NCT00329914

Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies?

Effectiveness of Vaginally Administered Progesterone to Prevent Preterm Delivery in Twin Pregnancies - A Multicentre Randomized Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 677 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether a daily dose of 200 mg progesterone administered vaginally from 20-23 to 34 weeks' gestation will reduce the rate of preterm delivery amongst twin pregnancies.

Detailed description

Multiple gestations account for 2% of all pregnancies, but cause more than 10% of the cases of preterm delivery. Due to increasing maternal age and use of assisted reproduction the number of multiple gestations is larger than ever. If markers of preterm delivery can be identified and means of preventing preterm delivery are found, it will be possible to reduce the number of children admitted to hospital because of prematurity. Recently, two larger randomised studies investigated the effect of progesterone in singleton pregnancies of women who had previously delivered preterm. They both found a significant reduction in the preterm delivery rate in the progesterone group compared to a placebo group. The study will be performed as a randomized, double-blind placebo controlled study of twin pregnancies in Denmark and Austria. The women will be randomised in a 1:1 ratio to two groups (progesterone versus placebo). Randomisation will be stratified per centre and according to chorionicity, as the risk of preterm delivery is doubled in monochorionic twins compared to dichorionic twins.

Conditions

• Preterm Delivery

Interventions

Type	Name	Description
DRUG	Progesterone	Vaginal pessaries, 200 mg/day
DRUG	Placebo	Placebo pessaries containing peanut oil

Timeline

• Start date: 2006-06-01
• Primary completion: 2009-02-01
• Completion: 2010-09-01
• First posted: 2006-05-25
• Last updated: 2011-07-25

Locations

17 sites across 2 countries: Austria, Denmark