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Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00329914
Recruitment Status : Completed
First Posted : May 25, 2006
Last Update Posted : July 25, 2011
The Danish Medical Research Council
The Danish Medical Society in Copenhagen
AP Moeller Foundation
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Preterm Delivery Drug: Progesterone Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 677 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Vaginally Administered Progesterone to Prevent Preterm Delivery in Twin Pregnancies - A Multicentre Randomized Trial
Study Start Date : June 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo pessaries containing peanut oil

Active Comparator: Progesterone Drug: Progesterone
Vaginal pessaries, 200 mg/day
Other Name: Utrogestan

Primary Outcome Measures :
  1. 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00329914

Show Show 17 study locations
Sponsors and Collaborators
Rigshospitalet, Denmark
The Danish Medical Research Council
The Danish Medical Society in Copenhagen
AP Moeller Foundation
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Principal Investigator: Line Rode, MD Ultrasound Clinic 4002, Rigshospitalet
Study Director: Ann Tabor, professor Ultrasound Clinic 4002, Rigshospitalet
Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Professor Ann Tabor, Rigshospitalet Identifier: NCT00329914    
Other Study ID Numbers: predict2006
First Posted: May 25, 2006    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: February 2009
Keywords provided by Rigshospitalet, Denmark:
Preterm delivery
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs