Posts Tagged ‘17p’

Study shows progesterone shots do not reduce preterm delivery in twin pregnancies

Friday, February 22nd, 2013

While 17P, a form of progesterone, has been shown to prevent premature delivery among about one-third of women who are pregnant with a single baby and who have experienced a prior preterm delivery, the latest research shows that 17P prescriptions can’t do the same for moms having twins.

“Twins are very high risk for preterm delivery, in fact, 60 percent of twins are born too soon. We can’t assume that what works for singleton pregnancies will work with multiples such as twins or triplets,” says Edward R. B. McCabe, MD, PhD, March of Dimes senior vice president and medical director. “This research finding is valuable because it will guide the care of women with a multi-fetal pregnancy, and highlights the need to better understand how to prevent preterm births for multiples.”

“We found that 17P was not effective in women with twin pregnancies and a short cervix (defined as less than 25 mm between 24 and 32 weeks),” says Philippe Deruelle, MD, with the Department of Obstetrics and Gynecology at Hôpital Jeanne de Flandre, Université Lille 2, France, and one of the study’s authors. “We actually seemed to have found an increase in the rate of preterm delivery before 32 weeks in the treatment group when compared to the non-treatment group.”

For the study, Dr. Deruelle and his colleagues conducted their trial on 165 women over the age of 18 at 10 university hospitals between June 2006 and January 2010. Outcome data was available for 161 of the 165 (97.6%) women. (The study’s title is Prevention of preterm delivery by 17 alpha-hydroxyprogesterone caproate in asymptomatic twin pregnancies with a short cervix: a randomized controlled trial, and was presented at the Society for Maternal-Fetal Medicine’s 33rd annual meeting last week.)

Dr. Deruelle recommends that women who know they are pregnant with twins get an ultrasound to measure their cervical length, as this factor has shown to predict which women with twins are at higher risk for premature pregnancy.

Hopefully, future research will help to shed light on ways to prevent pretem births for women who are pregnant with multiples.

MOD responds to Ther-Rx

Friday, April 1st, 2011

In the past few weeks, there has been a torrent of concern over the availability of progesterone therapy for women hoping to prevent premature birth.  We have held discussions with physician groups, various organizations and the manufacturer of the drug.  Ther-Rx Corporation’s handling of the launch of Makena, and the initial list price, were extremely disappointing and unacceptable to the March of Dimes and the families we represent.  While Ther-Rx Corporation’s decision yesterday to reduce the list price of Makena to $690 and to expand patient financial assistance are steps in the right direction toward making an FDA-approved progesterone therapy product more widely available, it’s not enough.  The March of Dimes has decided to exercise our right to terminate our current contract and sever all professional relationships with Ther-Rx.

The March of Dimes will continue to explore all options for ensuring access to progesterone therapy for all medically eligible women. Access for women to treatment to prevent premature birth is and always has been our paramount concern. We hope that the controversy surrounding Makena has helped raise awareness that progesterone therapy is a safe and effective treatment for prevention of preterm birth and that more obstetricians will consider it for appropriate patients.

MOD demands prompt action

Thursday, March 24th, 2011

A letter from Dr. Jennifer Howse, March of Dimes President, to Greg Divis, President Ther-Rx Corporation regarding Makena.

March 23, 2011

Greg Divis, President
Ther-Rx Corporation
One Corporate Woods
Bridgeton, MO 63044

Dear Mr. Divis:
Thank you for your letter of March 17th.  I am pleased to learn that you are ‘listening carefully to stakeholder concerns about list price, patient access, and cost to payers’.  Thank you for considering additional steps to ensure that Makena is available to all eligible women, and for  convening stakeholders from the March of Dimes, the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and the Society for Maternal Fetal Medicine next week. 

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 commit-ment 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.  Thank you for your consideration of this critical matter.

