17-hydroxyprogesterone caproate for preterm rupture of the membranes: a multicenter, randomized, double-blind, placebo-controlled trial - 31/08/15

Doi : 10.1016/j.ajog.2015.05.009

C. Andrew Combs, MD, PhD ^a,^b,^⁎ , Thomas J. Garite, MD ^a,^c, Kimberly Maurel, RN, MSN, CNS ^a, Diana Abril, RN, MSCRM ^a, Anita Das, PhD ^d, William Clewell, MD ^f, Kent Heyborne, MD ^g, Helen How, MD ^h, Wilson Huang, MD ⁱ, David Lewis, MD ^j, George Lu, MD ^k, Hugh Miller, MD ^l, Michael Nageotte, MD ^e, Richard Porreco, MD ^g, Asad Sheikh, MD ^m, Lan Tran, MD ⁿ
for the
Obstetrix Collaborative Research Network
Brian Mercer, MD, Michael Gravett, MD, Reese Clark, MD, Barbara Marusiak, DHsc, David Lewis, MD, Casey Armistead, BSRN, William Clewell, MD, Ana Braecsu, RN, MSN, MPH, Michelle Gamez, RN, BSN, Gloria Mullen, RN, Richard Porreco, MD, Kent Heyborne, MD, Jeri Lech, RN, Julie Rael, RN, C. Andrew Combs, MD, Kimberly Mallory, RN, BSN, Hugh Miller, MD, Diane Mercer, RN, Nadema Jones, CCRP, Michael Nageotte, MD, Deysi Caballero, LVN, Donna Guizado, RN, Asad Sheikh, MD, Alison Dutkiewicz, RN, Judy Hancock, RN, Yvonne Edgerly, RN, Lori Oosterman, RN, Mary Readwin, RN, Lan Tran, MD, Dawn Artis, RN, BSN, Tina Lopez, RN, Helen How, MD, Christina Waldon, RN, Kimberly Pruit, RN, Wilson Huang, MD, Judy Hancock, MSN, George Lu, MD, Kate Swearingen, MSN, APRNc, Anita Das, PhD, Thomas J. Garite, MD, C. Andrew Combs, MD, PhD, Kimberly Maurel, RN, MSN, CNS, Diana Abril, RN, BSN, CRM

^a Center for Research, Education, and Quality, Obstetrix, Mednax National Medical Group, Sunrise, FL
^b Obstetrix Medical Group, San Jose, CA
^c Department of Obstetrics and Gynecology, University of California, Irvine, School of Medicine, Irvine, CA
^d Biometrics, San Francisco, CA
^e Obstetrix Medical Group, Long Beach, CA
^f Obstetrix Medical Group, Phoenix Perinatal Associates, Phoenix, AZ
^g Obstetrix Medical Group, Denver, CO
^h Norton Healthcare, Louisville, KY
ⁱ High Risk Pregnancy Center, Las Vegas, NV
^j Department of Obstetrics and Gynecology, University of South Alabama School of Medicine, Mobile, AL
^k Obstetrix Medical Group, Kansas City, MO
^l Obstetrix Medical Group, Tucson, AZ
^m Spectrum Health, Grand Rapids, MI
ⁿ Obstetrix Medical Group, Seattle, WA

^∗Corresponding author: C. Andrew Combs MD, PhD.

Abstract

Objective

Preterm rupture of membranes (PROM) is associated with an increased risk of preterm birth and neonatal morbidity. Prophylactic 17-hydroxyprogesterone caproate (17OHP-C) reduces the risk of preterm birth in some women who are at risk for preterm birth. We sought to test whether 17OHP-C would prolong pregnancy or improve perinatal outcome when given to mothers with preterm rupture of the membranes.

Study Design

This is a multicenter, double-blind, placebo-controlled, randomized clinical trial. The study included singleton pregnancies with gestational ages from 23^0/7 to 30^6/7 weeks at enrollment, documented PROM, and no contraindication to expectant management. Consenting women were assigned randomly to receive weekly intramuscular injections of 17OHP-C (250 mg) or placebo. The primary outcome was continuation of pregnancy until a favorable gestational age, which was defined as either 34^0/7 weeks of gestation or documentation of fetal lung maturity at 32^0/7 to 33^6/7 weeks of gestation. The 2 prespecified secondary outcomes were interval from randomization to delivery and composite adverse perinatal outcome. The planned sample size was 222 total women.

Results

From October 2011 to April 2014, 152 women were enrolled; 74 women were allocated randomly to 17OHP-C, and 78 were allocated randomly to placebo. The trial was stopped when results of a planned interim analysis suggested that continuation was futile. The primary outcome was achieved in 3% of the 17OHP-C group and 8% of the placebo group (P = .18). There was no significant between-group difference in the prespecified secondary outcomes, randomization-to-delivery interval (17.1 ± 16.1 vs 17.0 ± 15.8 days, respectively; P = .76) or composite adverse perinatal outcome (63% vs 61%, respectively; P = .93). No significant differences were found in other outcomes, which included rates of chorioamnionitis, postpartum endometritis, cesarean delivery, individual components of the composite outcome, or prolonged neonatal length of stay.

Conclusion

Compared with placebo, weekly 17OHP-C injections did not prolong pregnancy or reduce perinatal morbidity in patients with PROM in this trial.

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Key words : 17-hydroxyprogesterone caproate, preterm rupture of membranes, prevention of preterm birth

Plan

Methods

Inclusion/exclusion criteria

	Additional members of the Obstetrix Collaborative Research Network who participated in this trial are listed in the Acknowledgments.
	Sponsored and funded by the Center for Research, Education, and Quality, Mednax National Medical Group, Sunrise, FL.
	All authors, except Drs Das, How, Huang, Lewis, and Sheikh, are employees of Obstetrix Medical Group, a subsidiary of Mednax. KV Pharmaceutical (now Lumara Health, Chesterfield, MO) donated the Makena hydroxyprogesterone caproate and placebo for this trial through an unrestricted grant and had no involvement in the design or conduct of the trial or in the writing or decision to submit the article. The authors report no conflict of interest.
	Cite this article as: Combs CA, Garite TJ, Maurel K, et al. 17-hydroxyprogesterone caproate for preterm rupture of the membranes: a multicenter, randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol 2015;213:364.e1-12.

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Vol 213 - N° 3

P. 364.e1-364.e12 - septembre 2015 Retour au numéro

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17-hydroxyprogesterone caproate for preterm rupture of the membranes: a multicenter, randomized, double-blind, placebo-controlled trial - 31/08/15

Abstract

Objective

Study Design

Results

Conclusion

Plan

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