prematurely and of giving birth to below-normal weight infants, according to a report published Oct. 4 in the Archives of General Psychiatry.
Being born too soon and weighing too little at birth can jeopardize the immediate survival and long-term health of babies. Preterm birth and low birth weight are leading causes worldwide of infant and early childhood mortality, respiratory distress, neurological and developmental impairment, cerebral palsy, blindness, hearing loss and other disabilities.
Depression is common during pregnancy as well as at other times in a woman's life. Between 9 to 23 percent of women experience clinical depression while pregnant.
"In the United States, the likelihood of experiencing premature birth is even greater for depressed pregnant women living in poverty than for depressed pregnant women from middle- to high-socioeconomic backgrounds," said the lead author of the report, Dr. Nancy Grote, University of Washington UW research associate professor of social work. Compounding the situation, she added, "Poor women in America are twice as likely to experience depression, compared to other women in this country."
Depressed, pregnant women living in European social democracies fared better than poor pregnant, depressed women in developing nations or in the United States, the Oct. 4 paper reported. European women had lower rates of premature births and low-birth weight infants. Social democracies offer universal health care and tend to have fewer socio-economic disparities in birth outcomes. Living in a developing nation or in poverty in the United States, where adequate prenatal, medical and mental health services may be lacking, could add to the harmful effects of depression during pregnancy on birth outcomes, the Oct. 4 paper suggested.
A multidisciplinary group of researchers at the UW, The Ohio State University, and the University of Pittsburgh conducted the study.
Previous reports over the past decade on the association between depression during pregnancy and preterm birth and low-birth weight infants have provided an inconsistent and inconclusive picture, the researchers noted. The researchers for this project performed a meta-analysis of all available United States and non-United States studies and used rigorous state-of-the-art guidelines to examine the data.
Dr. Jeffrey Bridge of The Research Institute at Nationwide Children's Hospital and Department of Pediatrics of The Ohio State University conducted the statistical analyses for the study. The results affirmed the strength of the link between depression during pregnancy and negative birth outcomes.
LEGISLATION INTRODUCED TO REAUTHORIZE THE PREEMIE ACTSenators Lamar Alexander and Chris Dodd introduced legislation to reauthorize the PREEMIE Act to continue and enhance federal support for research into the causes and prevention of premature birth and to reduce infant mortality caused by prematurity.
"The 2006 enactment of PREEMIE drove critically needed attention and resources into research to address the epidemic of premature birth," said Jennifer L. Howse, PhD, president of the March of Dimes. "Now four years later, due to the innovative work of scientists and clinicians across the nation, many supported by the original PREEMIE Act, we are seeing progress for the first time in three decades in the form of a two-year drop in rate of preterm birth."
The bill calls for expanding the scope of work supported by the National Institutes of Health, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration to include new initiatives ranging from the creation of trans-disciplinary research centers and additional epidemiological studies to telemedicine and a national education campaign.
You can view the text of the bill here.
HEALTHIEST PREGNANT WOMEN FEEL A STRONG SENSE OF COMMUNITYA new University of Michigan study compared African American and European American women and women of lower and higher socioeconomic status to see what effects a strong sense of community had on African American women and women of lower socioeconomic status.
The study followed 297 African American and European American women through 32 weeks of pregnancy. Results suggest that a sense of community was more important for a pregnant woman's mental health than ethnicity or socioeconomic status over the lifespan, said Cleopatra Abdou, a social health psychologist who completed the study as a Robert Wood Johnson Foundation Health and Society Scholar at U-M School of Public Health.
The pregnant African American women and women of lower socioeconomic status had overall higher levels of stress, negative effect and blood pressure than women of higher status based on race or education and income. However, these ethnic and socioeconomic disparities were not observed among women with higher communalism.
The findings of Abdou and her colleagues also suggest that communalism negates the effects of ethnic minority status and lower socioeconomic status on a pregnant woman's blood pressure.
"This paper suggests that it can be very important to distinguish culture from ethnicity and social status, not only as concepts, but also in terms of effects on health and other important life outcomes," said Abdou, who starts this fall as assistant professor at USC in the Davis School of Gerontology.
"I think it's critical to put these results in context. Communalism is associated with better health, especially for women of color and women who have experienced socioeconomic disadvantage at some point in the lifespan," Abdou said. "Nevertheless, we see very clear evidence that higher socioeconomic status is associated with higher communalism, regardless of your ethnic background. It seems that it's just easier to have more of every type of resource, including cultural resources, in this case communalism, when you have more money."
The paper is scheduled to appear this month in the American Psychological Association's Journal of Cultural Diversity and Ethnic Minority Psychology.
STUDENTS DESIGN EARLY LABOR DETECTOR TO HELP PREVENT PREMATURE BIRTHSJohns Hopkins biomedical engineering students wanted to improve the way doctors detect preterm labor. They designed and built a prototype that is now undergoing testing in animals. With further refinement, the students say, their system could eventually help physicians discover early signs of labor and allow the doctors to delay preterm deliveries, giving these babies more time to mature.
“The problem is, the technology now used by most doctors usually detects preterm labor when it’s so far along that medications can only delay some of these births for a few days,” said Karin Hwang of Ontario, Calif., one of the student inventors. “But if labor can be detected earlier, medications can sometimes prolong the pregnancy by as much as six weeks.”
Hwang was one of four Johns Hopkins students who devised and built the system in a yearlong bioengineering innovations and design master’s degree program. The others were Deepika Sagaram of Philadelphia; Rose Huang of Brooklyn, N.Y.; and Chris Courville of Lafayette, La. Along with their faculty sponsor, Abimbola Aina-Mumuney, an assistant professor of maternal fetal medicine in the Johns Hopkins School of Medicine, the students have formed CervoCheck, a limited liability corporation, to advance the project.
