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Vaginal progesterone prophylaxis for preterm birth (the OPPTIMUM study): a multicentre, randomised, double-blind trial.
Norman JE et al.
Editor's comment: Prof. Jim Thornton: OPPTIMUM - progesterone ineffective for high risk of preterm labour
The main report of the OPPTIMUM trial of vaginal progesterone to prevent preterm birth in high risk pregnancy is in the February Lancet. Progesterone had no significant effect on the primary obstetric outcome, fetal death or birth before 34 weeks (odds ratio [OR] 0·86, 95% CI 0·61-1·22) or neonatal outcome, a composite of death, brain injury, or bronchopulmonary dysplasia (OR 0·62, 0·38-1·03), nor on the childhood outcome (cognitive score, progesterone group vs placebo group, 97·3 [SD 17·9] vs 97·7 [17·5]; difference in means -0·48, 95% CI -2·77 to 1·81). By two years the rate of death or moderate-to-severe neurodevelopmental impairment, a secondary outcome, favoured placebo, OR 1·45 (95% CI 0·98 to 2·15).