Prevention of preterm birth in triplets using 17 alpha-hydroxyprogesterone caproate: a randomized controlled trial.

Abstract

OBJECTIVE:

To assess whether 17 alpha-hydroxyprogesterone caproate reduces the rate of preterm birth in women carrying triplets.

METHODS:

We performed this randomized, double-blinded, placebo-controlled trial in 14 centers. Healthy women with triplets were randomly assigned to weekly intramuscular injections of either 250 mg of 17 alpha-hydroxyprogesterone caproate or matching placebo, starting at 16-20 weeks and ending at delivery or 35 weeks of gestation. The primary study outcome was delivery or fetal loss before 35 weeks.

RESULTS:

One hundred thirty-four women were assigned, 71 to 17 alpha-hydroxyprogesterone caproate and 63 to placebo; none were lost to follow-up. Baseline demographic data were similar in the two groups. The proportion of women experiencing the primary outcome (a composite of delivery or fetal loss before 35 0/7 weeks) was similar in the two treatment groups: 83% of pregnancies in the 17 alpha-hydroxyprogesterone caproate group and 84% in the placebo group, relative risk 1.0, 95% confidence interval 0.9-1.1. The lack of benefit of 17 alpha-hydroxyprogesterone caproate was evident regardless of the conception method or whether a gestational age cutoff for delivery was set at 32 or 28 weeks.

CONCLUSION:

Treatment with 17 alpha-hydroxyprogesterone caproate did not reduce the rate of preterm birth in women with triplet gestations.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov, www.clinicaltrials.gov, NCT00099164

LEVEL OF EVIDENCE:

I.

• Authors: Steve N Caritis, Dwight J Rouse, Alan M Peaceman, Anthony Sciscione, Valerija Momirova, Catherine Y Spong, Jay D Iams, Ronald J Wapner, Michael Varner, Marshall Carpenter, Julie Lo, John Thorp, Brian M Mercer, Yoram Sorokin, Margaret Harper, Susan Ramin, Garland Anderson, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Maternal-Fetal Medicine Units Network (MFMU)
• Journal: Obstetrics and gynecology (Obstet Gynecol) Vol. 113 Issue 2 Pt 1 Pg. 285-92 (Feb 2009) ISSN: 0029-7844 [Print] United States
• PMID: 19155896 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)

Chemical References

• Hydroxyprogesterones
• Progestins
• 17 alpha-Hydroxyprogesterone Caproate

Topics

• 17 alpha-Hydroxyprogesterone Caproate
• Adult
• Female
• Humans
• Hydroxyprogesterones (administration & dosage)
• Injections, Intramuscular
• Pregnancy
• Premature Birth (prevention & control)
• Progestins (administration & dosage)
• Risk
• Treatment Failure
• Triplets