Does progesterone prophylaxis to prevent preterm labour improve outcome?: a randomised, double-blind, placebo-controlled trial

niversity of Edinburgh (UK)0 个研究点目标入组 1,125 人开始时间: 2008年11月21日最近更新: 2018年7月16日

适应症

试验速览

•Screening Study:
•High risk for preterm birth as indicated by at least one of the following:
•1. History of previous preterm birth (PTB)/second trimester loss
•2. Previous preterm premature rupture of the foetal membranes
•3. Short cervical length (<25 mm) on ultrasound at 18-22 weeks gestation
•4. All women will have gestation established by scan at ¡Ü 16 weeks to ensure that the estimated date of delivery is accurate
•5. Signed consent form
•Main Study:
•All women fulfilling the above inclusion criteria and who have a positive screening (fFN) test at 22 weeks will be eligible for the main (treatment) phase of the study. Further consent must be obtained.

•1. Known significant structural or chromosomal foetal anomaly
•2. Known sensitivity, contraindication or intolerance to progesterone (including peanut allergy)
•3. Suspected or proven rupture of the foetal membranes at the time of recruitment
•4. Multiple pregnancy
•5. Prescription or ingestion of medications known to interact with progesterone (e.g., ketoconazole and ciclosporin)

发起方

niversity of Edinburgh (UK)