Abstract

(Lancet. 2016;387:2106–2116) In a Cochrane meta-analysis, the administration of vaginal progesterone or intramuscular 17α-hydroxyprogesterone caproate reduced preterm birth in women with a short cervix but had no effect on neonatal mortality. For women with a history of prior preterm birth, the meta-analysis found both preterm birth and neonatal mortality were decreased with this treatment. However, data on prolonged benefit of the therapy as well as effects on the child after the neonatal period are lacking. To this end, a double-blind randomized trial, OPPTIMUM (dOes Progesterone Prophylaxis To prevent preterm labour IMprove oUtcoMe?), was performed to determine the effect of vaginal progesterone prophylaxis on neonatal and childhood outcomes.

Highlights

  • Several studies have assessed either vaginal progesterone or intramuscular 17α-hydroxyprogesterone caproate for the prevention of preterm birth in asymptomatic women with singleton pregnancy at high risk of preterm birth

  • The Cochrane Library meta-analysis grouped women treated with any progestogen and reported on risk of preterm birth before 34 weeks review for women with a short cervix (RR 0·64, 95% CI 0·45–0·90), and on perinatal mortality (RR 0·74, 0·42–1·29) or neonatal death (RR 0·55, 0·26–1·13)

  • Regarding women with a previous preterm birth, the Cochrane Library reported that progestogens reduced the incidence of preterm birth (RR 0·31, 95% CI 0·14–0·69), and both perinatal mortality (RR 0·50, 0·33–0·75) and neonatal death (RR 0·45, 0·27–0·76)

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Summary

Introduction

Several studies have assessed either vaginal progesterone or intramuscular 17α-hydroxyprogesterone caproate for the prevention of preterm birth in asymptomatic women with singleton pregnancy at high risk of preterm birth. One individual patient data meta-analysis of women with a short cervix reported the effect of vaginal progesterone on the outcomes of preterm birth before 33 weeks (relative risk [RR] 0·58, 95% CI 0·42–0·80), and on a composite of neonatal mortality and morbidity (RR 0·57, 0·40–0·81). This individual patient data meta-analysis was restricted to women treated with vaginal progesterone. The Cochrane Library meta-analysis grouped women treated with any progestogen and reported on risk of preterm birth before 34 weeks review for women with a short cervix (RR 0·64, 95% CI 0·45–0·90), and on perinatal mortality (RR 0·74, 0·42–1·29) or neonatal death (RR 0·55, 0·26–1·13). Progesterone administration has been shown to reduce the risk of preterm birth and neonatal morbidity in women at high risk, but there is uncertainty about longer term effects on the child

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