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Prevention of preterm delivery in twin gestations (PREDICT): A multicentre randomised placebo-controlled trial on the effect of vaginal micronised progesterone.
MedLine Citation:
PMID:  21739497     Owner:  NLM     Status:  Publisher    
INTRODUCTION: Studies on high-risk singleton gestations have shown a preventive effect of progesterone treatment on the risk of preterm delivery. This study was conducted to investigate the preventive effect of vaginal micronised progesterone in a large population of twin gestations. MATERIAL AND METHODS: The study was performed as a double-blind, placebo-controlled randomised trial in 17 centres in Denmark and Austria. Women with twin gestations were randomised to daily treatment with progesterone pessaries or identically looking placebo pessaries starting from 20-24 weeks until 34 weeks' gestation. Primary outcome was delivery before 34 weeks. Secondary outcomes were neonatal complications and long-term infant follow-up by Ages and Stages Questionnaire (ASQ) 6 and 18 months after expected date of delivery. We updated a published meta-analysis to include our data and another recently published twin trial. RESULTS: A total of 677 women were randomised to the two treatments. Two women in the placebo group were lost to follow-up. Baseline characteristics for the groups were similar. Rate of delivery before 34 weeks was 15.3% in the progesterone group versus 18.5% in the placebo group, odds ratio 0.8 (95% confidence interval 0.5-1.2). Risks of maternal and neonatal complications were comparable for the groups. Mean ASQ-scores at 6 months were 215 for infants in the progesterone group and 218 for infants in the placebo group (p = 0.45), and 193 and 194, respectively, at 18 months of age (p = 0.89). The meta-analysis yielded an OR of 1.06 (95% CI 0.86-1.31). CONCLUSION: Progesterone treatment did not prevent preterm delivery in twin gestations. There were no harmful effects of progesterone in fetuses and infants. Copyright © 2011 ISUOG. Published by John Wiley & Sons, Ltd.
Line Rode; Katharina Klein; Kypros Nicolaides; Elisabeth Krampl-Bettelheim; Ann Tabor;
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-7-7
Journal Detail:
Title:  Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology     Volume:  -     ISSN:  1469-0705     ISO Abbreviation:  -     Publication Date:  2011 Jul 
Date Detail:
Created Date:  2011-7-8     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9108340     Medline TA:  Ultrasound Obstet Gynecol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2011 ISUOG. Published by John Wiley & Sons, Ltd.
Department of Fetal Medicine and Ultrasound 4002, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark; University of Copenhagen, Faculty of Health Sciences, Denmark.
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MeSH Terms
Ida Vogel / ; Helle Larsen / ; Anni Holmskov / ; Kirsten Riis-Andreasen / ; Niels Uldbjerg / ; Jan Ramb / ; Birgit Bødker / ; Lillian Skibsted / ; Lene Sperling / ; Stefan Hinterberger / ; Lone Krebs / ; Helle Zingenberg / ; Eva-Christine Weiss / ; Strobl Isolde / ; Lone Laursen / ; Jeanette Tranberg Christensen / ; Bo Mølholm Hansen / ; Ane Lando /

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