Norman, Jane E., Mackenzie, Fiona, Owen, Philip, Mactier, Helen, Hanretty, Kevin, Cooper, Sarah, Calder, Andrew, Mires, Gary, Danielian, Peter, Sturgiss, Stephen, MacLennan, Graeme, Tydeman, Graham, Thornton, Steve, Martin, Bill, Thornton, James G., Neilson, James P. and Norrie, John. (2009) Progesterone for the prevention of preterm birth in twin pregnancy (STOPPIT): a randomised, double-blind, placebo-controlled study and meta-analysis. Lancet, Vol.373 (No.9680). pp. 2034-2040. ISSN 0140-6736

Full text not available from this repository.

Abstract

Background Women with twin pregnancy are at high risk for spontaneous preterm delivery. Progesterone seems to be effective in reducing preterm birth in selected high-risk singleton pregnancies, albeit with no significant reduction in perinatal mortality and little evidence of neonatal benefit. We investigated the use of progesterone for prevention of preterm birth in twin pregnancy. Methods In this double-blind, placebo-controlled trial, 500 women with twin pregnancy were recruited from nine UK National Health Service clinics specialising in the management of twin pregnancy. Women were randomised, by permuted blocks of randomly mixed sizes, either to daily vaginal progesterone gel 90 mg (n=250) or to placebo gel (n=250) for 10 weeks from 24 weeks' gestation. All study personnel and participants were masked to treatment assignment for the duration of the study. The primary outcome was delivery or intrauterine death before 34 weeks' gestation. Analysis was by intention to treat. Additionally we undertook a meta-analysis of published and unpublished data to establish the efficacy of progesterone in prevention of early (<34 weeks' gestation) preterm birth or intrauterine death in women with twin pregnancy. This study is registered, number ISRCTN35782581. Findings Three participants in each group were lost to follow-up, leaving 247 analysed per group. The combined proportion of intrauterine death or delivery before 34 weeks of pregnancy was 24.7% (61/247) in the progesterone group and 19.4% (48/247) in the placebo group (odds ratio [OR] 1.36, 95% CI 0.89-2.09; p=0.16). The rate of adverse events did not differ between the two groups. The meta-analysis confirmed that progesterone does not prevent early preterm birth in women with twin pregnancy (pooled OR 1.16, 95% Cl 0.89-1.51). Interpretation Progesterone, administered vaginally, does not prevent preterm birth in women with twin pregnancy.

Item Type:	Journal Article
Subjects:	R Medicine
Divisions:	Faculty of Medicine > Warwick Medical School
Journal or Publication Title:	Lancet
Publisher:	The Lancet Publishing Group
ISSN:	0140-6736
Date:	13 June 2009
Volume:	Vol.373
Number:	No.9680
Number of Pages:	7
Page Range:	pp. 2034-2040
Identification Number:	10.1097/01.ogx.0000359277.44843.10
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Restricted or Subscription Access
Funder:	Chief Scientist Office of the Scottish Government Health Directorate
Grant number:	CZH/4/200
URI:	http://wrap.warwick.ac.uk/id/eprint/27745

Data sourced from Thomson Reuters' Web of Knowledge

Request changes to a record

Actions (login required)

View Item