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

早产是英国出生婴儿死亡和残疾的最大单一原因。目前，没有药物治疗已被证明可以通过预防早产的发生来改善婴儿的结局。最近有研究表明，一种名为孕酮的天然激素可以将早产的风险降低约50%。在拟议的研究中，我们将证实或反驳这种对早产的影响，更重要的是确定它是否改善了婴儿和儿童的结局。同意参加研究的早产高风险孕妇将在妊娠22-24周至34周期间每天接受黄体酮或安慰剂（模拟）阴道栓。我们将记录妇女何时分娩，婴儿是否存活，如果存活，则使用发育评估量表记录其立即健康状况（包括任何脑损伤或肺部疾病）和两岁时的健康状况。我们还将计算NHS治疗的费用。我们希望证明黄体酮治疗可以降低早产的风险，改善婴儿的即时健康，与儿童2岁时思维能力的提高有关，并降低NHS的整体成本。

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.