Does progesterone prophylaxis to prevent preterm labour improve outcome? (OPPTIMUM)

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Preterm delivery is the biggest single cause of death and disability amongst babies born in the UK. At present, no drug treatment has been demonstrated to improve the outcome for babies by preventing the onset of preterm labour. It has recently been shown that a natural hormone called progesterone may reduce the risk of preterm delivery by around 50%. In the proposed study, we will confirm or refute this effect on preterm delivery and more importantly determine whether it improves the outcome for the baby and child. Pregnant women at high risk of preterm delivery who agree to take part will be given either a progesterone or a placebo (dummy) pessary daily from 22-24 until 34 weeks of pregnancy. We will record when the woman gives birth, whether the baby survives, and if so its immediate health (including any brain damage or lung disease) and health at two years of age using a developmental assessment scale. We will also calculate the costs of NHS treatment. We hope to show that progesterone treatment reduces the risk of preterm birth, that it improves baby’s immediate health, it is associated with improved thinking ability of the child at two years, and it reduces NHS costs overall.