NCT02304237

Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women

A Multicenter, Randomized, Open-label, Investigator Initiated Trial of Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Ewha Womans University Mokdong Hospital · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study is for compare the efficacy of two different regimens(vaginal vs intramuscular) of progesterone therapy in prevention of preterm birth in high risk pregnant women.

Detailed description

The objectives of this study is 1) To compare the efficacy of two different regimens of progesterone therapy in preventing preterm birth less than 37 weeks of gestation. 2) To compare the cost-benefit, adverse effects and patient preference of two different regimens of progesterone therapy. Design: Multi-center, randomized, open-label trial

Conditions

• Premature Birth

Interventions

Type	Name	Description
DRUG	Vaginal progesterone	micronized progesterone 200mg/day till 36 weeks 6 days of gestation or premature rupture of membranes
DRUG	Intramuscular progesterone	hydroxyprogesterone caproate 250mg/ml/week till 36 weeks 6 days of gestation or premature rupture of membranes

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-11-01
• Completion: 2016-12-01
• First posted: 2014-12-01
• Last updated: 2014-12-01