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

Overview 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 health. it involved 1197 women at high risk of preterm labour and compared a daily dose of 200 mg progesterone administered by vaginal pessary from 22 to 34 weeks’ gestation with placebo. pregnant women were deemed at risk of a preterm labour if they had a history in a previous pregnancy of either preterm birth, second-trimester loss, preterm premature rupture of the foetal membranes, a short cervical length (≤25 mm) at 18 to 24 weeks gestation or any cervical procedure to treat an abnormal smear. Women were recruited from 65 antenatal clinics in the uK and 1 in sweden. Progesterone treatment had no effect compared with placebo on the obstetric outcomes (foetal death or delivery before 34 weeks’ gestation), neonatal outcomes (a composite of death, brain injury on ultrasound scan and bronchopulmonary dysplasia) or childhood outcomes (the Bayley-iii cognitive composite score at 22–26 months of age). There was no difference in the rate of death or delivery before 34 weeks in the treatment group compared with placebo (Or 0.86, 95% ci 0.61 to 1.22) and no difference in neonatal death, brain injury or chronic lung disease (Or 0.62, 95% CI 0.38 to 1.03). The mean difference in the Bayley-iii cognitive composite score between treatment groups was –0.48 (95% ci –2.77 to 1.81) suggesting no difference in this outcome with progesterone either. (The study was funded by the Medical research council, national institute for health research.)