Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies?
Effectiveness of Vaginally Administered Progesterone to Prevent Preterm Delivery in Twin Pregnancies - A Multicentre Randomized Trial
1 other identifier
interventional
677
2 countries
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2006
Typical duration for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2006
CompletedFirst Posted
Study publicly available on registry
May 25, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedJuly 25, 2011
February 1, 2009
2.7 years
May 24, 2006
July 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence of delivery < 34 weeks, in the study group versus the control group
Participants will be followed until 3 weeks after delivery
Secondary Outcomes (5)
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
Study Arms (2)
Placebo
PLACEBO COMPARATORProgesterone
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Twin pregnancy
- Informed consent
- weeks' gestation
- Participants must be fluent in the language spoken in the respective centres
You may not qualify if:
- Age \< 18 years
- Known allergy to progesterone or peanuts
- Active thromboembolic disorders or a history of hormone-associated thromboembolic disorders
- Monoamniotic twins
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- The Danish Medical Research Councilcollaborator
- The Danish Medical Society in Copenhagencollaborator
- AP Moeller Foundationcollaborator
Study Sites (17)
Graz University Hospital
Graz, 8036, Austria
Innsbruck University Hospital
Innsbruck, 6020, Austria
Klagenfurt Hospital
Klagenfurt, 9020, Austria
Vienna University Hospital
Vienna, 1090, Austria
Aalborg Hospital
Aalborg, 9100, Denmark
Skejby Hospital
Aarhus, 8200, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Glostrup Hospital
Glostrup Municipality, 2600, Denmark
Gentofte Hospital
Hellerup, 2900, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Hilleroed Hospital
Hilleroed, 3400, Denmark
Holbaek Hospital
Holbæk, 4300, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Odense University Hospital
Odense, 5000, Denmark
Roskilde Hospital
Roskilde, 4000, Denmark
Soenderborg Hospital
Sønderborg, 6400, Denmark
Viborg Hospital
Viborg, 8800, Denmark
Related Publications (3)
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.
PMID: 21739497RESULTKlein 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.
PMID: 21739499RESULTRode 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.
PMID: 22914392DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Line Rode, MD
Ultrasound Clinic 4002, Rigshospitalet
- STUDY DIRECTOR
Ann Tabor, professor
Ultrasound Clinic 4002, Rigshospitalet
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 24, 2006
First Posted
May 25, 2006
Study Start
June 1, 2006
Primary Completion
February 1, 2009
Study Completion
September 1, 2010
Last Updated
July 25, 2011
Record last verified: 2009-02