The students met Aina-Mumuney last year, early in their degree program, when they were asked to follow physicians on their hospital rounds and discover which new instruments and devices the doctors needed most to improve patient care. “I told them it’s really important to know at the earliest possible point when a pregnant patient is contracting,” said Aina-Mumuney. “It’s something I’ve had a strong interest in.”
The students initially proposed a new blood test to find proteins associated with early labor, but Aina-Mumuney steered them toward building a better device to detect physical signals in the expectant mother’s body. To find signs of preterm labor, physicians have long relied on a tocodynamometer, a belt that is attached to a woman’s abdomen for external monitoring of uterine contractions. But Aina-Mumuney said this device is not effective at picking up preterm labor very early in a pregnancy or in cases where the patient is obese. “I suggested that the students come up with an internal device,” she said. “I told them that if we could bypass the abdomen, that would be ideal.”
After much research and brainstorming, the students built a prototype ring made of medical grade biocompatible silicone elastomer. The ring is designed to be compressed and inserted into the vaginal canal at a physician’s office or hospital. Embedded within the ring are sensors designed to pick up electrical signals associated with uterine contractions.
“With these sensors, we’re detecting signals directly from the places in the body where they originate, as opposed to trying to pick them up through the abdominal wall,” said Courville, one of the inventors.
The prototype has not yet been used on human patients, but the students say their early animal test results are promising and that improvement of the system is continuing. Their faculty advisor, Aina-Mumuney, said she is pleased by the great enthusiasm that the biomedical engineering students brought to the project. “They can truly see the impact this could make,” she said. “If we can detect preterm labor at an earlier point and can delay the delivery by six weeks or more, the risk of the baby being born with serious health problems will go down dramatically.”
The inventors of the CervoCheck device say their system may someday help to reduce such expenses. “We estimate that the cost savings could be more than $44,000 per patient for every preterm birth we could prevent,” co-inventor Hwang said.
Working with the Johns Hopkins Technology Transfer office, the students and Aina-Mumuney have obtained a provisional patent covering their invention and established CervoCheck, LLC. The students also have received high marks and prize money in several competitions in which the viability of their device and its sales potential were judged. The team placed first in the University of California, San Francisco, Business Plan Competition; won second-place honors in business plan contests sponsored by the University of Texas at Arlington and Noetic Technologies, and placed third in the University of Louisville Cardinal Challenge and the Johns Hopkins University Business Plan Competition.
All four students recently received their master’s degrees from Johns Hopkins. Sagaram will be entering medical school at Brown University, and Courville has accepted a job at a healthcare software business. Team members Hwang and Huang have opted to work full-time on moving the CervoCheck device toward commercial use. “We’re passionate about seeing this become a reality,” Hwang said.
A NEW DEVICE FOR MEASURING CERVICAL LENGTH PROVIDES IMMEDIATE RESULTSA new tool for quickly measuring vaginal cervical length was introduced to the medical community yesterday at the American Academy of Obstetricians and Gynecologists annual meeting in San Francisco, California. The device, called CerviLenz, is inexpensive, disposable, and can provide results immediately.
A short cervix is a proven indicator of an increased risk of preterm birth. The length of the cervix is typically measured by transvaginal ultrasound, which can be expensive, and the equipment and a technician may not always be available. The CerviLenz can be inserted to provide a cervical length measurement to the nearest millimeter immediately, in the office or at Labor & Delivery triage. See how it works here. This gives doctors and their patients the information to determine what steps to take next, such as hospital observation, home bedrest, progesterone supplementation or other diagnostic tests.
CerviLenz was invented by Dr. Rosalyn Baxter-Jones, an OBGYN in San Diego, California, who was inspired by her need for a simple, low-cost way to identify patients who may be at high risk of preterm birth.
2D ULTRASOUND MEASUREMENT OF THE FETAL ADRENAL GLAND ACCURATELY PREDICTS RISK OF PRETERM BIRTHMeasuring the fetal zone of the adrenal gland with 2D ultrasound to predict preterm birth is as effective as using less available 3D imaging to measure fetal adrenal gland volume. Both are more accurate than the conventional technique of measuring cervical length.
"We previously discovered that 3D adrenal gland volume is a very accurate predictor of preterm birth," said Dr. Ozhan Turan, the study's author. "However most people around the world don't have access to that technology, therefore, we have created measurements that can be done with 2D ultrasound that are very effective to predict pre-term birth."
"Prior to this we haven't had a good method to predict who will present with pre-term labor." said Dr. Turan. "Measuring the cervical length leads to a high percentage of false positives and also it has limited sensitivity," he continued. "Hopefully, if adopted, this method will allow for an easy inexpensive way to identify real pre-term deliveries. Therefore we will be better managing these pregnancies."
The study was presented at the Society for Maternal-Fetal Medicine 30th Annual Meeting: The Pregnancy Meeting.
UNIVERSAL SCREENING FOR SHORT CERVIX BY ULTRASOUND CAN REDUCE PRETERM BIRTHSUsing ultrasound to screen all pregnant women for signs of a shortening cervix improves pregnancy outcomes and is a cost-effective way to reduce preterm birth, report Yale School of Medicine researchers in a new study.
Shortened cervical length increases the likelihood of a preterm birth. All high-risk patients—those who have had a prior preterm birth—are routinely screened at 20 to 24 weeks gestation to test for cervical length. However, screening is not often given to low-risk pregnant women, and researchers did not know whether it was cost-effective to screen women at low risk.
