Open Access Research article

17-Hydroxyprogesterone caproate to prolong pregnancy after preterm rupture of the membranes: early termination of a double-blind, randomized clinical trial

C Andrew Combs18*, Thomas J Garite2, Kimberly Maurel3, Kimberly Mallory1, Rodney K Edwards4, George Lu5, Richard Porreco6, Anita Das7 and the Obstetrix Collaborative Research Network

Author Affiliations

1 Obstetrix Medical Group, Center for Research, Quality, and Education, San Jose, CA, USA

2 Obstetrix Medical Group, Center for Research, Quality, and Education, Steamboat Springs, CO, USA

3 Obstetrix Medical Group, Center for Research, Quality, and Education, Fountain Valley, CA, USA

4 Obstetrix Medical Group, Phoenix Perinatal Associates, Phoenix, AZ, USA

5 Obstetrix Medical Group of Kansas City, Kansas City, MO, USA

6 Obstetrix Medical Group of Colorado, Denver, CO, USA

7 AxiStat, Inc., San Francisco, CA, USA

8 Obstetrix Medical Group, 900 E Hamilton Avenue #220, Campbell, CA, USA

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BMC Research Notes 2011, 4:568  doi:10.1186/1756-0500-4-568

Published: 29 December 2011

Abstract

Background

Progestational agents may reduce the risk of preterm birth in women with various risk factors. We sought to test the hypothesis that a weekly dose of 17-hydroxyprogesterone caproate (17P) given to women with preterm rupture of the membranes (PROM) will prolong pregnancy and thereby reduce neonatal morbidity.

Methods

Double-blind, placebo-controlled randomized clinical trial. Women with PROM at 23.0 to 31.9 weeks of gestation were randomly assigned to receive a weekly intramuscular injection of 17P (250 mg in 1 mL castor oil) or placebo (1 mL castor oil). The primary outcome was the rate of continuing the pregnancy until 34.0 weeks of gestation or until documentation of fetal lung maturity at 32.0 to 33.9 weeks of gestation. Planned secondary outcomes were duration of latency period and rate of composite neonatal morbidity. Enrollment of 111 participants per group, 222 total, was planned to yield 80% power to detect an increase in the primary outcome from 30% with placebo to 50% with 17P.

Results

Twelve women were enrolled of whom 4 were randomly assigned to receive 17P and 8 to receive placebo. The trial was terminated prematurely because of two separate issues related to the supply of 17P. No adverse events attributable to 17P were identified.

Conclusion

Because of premature termination, the trial does not have adequate statistical power to evaluate efficacy or safety of 17P in women with PROM. Nonetheless, ethical principles dictate that we report the results, which may contribute to possible future metaanalyses and systematic reviews.

Trial Registration

ClinicalTrials.gov: NCT01119963

Supported by a research grant from the Center for Research, Education, and Quality, Pediatrix Medical Group, Sunrise, FL