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#Grand Rounds

Do Progestogens Prevent Preterm Birth in Symptomatic Pregnancies with a Short Cervix?

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BACKGROUND AND PURPOSE:

  • Vaginal progesterone reduces risk of preterm birth in asymptomatic women with short cervix
  • Studies in symptomatic women and short cervix are inconclusive
  • Facchinetti et al. (Obstetrics & Gynecology) analyzed the efficacy of progestogens as a tocolytic agent in women with a short cervix

METHODS:

  • Randomized Controlled Trial (RCT)
    • Singleton pregnancies between 22 weeks 0 days and 31 weeks and 6 days gestation
    • Arrested preterm labor with a cervix ≤ 25 mm
    • Previous preterm birth excluded
  • Participants received one of the following:
    • Vaginal micronized progesterone (200 mg per day)
    • Intramuscular 17[alpha]-hydroxyprogesterone caproate (17-OHPC) (341 mg per week)
    • No treatment (control group)
  • Primary Outcome
    • Proportion of women with preterm birth < 37 week of gestation

RESULTS:

  • 254 women randomized and 235 women remained for analysis
  • Preterm birth rate did not differ significantly between groups:
    • 23% in the 17-OHPC
    • 39% in the vaginal progesterone group
    • 22% in the control group
  • Trial stopped during interim analysis (after 50% enrollment) due to futility (nonstatistical increase in preterm birth in vaginal progesterone group and difference even if study continued unlikely to show difference)

CONCLUSION:

  • Data in this study contradict previous study by this team
    • Possible explanations include weekly rather than 2x/week
    • More stringent study criteria in this study
      • Exclusion of prior preterm birth and 17-OHPC known to prevent subsequent preterm birth
      • Rigorous and not subjective diagnosis of short cervix
    • Possible that 17-OHPC could still be useful in very high risk (cervix < 15 mm)
  • Progestogen use in symptomatic women with a short cervix does not reduce risk for preterm birth once the cervix is ≤ 25 mm

Learn More – Primary Sources:

Progestogens for Maintenance Tocolysis in Women With a Short Cervix: A Randomized Controlled Trial

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Related ObG Topics:

17-OHPC Treatment and Prevention of Preterm Birth: Does Timing Matter?
What Is the Quality of Compounded 17-OHPC In US Pharmacies?
SMFM Statement: Choice of Progestogen for Preterm Birth Prevention

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