Sincerely,
 
Jennifer L. Howse, PhD
President

FDA approval of 17P

Friday, February 4th, 2011

17p-injectionThe first-ever drug known to prevent some preterm births won market approval today from the Food and Drug Administration.

“For the first time, we have an FDA-approved treatment to offer women who have delivered a baby too soon, giving them hope that their next child will have a better chance at a healthy start in life,” said Alan Fleischman, MD, senior vice president and medical director of the March of Dimes. “Women who already have had a baby born prematurely should check with their health care provider to see if this treatment is appropriate for them. This treatment is not for everyone.”
 
The FDA approved hydroxyprogesterone caproate injection, commonly known as 17P, which is a synthetic form of a hormone produced during pregnancy. It will be marketed under the brand name Makena™ and given in weekly injections to pregnant women between 16 and 20 weeks gestation and continuing until 37 weeks gestation. The drug is approved for use by women pregnant with one baby and who already have a baby who was born before 37 weeks of pregnancy either because labor began on its own, without drugs or other methods, or because the membranes surrounding the baby ruptured too early.

Prior to today’s approval of Makena™, health care providers ordered prescriptions of 17P from compounding pharmacies; however, many eligible patients faced logistical and financial barriers to access. FDA approval means the drug now will be widely available only in specialty pharmacies and that there will be improved access of the drug through healthcare coverage.

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.

What is cervical insufficiency?

Monday, August 16th, 2010

Cervical insufficiency (sometimes called incompetent cervix) refers to a cervix that opens too early during pregnancy, usually without pain and contractions. This most often occurs in the second or early third trimester of pregnancy, resulting in late miscarriage or premature birth. A woman may be diagnosed with cervical insufficiency based largely on this history. There is no specific diagnostic test.

Medical experts don’t always know why cervical insufficiency occurs. Factors that may contribute include:
• Uterine defects: Women with certain uterine defects, such as bicornuate uterus (two cavities), are more likely to have cervical insufficiency than women without these defects.
• History of surgical procedures involving the cervix: These include LEEP (loop electrosurgical excision procedure), which is used to diagnose and treat abnormal cells found during a Pap test.
• Injuries during a previous birth.
• Short cervix: The shorter the cervix, the more likely the woman is to have cervical insufficiency. In some cases, a short cervix can be congenital.

Miscarriage and premature birth due to cervical insufficiency frequently happen again in another pregnancy. These problems can sometimes be prevented with a procedure called cerclage, in which the provider places a stitch in the cervix to keep it from opening too early. The provider removes the stitch when the woman is ready to give birth.

It is not always clear which women will benefit from cerclage. This is because there is no specific test for cervical insufficiency, and many women who have had a late miscarriage or early premature birth go on to have normal pregnancies without treatment. Some studies suggest that cerclage is most likely to be beneficial in women who have had three or more late miscarriages or premature births. In some cases, providers may monitor a woman suspected of having cervical insufficiency with repeated vaginal ultrasounds to see if her cervix is shortening or showing other signs that she may give birth soon. The provider may recommend cerclage if these changes occur.

Some women learn that they have a short cervix during a routine ultrasound. Most of these women do not end up having a premature birth. However, short cervix, especially a very short cervix (less than 15 millimeters), does increase her risk of premature birth. Studies suggest that treatment with the hormone progesterone (17P) may help reduce the risk of premature birth in women with a very short cervix. According to the American College of Obstetricians and Gynecologists (ACOG), progesterone treatment may be considered for these women. However, ACOG does not recommend routine cervical-length screening for low-risk women.

Thinking about pregnancy after premature birth?

Thursday, January 15th, 2009

Here are some questions that women who have had a premature baby often ask.

  • I’ve already had a premature birth. What can I do to help get my full nine months of pregnancy?
  • Why was my baby born too early?
  • Do I need to go to a special doctor for care?
  • Why are some women more likely than other women to have a premature baby?
  • What can I do about my risk factors?

Key Things to Remember

Click here to watch the video, Take Action: Learn the Signs of Preterm Labor