Document Detail


Progesterone for the prevention of preterm birth in women with multiple pregnancies: the AMPHIA trial.
MedLine Citation:
PMID:  17578562     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: 15% of multiple pregnancies ends in a preterm delivery, which can lead to mortality and severe long term neonatal morbidity. At present, no generally accepted strategy for the prevention of preterm birth in multiple pregnancies exists. Prophylactic administration of 17-alpha hydroxyprogesterone caproate (17OHPC) has proven to be effective in the prevention of preterm birth in women with singleton pregnancies with a previous preterm delivery. At present, there are no data on the effectiveness of progesterone in the prevention of preterm birth in multiple pregnancies.
METHODS/DESIGN: We aim to investigate the hypothesis that 17OHPC will reduce the incidence of the composite neonatal morbidity of neonates by reducing the early preterm birth rate in multiple pregnancies. Women with a multiple pregnancy at a gestational age between 15 and 20 weeks of gestation will be entered in a placebo-controlled, double blinded randomised study comparing weekly 250 mg 17OHPC intramuscular injections from 16-20 weeks up to 36 weeks of gestation versus placebo. At study entry, cervical length will be measured. The primary outcome is composite bad neonatal condition (perinatal death or severe morbidity). Secondary outcome measures are time to delivery, preterm birth rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal admission days for preterm labour and costs. We need to include 660 women to indicate a reduction in bad neonatal outcome from 15% to 8%. Analysis will be by intention to treat. We will also analyse whether the treatment effect is dependent on cervical length.
DISCUSSION: This trial will provide evidence as to whether or not 17OHPC-treatment is an effective means of preventing bad neonatal outcome due to preterm birth in multiple pregnancies.
TRIAL REGISTRATION: Current Controlled Trials ISRCTN40512715.
Authors:
Arianne C Lim; Kitty W M Bloemenkamp; Kees Boer; Johannes J Duvekot; Jan Jaap H M Erwich; Tom H M Hasaart; Pieter Hummel; Ben W J Mol; Jos P M Offermans; Charlotte M van Oirschot; Job G Santema; Hubertina C J Scheepers; Willem A Schöls; Frank P H A Vandenbussche; Maurice G A J Wouters; Hein W Bruinse;
Publication Detail:
Type:  Controlled Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2007-06-19
Journal Detail:
Title:  BMC pregnancy and childbirth     Volume:  7     ISSN:  1471-2393     ISO Abbreviation:  BMC Pregnancy Childbirth     Publication Date:  2007  
Date Detail:
Created Date:  2007-07-12     Completed Date:  2007-07-25     Revised Date:  2013-06-06    
Medline Journal Info:
Nlm Unique ID:  100967799     Medline TA:  BMC Pregnancy Childbirth     Country:  England    
Other Details:
Languages:  eng     Pagination:  7     Citation Subset:  IM    
Affiliation:
Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, The Netherlands. A.C.Lim@amc.nl
Data Bank Information
Bank Name/Acc. No.:
ISRCTN/ISRCTN40512715
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MeSH Terms
Descriptor/Qualifier:
Adult
Dose-Response Relationship, Drug
Double-Blind Method
Female
Humans
Hydroxyprogesterones / administration & dosage*
Infant, Newborn
Obstetric Labor, Premature / prevention & control*
Pregnancy
Pregnancy Outcome*
Pregnancy, High-Risk
Pregnancy, Multiple*
Progestins / administration & dosage*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Hydroxyprogesterones; 0/Progestins; 630-56-8/17-alpha-hydroxy-progesterone caproate
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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