Erika Werner, M.D., clinical instructor in the Department of Obstetrics, Gynecology & Reproductive Sciences at Yale, found that screening low-risk women is not only cost effective, it is cost-saving.
Werner and her team developed a computer model to mimic the outcomes and costs that occur when women are screened routinely, compared to when no screening occurs. They found that universal screening was cost-effective when compared to routine care. In fact, for every 100,000 women, routine care costs $6,523,365 more than the screening strategy. It also improved quality of life and resulted in fewer neonatal deaths and infants with long-term neurological disorders.
“Since only 10 percent of preterm birth occurs in women with a history of preterm birth, cervical length screening may be the best way to decrease the number of babies born prematurely,” said Werner.
Other Yale authors on the study included Christina S. Han, M.D., Christian M. Pettker, M.D., Catalin S. Buhimschi, M.D., Joshua A. Copel, M.D., Edmund F. Funai, M.D., and Stephen F. Thung, M.D."
NEW RESEARCH SHOWS GENETIC LINK TO PRETERM LABOR RISKA new study shows that the genes of both the mother and the fetus can make them susceptible to an inflammatory response that increases the risk of preterm labor and birth.
Silent, undetected infections and inflammation are major risk factors for preterm labor and birth, says Roberto Romero, MD, Chief of the Perinatology Research Branch at the National Institute of Child Health and Human Development. One of every three preterm births occurs to a mother who has an infection in her uterus, but has no symptoms.
Dr. Romero led a team of physicians and scientists studying a large number of genes involved in the control of labor that could help explain the complex process that triggers preterm birth. They found DNA variants in genes involved in fighting infection in the pregnant woman and the fetus. Although these variants increased the risk of preterm labor and birth, they have been preserved by evolution because they are needed to fight infection, Dr. Romero said.
"This research gives us even more evidence as to the relationship between genetics and preterm birth and is a step toward personalized medicine," said Alan R. Fleischman, MD, medical director of the March of Dimes. "This has the potential to allow us to identify a woman who is at risk for delivering early and provide her with specialized, individualized care so that she may carry her baby to term, and help give more babies a healthy start in life."
STUDY SHOWS COMMON ANTIBIOTIC NOT EFFECTIVE IN PREVENTING PRETERM LABORResearchers at Liverpool University tested whether using the drug azithromycin to treat bacteria before it is detected would prevent early childbirths, defined as births before 37 weeks of gestation.
"Infection can occur early in pregnancy and remain undetected, so one way of reducing incidences of preterm labor may be to administer antibiotics before patients display any signs of infection," said Jim Neilson, professor at Liverpool University's School of Reproductive and Developmental Medicine. "Our study showed, however, that treating infection with azithromycin had no impact on reducing incidences of preterm labor."
U.S. EARNS A "D" ON PREMATURE BIRTH REPORT CARDToday the March of Dimes released its annual Premature Birth Report Card. Overall, the United States received a grade of “D.” The rate of premature birth in America is higher than that of most other developed nations, with one in eight babies born premature in our country. Click here for your state’s results and to learn more.
NOVEMBER IS PREMATURITY AWARENESS MONTHAll month long, KeepEmCookin.com will be hosting a Q & A with three guest obstetricians. They'll be available to answer your questions about preterm labor, preterm birth, and pregnancy after a preemie. Please e-mail your questions to email@example.com. Look for new questions and answers on our Pregnancy After A Preemie page.
CERVICAL LENGTH PLUS fFN TEST: STRONG PREDICTOR OF PRETERM BIRTH IN TWIN PREGNANCIES
In twin pregnancies where no symptoms of preterm labor are present, the combination of fetal fibronectin testing and cervical length testing between 22 and 32 weeks gestation can identify pregnancies that are at a significantly increased risk for preterm birth, according to a study published in the September 2009 issue of American Journal of Obstetrics & Gynecology.
Researchers retrospectively reviewed the pregnancies of 155 women pregnant with twins, comparing those who had fFN testing, those who had cervical length testing, and those who had both tests, at any point from 22 to 32 weeks gestation. A positive fFN test result from 22 to 32 weeks or a cervical length of less than 2.0 cm showed an increased risk of 8.3 percent for spontaneous preterm birth. The combination of a positive fFN test result and a cervical length of less than 2.0 cm was an even greater predictor for preterm delivery than either positive test alone. Specifically, the risk for spontaneous preterm birth at less than 32 weeks was 54.5 percent in instances where women had both a positive fFN and a cervical length less than 2.0 cm.
"It appears that screening asymptomatic twin pregnancies, which also pose a high risk for preterm birth, with fFN result and cervical length is a useful strategy for the determination of which women are at higher and lower risk for preterm delivery," the study's authors wrote.
STUDY SHOWS LINK BETWEEN FETAL FIBRONECTIN TESTING AND TREATMENT DECISIONS
Researchers at King’s College London concluded that that fFN testing has the potential to improve risk assessment and impact treatment decisions, including the administering of steroids, increased surveillance, or cerclage intervention in the asymptomatic high-risk population involved in the study.
“The results of our study clearly indicate that fFN testing influenced management in a significant number of patients. A large number of women were asymptomatic at testing. Fetal fibronectin testing could be offered more widely and has the potential to benefit patient management,” said Prof. Andrew Shennan, study co-author and Ob/Gyn at St. Thomas’ Hospital in London, England.
