(2019) A randomized trial of progesterone in women with bleeding in early pregnancy. New England Journal of Medicine, 380 (19). pp. 1815-1824. doi:10.1056/NEJMoa1813730 ISSN 0028-4793.

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Abstract

BACKGROUND
Bleeding in early pregnancy is strongly associated with pregnancy loss. Progesterone is essential for the maintenance of pregnancy. Several small trials have suggested that progesterone therapy may improve pregnancy outcomes in women who have bleeding in early pregnancy.

METHODS
We conducted a multicenter, randomized, double-blind, placebo-controlled trial to evaluate progesterone, as compared with placebo, in women with vaginal bleeding in early pregnancy. Women were randomly assigned to receive vaginal suppositories containing either 400 mg of progesterone or matching placebo twice daily, from the time at which they presented with bleeding through 16 weeks of gestation. The primary outcome was the birth of a live-born baby after at least 34 weeks of gestation. The primary analysis was performed in all participants for whom data on the primary outcome were available. A sensitivity analysis of the primary outcome that included all the participants was performed with the use of multiple imputation to account for missing data.

RESULTS
A total of 4153 women, recruited at 48 hospitals in the United Kingdom, were randomly assigned to receive progesterone (2079 women) or placebo (2074 women). The percentage of women with available data for the primary outcome was 97% (4038 of 4153 women). The incidence of live births after at least 34 weeks of gestation was 75% (1513 of 2025 women) in the progesterone group and 72% (1459 of 2013 women) in the placebo group (relative rate, 1.03; 95% confidence interval [CI], 1.00 to 1.07; P=0.08). The sensitivity analysis, in which missing primary outcome data were imputed, resulted in a similar finding (relative rate, 1.03; 95% CI, 1.00 to 1.07; P=0.08). The incidence of adverse events did not differ significantly between the groups.

CONCLUSIONS
Among women with bleeding in early pregnancy, progesterone therapy administered during the first trimester did not result in a significantly higher incidence of live births than placebo. (Funded by the United Kingdom National Institute for Health Research Health Technology Assessment program; PRISM Current Controlled Trials number, ISRCTN14163439. opens in new tab.)

Item Type:	Journal Article
Subjects:	Q Science > QP Physiology R Medicine > RG Gynecology and obstetrics
Divisions:	Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Biomedical Sciences > Cell & Developmental Biology Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Biomedical Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Pregnancy -- Complications, Progesterone, Miscarriage -- Research
Journal or Publication Title:	New England Journal of Medicine
Publisher:	Massachussets Medical Society
ISSN:	0028-4793
Official Date:	9 May 2019
Dates:	Date Event 9 May 2019 Published 9 May 2019 Accepted
Volume:	380
Number:	19
Page Range:	pp. 1815-1824
DOI:	10.1056/NEJMoa1813730
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Restricted or Subscription Access
Copyright Holders:	Copyright © 2019, Massachusetts Medical Society
Date of first compliant deposit:	29 January 2020
Date of first compliant Open Access:	29 January 2020
RIOXX Funder/Project Grant:	Project/Grant ID RIOXX Funder Name Funder ID HTA 12/167/26 [NIHR] National Institute for Health Research http://dx.doi.org/10.13039/501100000272

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