Does progesterone prophylaxis to prevent preterm labour improve outcome? - a randomised double blind placebo controlled trial (OPPTIMUM) - OPPTIMUM

Phase 1

• Conditions: Preterm labour; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2007-007950-77-SE
• Lead Sponsor: niversity of Edinburgh and NHS Lothian Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-03
• Study Completion: 2015-12-31
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1228

Inclusion Criteria

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. 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

Exclusion Criteria

Known significant structural or chromosomal fetal anomaly; known sensitivity, contraindication or intolerance to progesterone (including peanut allergy); 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