Conducted at the Maternal and Fetal Research Unit at St. Thomas’ Hospital in London, the study included nearly 100 patients between 23 and 34 weeks gestation. After using the fFN test with women who had clinical symptoms showing a risk of preterm birth as well as with women without symptoms, clinicians were asked to determine if the results from the test changed the medical management of their patients. Clinician responses indicated that fFN testing had the potential to change management in nearly 90 percent of cases.
“Another important benefit of fFN testing,” Shennan said, “is the ability to avoid overtreatment of women with negative test results. In addition to providing assurance to women and their doctors that preterm birth is not imminent, fFN testing—if more widely used in the asymptomatic population—could also translate into significant cost savings to the health care system.”
The fetal fibronectin test assesses the risk of preterm birth in women from 22 to 35 weeks gestation with known risk factors or with signs and symptoms of preterm labor. The fFN test measures the presence of fetal fibronectin, the glue-like substance that holds the baby in the womb. A negative result means fetal fibronectin is minimally present and there is a less than one percent chance of delivering in the next two weeks. A positive result is a strong independent predictor of preterm birth before 32 weeks.
More information on the fetal fibronectin test can be found at www.fullterm.net. The study was published in the online version of the European Journal of Obstetrics & Gynecology and Reproductive Biology.
MEN: 10 TIPS FOR KEEPING YOUR BED REST MAMA HAPPY
By Scotty SchrierI won't say it has been easy. My amazing wife we’ll call her Lilcapmom has been in the hospital for almost 3 weeks now. Lilcapmom is a perpetually busy woman. She likes to be in a constant state of movement, so this bed rest has been a special level of hell for her. I have tried to make her stay in the hospital as comfortable as possible by implementing the following ideas for dads.
1. Nintendo DS
This is a must! There are so many games out there that are catering to adults now, that you aren't going to be stuck with some kiddie title. If mama likes mysteries, then there are several titles to enjoy. Not to mention all of the brain-teaser/puzzle variety games. I also got one for myself and we can play several games together even with owning only one copy of the game.
Comfort food. Home-cooked food. Whatever her favorite food is. Hospital food is decent at best.
3. Comfort Food
I listed it again, because nothing beats the melancholy monster quite like some ice cream.
4. Vanity-type Products
Being laid up in a hospital can be enough to make any woman feel less than beautiful!
a. Scented lotions
b. Hair ties
c. Scented room spray run this by the nurse first
There's more you can do; these are just a few examples. You know what your lady likes. Make it happen!
5. Beauty Treatments
Arrange for a nail technician or hair-dresser to come in. I talked to the woman who cuts our hair and she was more than happy to come in and give Lilcapmom a haircut. Lilcapmom was SO excited! It really raised her mood for a couple of days afterwards. You can NOT put a price on that smile.
Take care of the nurses who are taking care of your family! I cannot stress this enough! I watched the entire floor light up when I spent $5.99 on a dozen assorted doughnuts and brought them in for breakfast for our nurses. Trust me, if you show them how much you appreciate everything they do, they will work that much harder to make sure that your stay is enjoyable. You may call it bribery...I call it Goodwill Insurance. You will NOT regret it, I promise!
7. Pity Parties
If you wife is on the pity pot...LET HER! She's going to be upset and moody... She's pregnant and now has NO independence. Lilcapmom cried one night because she didn't want to have to hit the nurse button just to plug her Nintendo DS in. Bed rest is NOT a vacation any more than a prison sentence is. Being treated like an invalid has a way of demoralizing a person. This is YOUR time to shine dad! Be the man that every woman wishes she had. If you act like an ass now...you will NEVER live it down. What I'm trying to say is that even if you think she's being irrational, chances are she thinks it too...but is powerless to do anything about it. Just hold her and make sure you have tissues for her.
8. No Complaining
Do NOT complain about what a burden you think this is on you. She's going to feel badly enough about not being able to do the normal things in life. She does NOT need to feel like she's inconveniencing you in any way. I don't care if you are only getting 2 hours of sleep a night, you can't let her know how tired you are. She already feels guilty, and pregnancy-induce guilt is ten times worse than any other kind. Steer clear of it at all costs! If her bed rest happens during the “nesting” phase, be prepared for her to be upset about not being able to help finish the baby's room.
9. Give Yourself a Break
Take some time to give yourself a break as well. Man, you are going to run your butt off and be asked to handle things that you weren't expecting. Make sure that you aren't running yourself into the ground needlessly. If the kitchen goes to hell while she's in the hospital, that's fine as long as it gets cleaned by the time she gets home. In that hour you were going to use to clean the kitchen, have a beer and relax a little. No one in their right mind could hold it against you.
10. Create a Support Team
Make sure there is a support net of some sort. Give her options of people she can vent to. That way you won't be the focal point of ALL of her frustrations. This will lead to fewer hurt feelings and much less animosity. You also need to vent about things as well. You can't vent on each other; otherwise you WILL end up in an argument. And you do not want to be THAT guy!
This is just a starter list. Mostly just remember that what she is doing right now is possibly the single most important moment in your child's life. Bed rest is given for a reason. And mama is going to need every ounce of support you can give her right now.
Now go out there and be the best damned daddy you can be! It starts way earlier than the day they come out...
Scotty Schrier is an aspiring author and dad-to-be. He currently resides with his wife and pets in Tampa, Fla., and is anxiously awaiting the arrival of their first child. To see more of his writing you can go to www.bleedingsweat.com for his archive of short stories.
