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Does prophylactic progesterone for women at high risk of preterm birth improve outcomes?

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Review of: Norman JE et al. Does progesterone prophylaxis to prevent preterm labour improve outcome? A randomised double-blind placebo-controlled trial (OPPTIMUM). Health Technology Assessment 2018;22(35).

Key learning points

  • Results from the OPPTIMUM study showed that a daily dose of 200 mg progesterone administered by vaginal pessary to women at high risk of preterm birth showed no statistically significant benefit or harms on outcomes.

  • The results conflict with evidence from systematic reviews that suggested that progesterone prevents preterm birth.

A randomised controlled trial designed to study the effect of progesterone on infant mortality and health showed no benefits in terms of preterm birth, neonatal mortality or morbidity, or cognitive function in infancy.1


The OPPTIMUM trial was a randomised controlled double-masked study that aimed to assess the long-term effects of using progesterone prophylaxis to prevent preterm birth (birth before 37 weeks’ gestation) on neonatal and childhood …

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  • Contributors DTB team.

  • Provenance and peer review Commissioned; internally peer reviewed.