Accès ouvert déclaré 2019 article

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

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

198Citations signalées, ce qui n’est pas une note de qualité

32Institutions déclarées

3Pays d’affiliation déclarés

Rattachement africain : gb, au, us. Niveau de preuve : code pays fourni par la source.

Le résumé fourni par la source

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.).

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Le contrôle bibliographique ouvert

DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.

Titre Crossref: A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy
Date Crossref: 09/05/2019
Éditeur: Massachusetts Medical Society
Type: journal-article

Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.

Où se fait cette recherche

Nottingham University Hospitals NHS Trust pays non établi dans la notice
Établissement de santé
Miscarriage Association pays non établi dans la notice
Organisation à but non lucratif
Tommy's pays non établi dans la notice
Organisme public
University of Birmingham pays non établi dans la notice
Université ou école supérieure
The University of Melbourne pays non établi dans la notice
Université ou école supérieure
University of Nottingham pays non établi dans la notice
Université ou école supérieure
Nottingham City Hospital pays non établi dans la notice
Établissement de santé
South Tyneside and Sunderland NHS Foundation Trust pays non établi dans la notice
Organisation à but non lucratif
East Lancashire Hospitals NHS Trust pays non établi dans la notice
Établissement de santé
Chelsea and Westminster Hospital NHS Foundation Trust pays non établi dans la notice
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Middlesex Hospital pays non établi dans la notice
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Newcastle upon Tyne Hospitals NHS Foundation Trust London pays non établi dans la notice
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Nottingham University Hospitals NHS Trust, Miscarriage Association et Tommy's, avec 9 autres affiliations.

Une affiliation ne permet pas de déduire la nationalité d’un auteur.

Les sujets associés

Ectopic Pregnancy Diagnosis and ManagementMaternal and fetal healthcareReproductive System and Pregnancy

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