HOW TO MAINTAIN MUSCLE TONE WHILE ON BED REST
And also help speed your bed rest recovery
By Darline Turner-Lee
Bed rest is seldom in any woman’s plan for her pregnancy. Yet each year some 700,000 to 1 million women willingly succumb to their obstetricians’ bed rest prescriptions to ensure the best hope for their babies.
However, bed rest is not without risk. Numerous research studies report that inactivity—even for as short a time as two weeks—results in loss of muscle mass and strength. NASA studies done to evaluate the effects of weightlessness on female astronauts found that in 60 days women lost up to 25 percent of muscle mass and nearly half of their muscle strength.
Pregnant women prescribed bed rest are often inactive for months at a time. As a result, pregnant women on bed rest are at increased risk of developing blood clots in their legs that could dislodge, then travel to the heart, lungs or brain and be fatal.
So what is a woman on bed rest to do, not only to guard against these potential health risks but also to speed her recovery postpartum I recommend engaging in modified exercises while on bed rest. Each woman’s circumstances are unique, so consult with your obstetrician or midwife before performing these exercises.
The following four exercises are samples of exercises that women on bed rest can do to stimulate their leg muscles, increase blood circulation and reduce the risk of a blood clot forming in the legs. They can be done with a rubber exercise band or with a long bath towel to provide a bit of resistance. Do them two to three times a day.
Quad/Hamstring Curls: Lay on your side with your body straight. Wrap the towel around your top foot and hold the ends of the towel in your hand. Slowly bend your top knee bringing your foot the heel to your buttocks. Release to starting position and repeat 10 times on each side.
Quadriceps Extensions: Sit upright in bed comfortably propped up with pillows. Wrap the towel around both feet and hold an end in each hand. Slowly slide your feet towards you, bending your knees and using the towel for assistance. Only go as far as is comfortable. If you feel pressure in your lower abdomen, stretch your feet back out! Then slowly push your feet back out, giving a bit of resistance with the towel. Repeat 10 times.
Abduction/Adduction: Sit upright in bed comfortably propped up with pillows. Wrap the towel around both feet and hold an end in each hand. Slowly open your legs to a wide “V”, holding the towel firmly to provide a bit of resistance. Slowly bring your legs back together using the towel to assist. Repeat 10 times.
Calf Stretches: Sit upright in bed comfortably propped up with pillows. Wrap the towel around the balls of the feet and hold an end in each hand. Slowly point and flex your toes, tightening and releasing your leg muscles. Repeat 10 times.
You can also perform these exercises if you are released from bed rest before delivery, to speed your recovery and help regain your strength.
Darline Turner-Lee is a physician assistant, ACSM Clinical Exercise Specialist and a certified perinatal fitness instructor. She developed and produced Bedrest Fitness, a full-body modified fitness program for pregnant women on prescribed bed rest. For more information or to purchase the DVD, visit www.mamasonbedrest.com.
STUDY: VETERINARIANS AT HIGHER RISK FOR PRETERM BIRTH
Long work hours and exposure to anesthetics may raise pregnant veterinarians' risk of premature delivery, a new study suggests.
To investigate possible occupational factor associated with prematurity, Dr. Adeleh Shirangi, of Imperial College London in the UK, and colleagues evaluated 399 female vets who had at least one baby. They found a higher rate of preterm delivery among those who regularly used anesthesia without a "scavenging" system for clearing excess gas from the operating room. Compared with other vets, women who had been exposed to unscavenged anesthesia gas for at least one hour per week were between two and three times more likely to delivery prematurely, Shirangi's group reported in the journal Obstetrics & Gynecology.
Similarly, vets who worked more than 45 hours per week were nearly four times more likely to have a preterm birth than those with shorter work weeks. The results add to an earlier study in which Shirangi's team found that several exposures in veterinary practice, including unscavenged anesthetics, X-rays and pesticides, seemed to raise the risk of miscarriage. The research suggests that female vets, and other women who work in the area, should take some precautionary steps, according to Shirangi.Source/Read more...
ESTROGEN LEVELS MAY ALLOW DOCS TO PREDICT AND PREVENT PRETERM LABOR
The trigger for the start of labor has been a mystery, but new research which will be published in an upcoming issue of the Journal of Clinical Endocrinology & Metabolism has yielded very important information about the interaction of hormones and the onset of labor. Researchers in Australia have found that the relative levels of two forms of estrogen, estradiol, E2, and estriol , E3, are involved in causing women to go into labor.
Researchers studied 500 pregnant women, and found that that the ratio of E3 to E2 rose rapidly as labor approached. When the levels of E2 and E3 were roughly the same, there was no drive for labor.
In a previous study, these researchers found that a placental hormone, corticotrophin-releasing hormone CRH , peaks at the time of labor and that CRH levels rise earlier in women who deliver prematurely. Now, they have also shown that CRH can act on the adrenal glands of the fetus, causing them to produce a steroid hormone that the placenta then uses to make E3. There is a strong correlation between CRH and E3 levels in the mother’s blood in the weeks before birth, which further supports the belief that CRH increases E3 levels.
CDC REPORTS SLIGHT DECLINE IN PRETERM BIRTH RATE
The annual percentage of preterm births in the United States dropped to 12.66 percent of all births in 2007, compared to 12.8 percent in 2006, according to preliminary data released by the CDC last week.
"It is a small victory, but still significant," says Angela Davids, founder of KeepEmCookin.com, an organization that educates women about the risk of preterm birth and the warning signs of preterm labor. "If the percentage of preterm births in 2006 had been the same as it was in 2007, there would have been 6,528 fewer babies born prematurely in 2006," Davids says.
