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

March of Dimes Award abstract

Society for Maternal-Fetal Medicine

This press release is available in French.

In a study to be presented on February 14 between 8 a.m. and 10 a.m. PST, at the Society for Maternal-Fetal Medicine's 33rd annual meeting, The Pregnancy Meeting ™, researchers will report findings that suggest that 17P, a form of progesterone, is not effective in preventing preterm birth among women with twin pregnancies -- and may possibly be harmful.

While 17P (17 alpha-hydroxyprogesterone caproate) has been shown to prevent premature delivery among about one-third of women with a singleton pregnancy who have experienced a prior preterm delivery, this latest research shows that 17P prescriptions can't do the same for moms having twins, the authors say.

"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 reported in the abstract, entitled: Prevention of preterm delivery by 17 alpha-hydroxyprogesterone caproate in asymptomatic twin pregnancies with a short cervix: a randomized controlled trial, 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.

"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."

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.

Dr. McCabe will present Dr. Deruelle with the March of Dimes award for Best Abstract in Prematurity at the SMFM's Annual Meeting. 2013 marks the 10th year the March of Dimes award has been presented.

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In addition to Dr. Deruelle, the study was conducted by Marie Victoire Senat, Hopital Bicêtre, Hopital Antoine Béclère, APHP, Paris Sud, Faculté de Medecine Paris XI, Department of Obstetrics and Gynecology in Clamart, France; Norbert Winer, Hôpital Mère-Enfant, Department of Obstetrics and Gynecology in Nantes, France; and Patrick Rozenberg, Hôpital Poissy Saint-Germain, Department of Obstetrics and Gynecology in Poissy, France.

A copy of the abstract is available http://www.smfmnewsroom.org/wp-content/uploads/2013/01/1-8.pdf and below. For interviews please contact Vicki Bendure at Vicki@bendurepr.com, 202-374-9259 (cell), or Meghan Blackburn at Meghan@bendurepr.com, 540-687-5099 (office) or 859-492-6303 (cell).

The Society for Maternal-Fetal Medicine (est. 1977) is a non-profit membership group for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine. The society is devoted to reducing high-risk pregnancy complications by providing continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual scientific meeting in which new ideas and research in the area of maternal-fetal medicine are unveiled and discussed. For more information, visit www.smfm.org or www.facebook.com/SocietyforMaternalFetalMedicine.

In 2013, the March of Dimes celebrates its 75th Anniversary and its ongoing work to help babies get a healthy start in life. Early research led to the Salk and Sabin polio vaccines that all babies still receive. Other breakthroughs include new treatments for premature infants and children with birth defects. About 4 million babies are born each year in the United States, and all have benefitted from March of Dimes lifesaving research and education. The March of Dimes is the leading nonprofit organization for pregnancy and baby health. With chapters nationwide and its premier event, March for Babies®, the March of Dimes works to improve the health of babies by preventing birth defects, premature birth and infant mortality. For the latest resources and information, visit marchofdimes.com or nacersano.org.

Abstract 3: Prevention of preterm delivery by 17 alpha-hydroxyprogesterone caproate in asymptomatic twin pregnancies with a short cervix: a randomized controlled trial

Marie Victoire Senat 1, Philippe Deruelle 2, Norbert Winer 3, Patrick Rozenberg 4

1 Hopital Bicêtre, Hopital Antoine Béclère, APHP, Paris Sud, Faculté de Medecine Paris XI, Department of Obstetrics and Gynecology, Clamart, France; 2 Hôpital Jeanne de Flandre, CHU Lille, F-59000, EA2694, UDSL, Université Lille Nord de France, Department of Obstetrics and Gynecology, Lille, France; 3 Hôpital Mère-Enfant, Department of Obstetrics and Gynecology, Nantes, France; 4 Hôpital Poissy Saint-Germain, Department of Obstetrics and Gynecology, Poissy, France.

OBJECTIVE: To evaluate the use of 17 alpha-hydroxyprogesterone caproate (17P) to reduce the risk of preterm delivery in asymptomatic twin pregnancy with short cervix.

STUDY DESIGN: This open-label multicenter randomized controlled trial took place at 10 university hospitals between June 2006 and January 2010. Women older than 18 years and carrying twins were eligible between 24+0 through 31+6 weeks of gestation if they were asymptomatic, presented a cervical length less than 25 mm as measured by routine transvaginal ultrasound and provided a written informed consent. Women were randomly assigned in a 1:1 ratio to receive 500 mg of intramuscular 17P, and repeated twice a week until 36 weeks or preterm delivery, whichever occurred first, or to no treatment with 17P (control group). The primary outcome was time from randomization to delivery.

RESULTS: Maternal characteristics of the 82 women in the 17P group and the 83 women in the control group were similar. Outcome data were available for 161 of the 165 women (97.6%). The intent-to-treat analysis with censoring at last follow up showed no significant difference between the 17P and controls group in median [Q1-Q3] time to delivery (45 [26-62] and 51 [36-66] days, respectively; mean difference, ¬- 7; 95% CI, - 15; +1). Treatment with 17P was associated with a significantly increase in the rate of preterm deliveries before 32 weeks of gestation (29% vs 12%, p0.007), but not before 37 weeks of gestation (80% vs 77%, p=0.70) or 34 weeks of gestation (44%vs 28%, p=0.10). Median [Q1-Q3] birth weight did not differ between 17P and controls groups for twin 1 (2120 [1750-2471]g and 2215 [1982-2535] g, p=0,06) but differ significantly for twin 2 (2090 [1540-2425] and 2230 [1985-2535] g, p=0,027). There was a non-significant trend to an increase of neonatal morbidity in a 17P group.

CONCLUSION: 17P is ineffective in women with asymptomatic twins and short cervix for prevention of preterm delivery and possibly harmful.

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