Does progesterone prophylaxis to prevent preterm labour improve outcome? - a randomised double blind placebo controlled trial (OPPTIMUM) - OPPTIMUM
- Conditions
- Preterm labour
- Registration Number
- EUCTR2007-007950-77-GB
- Lead Sponsor
- niversity of Edinburgh and NHS Lothian Health Board
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 1228
High risk for PTB as indicated by: at least one of (i) history of previous PTB/ second trimester loss (ii) previous preterm premature rupture of the fetal membranes (iii) short cervical length (< 25mm) on ultrasound at 18 – 22 weeks gestation. Additionally all will have a positive fFN at 22weeks. All women will have gestation established by scan at =16 weeks.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Known significant structural or chromosomal fetal anomaly; known sensitivity, contraindication or intolerance to progesterone; suspected or proven rupture of the fetal membranes at the time of recruitment; multiple pregnancy; prescription or ingestion of medications known to interact with progesterone (eg ketoconazole and ciclosporin).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: In women at high risk of preterm labour, does prophylactic vaginal natural progesterone, 200mg daily from 22 – 34 weeks gestation, compared to placebo:<br>i.Improve obstetric outcome by lengthening pregnancy and thus reducing the incidence of preterm delivery (before 34 weeks gestation)?<br>ii.Improve neonatal outcome by reducing a composite of death and major morbidity?<br>iii.Lead to improved childhood cognitive and neurosensory outcomes at two years?<br>iv.Represent cost effective management for women at high risk of preterm delivery?<br>;Secondary Objective: None;Primary end point(s): •Obstetric:Delivery before 34+0 completed weeks of gestation based on ultrasound.<br>•Neonatal: Composite outcome of death, brain injury or severe chronic lung disease [61].<br>•Early childhood: The Bayley III cognitive scale standardised score [62] at two years of chronological age <br>
- Secondary Outcome Measures
Name Time Method