Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies?

This study has been completed.
Sponsor:
Collaborators:
The Danish Medical Research Council
The Danish Medical Society in Copenhagen
AP Moeller Foundation
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00329914
First received: May 24, 2006
Last updated: July 22, 2011
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Preterm Delivery
Drug: Progesterone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Vaginally Administered Progesterone to Prevent Preterm Delivery in Twin Pregnancies - A Multicentre Randomized Trial

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical and neurological development of the children at 6 and 18 months [ Time Frame: 2 years after delivery ] [ Designated as safety issue: Yes ]
  • The relationship between cervical length and prophylactic progesterone treatment [ Time Frame: Participants will be followed until 3 weeks after delivery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Assessment of the potential anti-inflammatory effect of progesterone by cytokine-measurements [ Time Frame: Participants will be followed until 3 weeks after delivery ] [ Designated as safety issue: No ]
  • Assessment of the effect of progesterone on CRH-levels in twin pregnancies [ Time Frame: Participants will be followed until 3 weeks after delivery ] [ Designated as safety issue: No ]

Enrollment: 677
Study Start Date: June 2006
Study Completion Date: September 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo pessaries containing peanut oil
Other Name: Placebo
Active Comparator: Progesterone Drug: Progesterone
Vaginal pessaries, 200 mg/day
Other Name: Utrogestan

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329914

Locations
Austria
Graz University Hospital
Graz, Austria, 8036
Innsbruck University Hospital
Innsbruck, Austria, 6020
Klagenfurt Hospital
Klagenfurt, Austria, 9020
Vienna University Hospital
Vienna, Austria, 1090
Denmark
Aalborg Hospital
Aalborg, Denmark, 9100
Skejby Hospital
Aarhus, Denmark, 8200
Rigshospitalet
Copenhagen, Denmark, 2100
Glostrup Hospital
Glostrup, Denmark, 2600
Gentofte Hospital
Hellerup, Denmark, 2900
Herlev Hospital
Herlev, Denmark, 2730
Hilleroed Hospital
Hilleroed, Denmark, 3400
Holbaek Hospital
Holbaek, Denmark, 4300
Hvidovre Hospital
Hvidovre, Denmark, 2650
Odense University Hospital
Odense, Denmark, 5000
Roskilde Hospital
Roskilde, Denmark, 4000
Soenderborg Hospital
Soenderborg, Denmark, 6400
Viborg Hospital
Viborg, Denmark, 8800
Sponsors and Collaborators
Rigshospitalet, Denmark
The Danish Medical Research Council
The Danish Medical Society in Copenhagen
AP Moeller Foundation
Investigators
Principal Investigator: Line Rode, MD Ultrasound Clinic 4002, Rigshospitalet
Study Director: Ann Tabor, professor Ultrasound Clinic 4002, Rigshospitalet
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Ann Tabor, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00329914     History of Changes
Other Study ID Numbers: predict2006
Study First Received: May 24, 2006
Last Updated: July 22, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:
Preterm delivery
Prevention
Twins
Progesterone

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014