Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies?

July 22, 2011 updated by: Rigshospitalet, Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

677

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Graz University Hospital
      • Innsbruck, Austria, 6020
        • Innsbruck University Hospital
      • Klagenfurt, Austria, 9020
        • Klagenfurt Hospital
      • Vienna, Austria, 1090
        • Vienna University Hospital
  • Denmark
      • Aalborg, Denmark, 9100
        • Aalborg Hospital
      • Aarhus, Denmark, 8200
        • Skejby Hospital
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
      • Glostrup, Denmark, 2600
        • Glostrup Hospital
      • Hellerup, Denmark, 2900
        • Gentofte Hospital
      • Herlev, Denmark, 2730
        • Herlev Hospital
      • Hilleroed, Denmark, 3400
        • Hilleroed Hospital
      • Holbaek, Denmark, 4300
        • Holbaek Hospital
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital
      • Odense, Denmark, 5000
        • Odense University Hospital
      • Roskilde, Denmark, 4000
        • Roskilde Hospital
      • Soenderborg, Denmark, 6400
        • Soenderborg Hospital
      • Viborg, Denmark, 8800
        • Viborg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo pessaries containing peanut oil
ACTIVE_COMPARATOR: Progesterone
Drug: Progesterone
Vaginal pessaries, 200 mg/day
Other Names:
  • Utrogestan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of delivery < 34 weeks, in the study group versus the control group
Time Frame: Participants will be followed until 3 weeks after delivery
Participants will be followed until 3 weeks after delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Physical and neurological development of the children at 6 and 18 months
Time Frame: 2 years after delivery
2 years after delivery
The relationship between cervical length and prophylactic progesterone treatment
Time Frame: Participants will be followed until 3 weeks after delivery
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
Time Frame: Participants will be followed until 3 weeks after delivery
Participants will be followed until 3 weeks after delivery
Assessment of the potential anti-inflammatory effect of progesterone by cytokine-measurements
Time Frame: Participants will be followed until 3 weeks after delivery
Participants will be followed until 3 weeks after delivery
Assessment of the effect of progesterone on CRH-levels in twin pregnancies
Time Frame: Participants will be followed until 3 weeks after delivery
Participants will be followed until 3 weeks after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

The Danish Medical Research Council
AP Moeller Foundation
The Danish Medical Society in Copenhagen

Investigators

  • Principal Investigator: Line Rode, MD, Ultrasound Clinic 4002, Rigshospitalet
  • Study Director: Ann Tabor, professor, Ultrasound Clinic 4002, Rigshospitalet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (ACTUAL)

February 1, 2009

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

May 24, 2006

First Submitted That Met QC Criteria

May 24, 2006

First Posted (ESTIMATE)

May 25, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 25, 2011

Last Update Submitted That Met QC Criteria

July 22, 2011

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • predict2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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