The report, released March 18 by the Centers for Disease Control and Prevention’s National Center for Health Statistics, estimates that births in 2007 rose 1 percent to 4,317,119. This is the highest number of births ever registered for the United States, even surpassing the peak of the postwar Baby Boom. The end result is 546,547 preterm births for 2007, compared to 545,991 in 2006. For both years, that is 1 in 8 pregnancies that ended too soon, endangering the lives of newborns and presenting those who survived with a lifetime of potential health complications.
The preterm rate infants delivered at less than 37 weeks of gestation per 100 births has generally been on the rise for more than two decades, the report said. The 2007 decline was predominately among those born at 34 to 36 weeks, which is sometimes called “late preterm.” The late preterm rate, which has increased by more than 25 percent since 1990, was down slightly between 2006 and 2007, from 9.14 to 9.03 percent. The study also reported that the total preterm rate declined modestly among births to non-Hispanic white mothers from 11.7 to 11.5 percent, and non-Hispanic black mothers from 18.5 to 18.3 percent for 2006 to 2007, but increased slightly for Hispanic mothers at 12.3 percent, up from 12.2. The rates for American Indian or Alaska Native mothers dropped from 14.2 percent to 13.9, while the rates for Asian or Pacific Islander mothers remained the same at 10.9 percent.
In support of a continued decrease in the number of preterm births each year, KeepEmCookin.com will continue to place its greatest emphasis on educating pregnant women to recognize preterm labor symptoms. KeepEmCookin.com also helps women to identify their risk factors for preterm birth, and provides an online support group for women experiencing high-risk pregnancies.Source/Learn more...
FDA ADDS WARNING TO HEARTBURN DRUG REGLAN
Note: Women on bed rest are more likely to suffer heartburn, and their doctors may want to prescribe Reglan. Doctors may also prescribe Reglan to premature babies, to aid in digestion. Please strongly consider the new FDA warning.
Federal health officials are adding their sternest warning to a heartburn drug that has been linked to muscle spasms. The Food and Drug Administration said the drug metoclopramide , widely known as Reglan, has been shown to cause spasms and tics when used for long periods of time or at high doses. The problems include uncontrollable movement of the limbs, face and tongue, and are usually irreversible, even after patients stop taking the drug, according to the FDA's warning.
The agency is requiring drugmakers to add a black box warning, the most serious type available, to their products.
MARCH OF DIMES PROVIDES $2.7 MILLION IN NEW FUNDING FOR PRETERM BIRTH RESEARCH
Scientists intend to identify microbes that may cause preterm labor in some women, investigate the role of an enzyme in preventing uterine contractions and an early birth, and look at different groups of women to find genetic and environmental risk factors for prematurity.
The work of seven researchers will be supported for the next three years by new March of Dimes Prematurity Research Initiative PRI grants. The nearly $2.7 million in new grants continues March of Dimes support for efforts to predict and prevent preterm birth. These 2009 grants bring the five-year-old program’s grant total to nearly $14 million.
RESCUE COURSE OF STEROIDS IMPROVES OUTCOMES FOR PREEMIES
A new study shows that premature babies born before 34 weeks have a 31 percent reduction in serious complications when given a "rescue course" of Antenatal Corticosteroids ACS , with no adverse side effects noted. "Premature babies are very susceptible to respiratory problems which may lead to additional severe complications," said Dr. James Kurtzman, M.D. Associate Professor, UC Irvine Medical Center. "Antenatal steroids clearly reduce the risk of these respiratory complications."
Years ago, doctors gave multiple courses of antenatal steroids to mothers who were at risk for delivering prematurely. However, certain studies found that there were possible adverse affects to multiple ACS courses because babies were found to have slightly smaller head circumferences and lower birth weights. As a result, the National Institutes of Health NIH recommended further study.
"The effect of the NIH recommendation was that doctors were only giving one ACS course, and they were nervous about when to give it for the best effect. They often waited until the last minute, and some women didn't get a complete treatment or didn't get it at all," said Dr. Kurtzman. "What this study has found is that we can give women who threaten to deliver prematurely an initial ACS course, and if they remain pregnant, we can give one 'rescue course' closer to delivery. By doing so, the babies' complications are reduced by about a third with no adverse side effects found."
In this study, which took place over five years in 18 different medical centers and was supported by the Pediatrix Medical Group, 437 patients were randomized 233 in the study group, and 214 in the placebo group. The results showed a significant reduction in composite neonatal morbidity for babies born prior to 34 weeks in the "rescue steroid" group versus placebo 43.9 percent versus 63.6 percent as well as significant decrease in respiratory distress syndrome, ventilator support, and surfactant use. When all neonates were included in the analysis regardless of the gestational age at delivery, a significant reduction in composite morbidity in the "rescue steroid" group was still demonstrated 32.1 percent versus 42.6 percent .
The study was authored by James Kurtzman, M.D., University of California Irvine and Saddleback Women's Hospital; Thomas Garite, M.D., University of California Irvine; Reese Clark, M.D., and Kimberly Maurel, R.N., M.S.N., Pediatrix Medical Group on behalf of the Pediatrix Collaborative Research Network. The study will be published in the March 2009 issue of the American Journal of Obstetrics and Gynecology.
PREECLAMPSIA AND THE POTENTIAL FOR EARLY DIAGNOSIS
Clues to the cause of preeclampsia, a common, but serious hypertension complication of pregnancy that has puzzled doctors and researchers for decades, point to proteins that misfold and aggregate, according to Yale School of Medicine researchers.
These misshapen proteins can be easily detected in the urine, affording a new approach to early diagnosis of the disease, the Yale researchers report in new findings presented at the Society for Maternal Fetal Medicine scientific meetings in San Diego, Calif.
