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

Not Applicable

Completed

• Conditions: Preterm labour; Pregnancy and Childbirth

• Registration Number: ISRCTN14568373
• Lead Sponsor: niversity of Edinburgh (UK)

Brief Summary

2010 questionnaire results in: http://www.ncbi.nlm.nih.gov/pubmed/21122602 2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22866909 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26921136 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29945711

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-21
• Study Completion: 2015-12-31
• Last Update Posted: 16 July 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1125

Inclusion Criteria

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.

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Primary obstetric outcome of the treatment phase is delivery <34 weeks of gestation (Yes/No)<br>2. Primary neonatal outcome is a composite of death or two markers of neonatal morbidity <br>3. Primary childhood outcome is developmental status at two years<br>4. Formal economic evaluation