17 alpha-hydroxyprogesterone caproate to prevent prematurity in nulliparas with cervical length less than 30 mm

Am J Obstet Gynecol. 2012 Nov;207(5):390.e1-8. doi: 10.1016/j.ajog.2012.09.013. Epub 2012 Sep 17.

Abstract

Objective: We sought to evaluate whether 17 alpha-hydroxyprogesterone caproate (17-OHP) reduces preterm birth (PTB) in nulliparous women with a midtrimester cervical length (CL) <30 mm.

Study design: In this multicenter randomized controlled trial, nulliparous women with a singleton gestation between 16 and 22 3/7 weeks with an endovaginal CL <30 mm (<10th percentile in this population) were randomized to weekly intramuscular 17-OHP (250 mg) or placebo through 36 weeks. The primary outcome was PTB <37 weeks.

Results: The frequency of PTB did not differ between the 17-OHP (n = 327) and placebo (n = 330) groups (25.1% vs 24.2%; relative risk, 1.03; 95% confidence interval, 0.79-1.35). There also was no difference in the composite adverse neonatal outcome (7.0% vs 9.1%; relative risk, 0.77; 95% confidence interval, 0.46-1.30).

Conclusion: Weekly 17-OHP does not reduce the frequency of PTB in nulliparous women with a midtrimester CL <30 mm.

Trial registration: ClinicalTrials.gov NCT00439374.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • 17 alpha-Hydroxyprogesterone Caproate
  • Adolescent
  • Adult
  • Cervical Length Measurement / drug effects*
  • Female
  • Humans
  • Hydroxyprogesterones / therapeutic use*
  • Infant, Newborn
  • Infant, Premature
  • Parity / drug effects*
  • Pregnancy
  • Pregnancy Outcome
  • Premature Birth / prevention & control*
  • Progestins / therapeutic use*
  • Treatment Outcome
  • Young Adult

Substances

  • Hydroxyprogesterones
  • Progestins
  • 17 alpha-Hydroxyprogesterone Caproate

Associated data

  • ClinicalTrials.gov/NCT00439374

Grant support