Preeclampsia is one of the most common causes of death in pregnant women in the United States and is responsible for about 76,000 maternal deaths worldwide each year. It is also a leading cause of preterm delivery. Delivery is the only reliable treatment for preeclampsia, and establishing a correct diagnosis can be difficult, especially in women with preexisting hypertension, lupus or kidney disease.
“These results support the hypothesis that preeclampsia is a pregnancy-specific protein misfolding disease,” said lead author on the abstract, Irina Buhimschi, M.D., associate professor in the Department of Obstetrics, Gynecology & Reproductive Sciences. “Our urine dye test is a rapid and non-invasive test that can be used to definitively diagnose preeclampsia.”
In a study of 111 pregnant women, Buhimschi and her team used proteomics to identify key abnormal proteins in the urine weeks before preeclampsia becomes clinically apparent. In order to carry out their individual functions properly, proteins must fold themselves correctly into three-dimensional structures. Misfolding, or failure to fold into the intended shape, produces proteins with different properties that are mainly guided by their shape rather than their amino acid sequence. Proteins of different amino acid sequences may share common shapes when misfolded.
Buhimschi and her team designed a test based on a dye that sticks to misfolded proteins. They analyzed the urine of women in the study starting in the first trimester of pregnancy. Buhimschi was able to use this simple test to identify a study participant who went on to develop severe preeclampsia and required early delivery.
Further work in Buhimschi’s lab, using conformation-specific antibodies developed in Charles Glabe’s laboratory at University of California-Irvine, showed that misfolded shapes similar to those found in Alzheimer’s disease are also present in the urine of preeclamptic women. In contrast to the misfolded proteins identified in Alzheimer’s disease, however, the misfolded aggregates identified in preeclampsia are composed of a group of different proteins, including SERPIN-A1 also known as alpha-1-antitrypsin .
“Our findings are compelling for several reasons,” said Buhimschi. “This novel identification of preeclampsia as a disorder of protein misfolding opens a door for researchers that may lead to testing of new drugs or developing new therapies. Our future work will seek to determine whether the different shapes employed by the misfolded proteins in preeclampsia are linked to specific clinical symptoms and the different ways this intriguing disease manifests.”
Other authors on the abstracts are Catalin Buhimschi, Margaret Baumbusch and Guomao Zhao from Yale School of Medicine; Charles Glabe from University of California-Irvine and Sabina Janciauskiene from the Wallenberg Laboratory in Malmö, Sweden.
THE EFFECTIVENESS OF 17P MAY HAVE A GENETIC LINK
New research may explain why taking progesterone to prevent preterm birth is effective for only some women, according to information presented today at the 29th Annual Society for Maternal-Fetal Medicine meeting. The drug, 17 alpha-hydroxyprogesterone caproate or 17P , is a synthetic form of the progesterone hormone naturally produced during pregnancy. It has been demonstrated in clinical trials to prevent some recurrent preterm births, but not all.
“This study helps strengthen the theory that genetic variation in the human progesterone receptor plays an important role in the effectiveness of 17P,” says Tracy Manuck, M.D., study author and SMFM member.
“Dr. Manuck’s research gives us a tantalizing clue as to why 17P works for some women, but not for others,” said Alan R. Fleischman, M.D., senior vice president and medical director of the March of Dimes. “With further research along these lines, we hope to someday be able to prevent preterm birth from happening in the first place by screening women before they get pregnant, and identifying those whose babies could get a healthy start in life with the help of 17P.”
The study assessed whether women with genetic variations known as single nucleotide polymorphisms SNPs in the human progesterone receptor gene were more or less likely to respond to 17P for the prevention of recurrent spontaneous preterm birth. All patients had at least one prior spontaneous preterm birth. The study extracted DNA from the saliva of 389 patients, and then genotyped 20 SNPs in the region of the progesterone receptor gene. Two hundred and fifty-eight 66 percent of the study participants received 17P and 131 34 percent received a placebo. Spontaneous preterm birth was less common among women who received 17P, as previous studies have shown.
After controlling for factors known to be associated with recurrent prematurity, multiple discoveries were made: Two SNPs were identified among African-American patients to be predictive of response to progesterone treatment. There was also an interaction between progesterone treatment and genotype of three additional polymorphisms for non-African-American women delivering very preterm less than 32 weeks gestation .
The study, The Relationship Between Polymorphisms in the Human Progesterone Receptor and Clinical Response to 17 Alpha-Hydroxyprogesterone Caproate for the Prevention of Recurrent Spontaneous Preterm Birth, was sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Unit Network and the University of Utah.
MOUTH BACTERIA COULD INCREASE RISK OF PRETERM LABOR
Previously undiscovered bacteria usually found in the mouth could be responsible for up to 80 percent of early preterm labors, estimate doctors from Case Western and Yale Universities in a new study published recently in the Journal of Clinical Microbiology.
Labor itself is still somewhat of a mystery to science, which makes puzzling out preterm labor even more difficult. Anything from socioeconomic status and race to bacterial infection and genetics have been linked to preterm births, but a definitive cause is still elusive. Researchers think they have found a major cause, at least in mice. By infecting the rodents with Bergeyella, a previously unknown bacteria found in the mice, the researchers caused preterm births.
