Skip to main content

Research Repository

Advanced Search

A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy

Coomarasamy, Arri; Devall, Adam J.; Cheed, Versha; Harb, Hoda; Middleton, Lee J.; Gallos, Ioannis D.; Eapen, Abey K.; Roberts, Tracy; Ogwulu, Chriscasimir C.; Goranitis, Ilias; Daniels, Jane P.; Ahmed, Amna; Bender-Atik, Ruth; Bhatia, Kalsang; Bottomley, Cecilia; Brewin, Jane; Choudhary, Meenakshi; Crosfill, Fiona; Deb, Shilpa; Duncan, W. Colin; Ewer, Andrew; Hinshaw, Kim; Holland, Tom; Izzat, Feras; Johns, Jemma; Kriedt, Kathiuska; Lumsden, Mary-Ann; Manda, Padma; Norman, Jane E.; Nunes, Natalie; Overton, Caroline E.; Quenby, Siobhan; Rao, Sandhya; Ross, Jackie; Shahid, Anupama; Underwood, Martyn; Vaithilingam, Nirmala; Watkins, Linda; Wykes, Catherine; Horne, Andrew; Jurkovic, Davor

A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy Thumbnail


Authors

Arri Coomarasamy

Adam J. Devall

Versha Cheed

Hoda Harb

Lee J. Middleton

Ioannis D. Gallos

Abey K. Eapen

Tracy Roberts

Chriscasimir C. Ogwulu

Ilias Goranitis

Amna Ahmed

Ruth Bender-Atik

Kalsang Bhatia

Cecilia Bottomley

Jane Brewin

Meenakshi Choudhary

Fiona Crosfill

Shilpa Deb

W. Colin Duncan

Andrew Ewer

Kim Hinshaw

Tom Holland

Feras Izzat

Jemma Johns

Kathiuska Kriedt

Mary-Ann Lumsden

Padma Manda

Jane E. Norman

Natalie Nunes

Caroline E. Overton

Siobhan Quenby

Sandhya Rao

Jackie Ross

Anupama Shahid

Martyn Underwood

Nirmala Vaithilingam

Linda Watkins

Catherine Wykes

Andrew Horne

Davor Jurkovic



Abstract

© 2019 Massachusetts Medical Society.
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.

Citation

Coomarasamy, A., Devall, A. J., Cheed, V., Harb, H., Middleton, L. J., Gallos, I. D., …Jurkovic, D. (2019). A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy. New England Journal of Medicine, 380(19), 1815-1824. https://doi.org/10.1056/NEJMoa1813730

Journal Article Type Article
Acceptance Date Feb 27, 2019
Online Publication Date May 9, 2019
Publication Date May 9, 2019
Deposit Date May 21, 2019
Publicly Available Date Mar 28, 2024
Journal New England Journal of Medicine
Print ISSN 0028-4793
Electronic ISSN 1533-4406
Publisher Massachusetts Medical Society
Peer Reviewed Peer Reviewed
Volume 380
Issue 19
Pages 1815-1824
DOI https://doi.org/10.1056/NEJMoa1813730
Keywords General Medicine
Public URL https://nottingham-repository.worktribe.com/output/2077376
Publisher URL https://www.nejm.org/doi/10.1056/NEJMoa1813730
Additional Information From New England Journal of Medicine, Arri Coomarasamy, M.B., Ch.B., M.D., F.R.C.O.G., Adam J. Devall, B.Med.Sci., Ph.D., Versha Cheed, M.Sc., Hoda Harb, M.B., Ch.B., Ph.D., Lee J. Middleton, B.Sc., Ioannis D. Gallos, D.M.S., M.D., Helen Williams, B.Sc., Abey K. Eapen, M.D., Ph.D., Tracy Roberts, Ph.D., R.G.N., Chriscasimir C. Ogwulu, Ph.D., Ilias Goranitis, Ph.D., Jane P. Daniels, M.Med.Sci., Ph.D., Amna Ahmed, M.B., B.S., M.R.C.O.G., Ruth Bender-Atik, B.A., Kalsang Bhatia, M.B., B.S., F.R.C.O.G., Cecilia Bottomley, DM.B.B.Chir., M.R.C.O.G., M.D., Jane Brewin, B.A., Meenakshi Choudhary, M.B., B.S., M.D., M.R.C.O.G., Ph.D., Fiona Crosfill, M.B., B.S., M.R.C.O.G., Dip.Med.Ed., Shilpa Deb, M.B., B.S., M.R.C.O.G., D.G.O., Ph.D., W. Colin Duncan, M.B., Ch.B., M.D., F.R.C.O.G., Andrew Ewer, M.B., Ch.B., M.D., M.R.C.P., F.R.C.P.C.H., Kim Hinshaw, M.B., B.S., F.R.C.O.G., Tom Holland, M.B., B.S., M.R.C.O.G., M.D., Feras Izzat, M.B., Ch.B., M.R.C.O.G., Jemma Johns, M.B., B.S., M.R.C.O.G., M.D., Kathiuska Kriedt, M.B., B.S., Mary-Ann Lumsden, M.B., B.S., M.D., F.R.C.O.G., Padma Manda, M.B., B.S., D.G.O., D.F.F.P., F.R.C.O.G., Jane E. Norman, M.B., Ch.B., M.D., F.R.C.O.G., F. Med.Sci., F.R.C.P. Edin., Natalie Nunes, M.B., B.S., M.R.C.O.G., M.D. (Res.), Caroline E. Overton, M.B., B.S., M.D., M.R.C.O.G., F.H.E.A., F.R.C.O.G., Siobhan Quenby, B.Sc., M.B., B.S., M.R.C.O.G., C.C.S.T., M.D., F.R.C.O.G., Sandhya Rao, M.B., B.S., M.D., M.R.C.O.G., Jackie Ross, M.B., B.S., F.R.C.O.G., C.C.S.T., Anupama Shahid, M.B., B.S., D.F.S.R.H., M.R.C.O.G., Martyn Underwood, M.B., Ch.B., M.R.C.O.G., Nirmala Vaithilingam, M.D., Linda Watkins, M.B., Ch.B., M.R.C.O.G., D.F.F.P., Catherine Wykes, M.B., B.S., M.R.C.O.G., M.A., Andrew Horne, M.B., Ch.B., M.R.C.O.G., Ph.D., F.R.C.O.G., and Davor Jurkovic, M.B., B.S., M.D., M.R.C.O.G., A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy, 380, 1815-1824 Copyright © 2019 Massachusetts Medical Society. Reprinted with permission.

Files






You might also like



Downloadable Citations