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17-hydroxyprogesterone caproate for preterm rupture of the membranes: a multicenter, randomized, double-blind, placebo-controlled trial.
Am J Obstet Gynecol. 2015 Sep; 213(3):364.e1-12.AJ

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.

Authors+Show Affiliations

Center for Research, Education, and Quality, Obstetrix, Mednax National Medical Group, Sunrise, FL; Obstetrix Medical Group, San Jose, CA. Electronic address: andrewcombs@me.com.Center for Research, Education, and Quality, Obstetrix, Mednax National Medical Group, Sunrise, FL; Department of Obstetrics and Gynecology, University of California, Irvine, School of Medicine, Irvine, CA.Center for Research, Education, and Quality, Obstetrix, Mednax National Medical Group, Sunrise, FL.Center for Research, Education, and Quality, Obstetrix, Mednax National Medical Group, Sunrise, FL.Biometrics, San Francisco, CA.Obstetrix Medical Group, Phoenix Perinatal Associates, Phoenix, AZ.Obstetrix Medical Group, Denver, CO.Norton Healthcare, Louisville, KY.High Risk Pregnancy Center, Las Vegas, NV.Department of Obstetrics and Gynecology, University of South Alabama School of Medicine, Mobile, AL.Obstetrix Medical Group, Kansas City, MO.Obstetrix Medical Group, Tucson, AZ.Obstetrix Medical Group, Long Beach, CA.Obstetrix Medical Group, Denver, CO.Spectrum Health, Grand Rapids, MI.Obstetrix Medical Group, Seattle, WA.No affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25979614

Citation

Combs, C Andrew, et al. "17-hydroxyprogesterone Caproate for Preterm Rupture of the Membranes: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial." American Journal of Obstetrics and Gynecology, vol. 213, no. 3, 2015, pp. 364.e1-12.
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(3):364.e1-12.
Combs, C. A., Garite, T. J., Maurel, K., Abril, D., Das, A., Clewell, W., Heyborne, K., How, H., Huang, W., Lewis, D., Lu, G., Miller, H., Nageotte, M., Porreco, R., Sheikh, A., & Tran, L. (2015). 17-hydroxyprogesterone caproate for preterm rupture of the membranes: a multicenter, randomized, double-blind, placebo-controlled trial. American Journal of Obstetrics and Gynecology, 213(3), e1-12. https://doi.org/10.1016/j.ajog.2015.05.009
Combs CA, 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(3):364.e1-12. PubMed PMID: 25979614.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 17-hydroxyprogesterone caproate for preterm rupture of the membranes: a multicenter, randomized, double-blind, placebo-controlled trial. AU - Combs,C Andrew, AU - Garite,Thomas J, AU - Maurel,Kimberly, AU - Abril,Diana, AU - Das,Anita, AU - Clewell,William, AU - Heyborne,Kent, AU - How,Helen, AU - Huang,Wilson, AU - Lewis,David, AU - Lu,George, AU - Miller,Hugh, AU - Nageotte,Michael, AU - Porreco,Richard, AU - Sheikh,Asad, AU - Tran,Lan, AU - ,, Y1 - 2015/05/13/ PY - 2015/03/13/received PY - 2015/05/05/accepted PY - 2015/5/17/entrez PY - 2015/5/17/pubmed PY - 2015/11/17/medline KW - 17-hydroxyprogesterone caproate KW - preterm rupture of membranes KW - prevention of preterm birth SP - 364.e1 EP - 12 JF - American journal of obstetrics and gynecology JO - Am J Obstet Gynecol VL - 213 IS - 3 N2 - 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. SN - 1097-6868 UR - https://www.unboundmedicine.com/medline/citation/25979614/17_hydroxyprogesterone_caproate_for_preterm_rupture_of_the_membranes:_a_multicenter_randomized_double_blind_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9378(15)00458-5 DB - PRIME DP - Unbound Medicine ER -