Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies?

Phase 2

Completed

• Conditions: Preterm Delivery
• Interventions: Drug: Placebo; Drug: Progesterone

• Registration Number: NCT00329914
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Study Timeline

• Study First Submitted: 2006-05-24
• Study First Submitted QC: 2006-05-24
• Study First Posted: 2006-05-25
• Study Start: 2006-06
• Status Verified: 2009-02
• Primary Completion: 2009-02
• Study Completion: 2010-09
• Last Update Submitted: 2011-07-22
• Last Update Posted: 2011-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 677

Inclusion Criteria

• Twin pregnancy
• Informed consent
• 18-23 weeks' gestation
• Participants must be fluent in the language spoken in the respective centres

Exclusion Criteria

• Age < 18 years
• Known allergy to progesterone or peanuts
• Active thromboembolic disorders or a history of hormone-associated thromboembolic disorders
• Rupture of membranes at the time of inclusion
• Monoamniotic twins
• Pregnancies treated for or with signs of twin-to-twin transfusion syndrome at inclusion
• Multiple pregnancies reduced to twin pregnancies
• Known significant structural or chromosomal fetal abnormality
• Chorionicity not assessed before 15 weeks
• Known or suspected malignancy in genitals or breasts
• Known liver disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Progesterone	Progesterone	-

Primary Outcome Measures

Name	Time	Method
The incidence of delivery < 34 weeks, in the study group versus the control group	Participants will be followed until 3 weeks after delivery

Secondary Outcome Measures

Name	Time	Method
Physical and neurological development of the children at 6 and 18 months	2 years after delivery
The relationship between cervical length and prophylactic progesterone treatment	Participants will be followed until 3 weeks after delivery
Determination of proteomics and RNA in preterm delivery and term delivery and an evaluation of the effect of progesterone on proteomics and RNA	Participants will be followed until 3 weeks after delivery
Assessment of the potential anti-inflammatory effect of progesterone by cytokine-measurements	Participants will be followed until 3 weeks after delivery
Assessment of the effect of progesterone on CRH-levels in twin pregnancies	Participants will be followed until 3 weeks after delivery

Trial Locations

Locations (17)

Glostrup Hospital; 🇩🇰 Glostrup, Denmark

Holbaek Hospital; 🇩🇰 Holbaek, Denmark

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Roskilde Hospital; 🇩🇰 Roskilde, Denmark

Soenderborg Hospital; 🇩🇰 Soenderborg, Denmark

Graz University Hospital; 🇦🇹 Graz, Austria

Vienna University Hospital; 🇦🇹 Vienna, Austria

Innsbruck University Hospital; 🇦🇹 Innsbruck, Austria

Klagenfurt Hospital; 🇦🇹 Klagenfurt, Austria

Aalborg Hospital; 🇩🇰 Aalborg, Denmark

Gentofte Hospital; 🇩🇰 Hellerup, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Skejby Hospital; 🇩🇰 Aarhus, Denmark

Herlev Hospital; 🇩🇰 Herlev, Denmark

Hilleroed Hospital; 🇩🇰 Hilleroed, Denmark

Viborg Hospital; 🇩🇰 Viborg, Denmark