In humans, the scientists showed a strong correlation between infection and preterm births. Doctors removed amniotic fluid from 46 different women with potentially higher risk pregnancies. Of that group, 21 delivered an early preterm baby 32 weeks or earlier. Nineteen of those women, or about 85 percent, were positive for previously undetected bacteria.The bacteria normally live in the mouth, but if a cut, cavity or other wound allows the bacteria to enter the blood stream, they can travel and eventually colonize the uterus. That triggers an immune response, which can inflame the uterus and eventually cause a mother to go into labor prematurely.
NEW DATA: PRETERM BIRTH RATE RISES AGAIN
Nearly 543,000 babies were born preterm in 2006, according to the National Center for Health Statistics, which today released "Births: Final data for 2006." The increase in the preterm birth rate represents 12.8 percent of all births. The percentage of infants delivered at less than 37 completed weeks of gestation has risen 20 percent since 1990. Most of this rise is attributable to the increases in "late" preterm births 34 to 36 weeks , up 25 percent since 1990. Preterm birth rates rose slightly for Hispanic infants, but were unchanged among non-Hispanic white and non-Hispanic black infants.
EDUCATIONAL LEVEL LINKED TO PRETERM BIRTH
Pregnant women with low levels of education are nearly twice as likely as their more educated peers to give birth prematurely, researchers from the Netherlands report. However, most of the risk can be attributed to the disadvantages that come with poor education, rather than educational level itself. In fact, as Dr. Pauline W. Jansen told Reuters Health, "Factors identified in this study, such as young age, stressful circumstances, smoking habits, and overweight are modifiable by up-to-date interventions." Jansen and her colleagues investigated the characteristics of 3830 pregnant women of Dutch origin, age 31 years on average. Among them, 1264 reported high education above the Bachelor's degree level while 638 reported no more than three years of secondary school the low group . The remaining women reported education levels somewhere in between. The researchers found that the women with the lowest educational level were 89 percent more likely to have a preterm birth than the most highly educated women. However, women with low education also seemed to accumulate psychosocial stress and unhealthy lifestyle factors "that turned out to be associated with their increased risk of preterm birth," Jansen and colleagues report in the Archives of Disease in Childhood—Fetal and Neonatal Edition.
EVEN "LATE" PRETERM BIRTHS STILL POSE SERIOUS RISKS
More than half a million babies are born preterm in the United States each year, and preterm births are on the rise. Late preterm births, or births that occur between 34 and 36 weeks approximately 4 to 6 weeks before the mother's due date , account for more than 70% of preterm births. Despite the large number of affected babies, many people are unaware of the serious health problems related to late preterm births. A new study and an accompanying editorial in The Journal of Pediatrics investigate the serious neurological problems associated with late preterm births.
Dr. Joann Petrini of the March of Dimes and colleagues from institutions throughout the United States studied more than 140,000 babies born between 2000 and 2004, ranging from preterm 30 to 37 weeks to full term 37 to 41 weeks . The researchers evaluated the babies' neurological development and found that late preterm babies were more than three times as likely to be diagnosed with cerebral palsy as full term babies. They also found that late preterm babies were at an increased risk for developmental delay or mental retardation.Editorialist Dr. Michael Kramer of McGill University points out that the "rates of preterm births are increasing, especially in the United States, and the associated risks are a serious public health concern." He sees the increasing number of twins and induced labors as contributing factors in the rise of preterm births. "The rise in twins may be due to the use of fertility treatments like hormones and in-vitro fertilization," Dr. Kramer explains. However, he notes that the increased risks may not always come from early delivery itself, but from other underlying problems, such as gestational diabetes, that may lead to early delivery.
According to Dr. Petrini, "The negative outcomes of many babies born late preterm can no longer be described as temporary or benign." She suggests that late preterm babies may benefit from neuron-developmental assessments and stresses that elective delivery through cesarean section or induction should not be performed before 39 weeks unless medically necessary. Additionally, Dr. Kramer urges mothers and families to be aware of the risks when considering infertility treatments and induction of labor.
FIRST-EVER PLACEBO-CONTROLLED TEST OF NIFEDIPINE
When a pregnant woman goes into early labor, her obstetrician may give her drugs to quiet the woman's uterus and prevent premature birth.
New research shows, however, that one popular drug works no better than a placebo at maintaining pregnancy after the initial bout of preterm labor is halted, say scientists at the Stanford University School of Medicine, Lucile Packard Children's Hospital and Santa Clara Valley Medical Center. The new trial is the first-ever placebo-controlled test of nifedipine, a muscle relaxant originally developed to lower blood pressure, and its effect on premature delivery with prolonged treatment. The findings were published in the December issue of the journal Obstetrics and Gynecology.Source/Read More...
NATION GETS A “D” AS MARCH OF DIMES RELEASES PREMATURE BIRTH REPORT CARD
In the first of what will be an annual Premature Birth Report Card, the nation received a “D” and not a single state earned an “A,” when the March of Dimes compared actual preterm birth rates to the national Healthy People 2010 objective.
In addition to providing state rankings, the March of Dimes Premature Birth Report Card analyzes several contributing factors and prevention opportunities, including rates of late preterm birth, smoking, and uninsured women of childbearing age. The purpose is to raise public awareness of the growing crisis of preterm birth so elected and appointed officials will commit more resources to address this problem and policymakers will support development of strategies that benefit mothers and babies.
MOTHERS LAUNCH NATIONAL PETITION FOR PREEMIES
Mothers are casting their votes for healthy babies and asking all Americans to join them in signing the March of Dimes 2008 Petition for Preemies. They’re putting public officials, and all Americans, on notice that it’s time to focus on the growing problem of premature birth, the leading cause of newborn death.
by Glade B. Curtis and Judith Schuler
by Barbara Luke and Tamara Eberlein