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Single dose 17 alpha-hydroxyprogesterone caproate in preterm labor: a randomized trial.

Peng Chiong Tan¹, Anthonia Siaw Jia King, Narayanan Vallikkannu

¹Department of Obstetrics and Gynecology, University of Malaya, 50603 Lembah Pantai, Kuala Lumpur, Malaysia. pctan@um.edu.my

Archives of Gynecology and Obstetrics

|July 29, 2011

Summary

A single dose of 17 alpha-hydroxyprogesterone caproate (17-OHPC) did not delay delivery when used with nifedipine tocolysis for preterm labor. This study found no significant difference in delivery rates between the 17-OHPC and placebo groups.

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Area of Science:

Obstetrics and Gynecology
Maternal-Fetal Medicine
Pharmacology

Background:

Preterm labor is a significant concern in maternal-fetal medicine, associated with increased neonatal morbidity and mortality.
Nifedipine is commonly used for tocolysis to delay preterm birth, but its efficacy can be limited.
17 alpha-hydroxyprogesterone caproate (17-OHPC) is a progestin with potential tocolytic properties.

Purpose of the Study:

To investigate the efficacy of a single 250-mg intramuscular dose of 17-OHPC as an adjunct to nifedipine tocolysis in women with threatened preterm labor.
To determine if 17-OHPC can further delay delivery when combined with standard tocolytic therapy.

Main Methods:

A double-blind, randomized placebo-controlled trial was conducted.
Participants (22-35 weeks' gestation) with threatened preterm labor received nifedipine tocolysis and antenatal corticosteroids.
They were randomized to receive either a single 250-mg intramuscular injection of 17-OHPC or a placebo saline injection.

Main Results:

Delivery rates within 48 hours were 20.4% for the 17-OHPC group and 26.8% for the placebo group (RR 0.76; 95% CI 0.38-1.51).
Delivery rates within 7 days were 25.0% for the 17-OHPC group and 35.2% for the placebo group (RR 0.71; 95% CI 0.39-1.29).
No significant differences were observed in delivery timing, gestational age at delivery, or neonatal outcomes between the groups.

Conclusions:

A single adjunctive dose of 17-OHPC did not demonstrate a significant benefit in delaying delivery for threatened preterm labor when used with nifedipine.
Further research may be needed to explore different dosing regimens or combinations of 17-OHPC for preterm labor management.