Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies?
NCT ID: NCT00329914
Last Updated: 2011-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
677 participants
INTERVENTIONAL
2006-06-30
2010-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo pessaries containing peanut oil
Progesterone
Progesterone
Vaginal pessaries, 200 mg/day
Interventions
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Progesterone
Vaginal pessaries, 200 mg/day
Placebo
Placebo pessaries containing peanut oil
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent
* 18-23 weeks' gestation
* Participants must be fluent in the language spoken in the respective centres
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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The Danish Medical Research Council
OTHER
The Danish Medical Society in Copenhagen
UNKNOWN
AP Moeller Foundation
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Rigshospitalet
Principal Investigators
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Line Rode, MD
Role: PRINCIPAL_INVESTIGATOR
Ultrasound Clinic 4002, Rigshospitalet
Ann Tabor, professor
Role: STUDY_DIRECTOR
Ultrasound Clinic 4002, Rigshospitalet
Locations
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Graz University Hospital
Graz, , Austria
Innsbruck University Hospital
Innsbruck, , Austria
Klagenfurt Hospital
Klagenfurt, , Austria
Vienna University Hospital
Vienna, , Austria
Aalborg Hospital
Aalborg, , Denmark
Skejby Hospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Glostrup Hospital
Glostrup Municipality, , Denmark
Gentofte Hospital
Hellerup, , Denmark
Herlev Hospital
Herlev, , Denmark
Hilleroed Hospital
Hilleroed, , Denmark
Holbaek Hospital
Holbæk, , Denmark
Hvidovre Hospital
Hvidovre, , Denmark
Odense University Hospital
Odense, , Denmark
Roskilde Hospital
Roskilde, , Denmark
Soenderborg Hospital
Sønderborg, , Denmark
Viborg Hospital
Viborg, , Denmark
Countries
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References
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Rode L, Klein K, Nicolaides KH, Krampl-Bettelheim E, Tabor A; PREDICT Group. Prevention of preterm delivery in twin gestations (PREDICT): a multicenter, randomized, placebo-controlled trial on the effect of vaginal micronized progesterone. Ultrasound Obstet Gynecol. 2011 Sep;38(3):272-80. doi: 10.1002/uog.9093.
Klein K, Rode L, Nicolaides KH, Krampl-Bettelheim E, Tabor A; PREDICT Group. Vaginal micronized progesterone and risk of preterm delivery in high-risk twin pregnancies: secondary analysis of a placebo-controlled randomized trial and meta-analysis. Ultrasound Obstet Gynecol. 2011 Sep;38(3):281-7. doi: 10.1002/uog.9092.
Rode L, Klein K, Larsen H, Holmskov A, Andreasen KR, Uldbjerg N, Ramb J, Bodker B, Skibsted L, Sperling L, Hinterberger S, Krebs L, Zingenberg H, Weiss EC, Strobl I, Laursen L, Christensen JT, Skogstrand K, Hougaard DM, Krampl-Bettelheim E, Rosthoj S, Vogel I, Tabor A. Cytokines and the risk of preterm delivery in twin pregnancies. Obstet Gynecol. 2012 Jul;120(1):60-8. doi: 10.1097/AOG.0b013e31825bc3cd.
Related Links
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Related Info
Other Identifiers
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predict2006
Identifier Type: -
Identifier Source: org_study_id
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