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

Autor: Versha Cheed, Caroline Overton, Mary Ann Lumsden, K. Bhatia, Tracy E Roberts, Hoda Harb, Siobhan Quenby, K. Kriedt, T. Holland, Nirmala Vaithilingam, Ioannis D. Gallos, Sanjukta Deb, P. Manda, Arri Coomarasamy, Andrew W Horne, Martin Underwood, Kim Hinshaw, C. Wykes, Natalie Nunes, A. Ahmed, Adam J. Devall, J Brewin, C. Bottomley, Helen Williams, Davor Jurkovic, Meenakshi Choudhary, Fiona Crosfill, Ilias Goranitis, Jackie Ross, Jane P Daniels, Linda Watkins, Jemma Johns, Chriscasimir C. Ogwulu, Abey Eapen, Ruth Bender-Atik, Andrew K Ewer, Feras Izzat, S. Rao, Lee J Middleton, W.C. Duncan, Jane E. Norman, A. Shahid
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Adult
medicine.medical_specialty
Early pregnancy factor
macromolecular substances
030204 cardiovascular system & hematology
Abortion
law.invention
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
Double-Blind Method
law
Abortion
Spontaneous/prevention & control
Pregnancy
medicine
Humans
030212 general & internal medicine
Treatment Failure
Uterine Hemorrhage/drug therapy
Progesterone
biology
Obstetrics
Uterine Hemorrhage
business.industry
Progesterone/administration & dosage
Obstetrics and Gynecology
Progestins/administration & dosage
General Medicine
medicine.disease
QP
Abortion
Spontaneous
Pregnancy Complications
Administration
Intravaginal
Pregnancy Trimester
First
Clinical research
Multicenter study
biology.protein
Pregnancy Complications/diagnostic imaging
Female
RG
Progestins
business
Live birth
Live Birth
Zdroj: Coomarasamy, A, Devall, A J, Cheed, V, Harb, H, Middleton, L J, Gallos, I D, Williams, H, Eapen, A K, Roberts, T, Ogwulu, C C, Goranitis, I, Daniels, J P, Ahmed, A, Bender-Atik, R, Bhatia, K, Bottomley, C, Brewin, J, Choudhary, M, Crosfill, F, Deb, S, Duncan, W C, Ewer, A, Hinshaw, K, Holland, T, Izzat, F, Johns, J, Kriedt, K, Lumsden, M-A, Manda, P, Norman, J E, Nunes, N, Overton, C E, Quenby, S, Rao, S, Ross, J, Shahid, A, Underwood, M, Vaithilingam, N, Watkins, L, Wykes, C, Horne, A & Jurkovic, D 2019, ' A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy ', New England Journal of Medicine, vol. 380, no. 19, pp. 1815-1824 . https://doi.org/10.1056/NEJMoa1813730
ISSN: 0028-4793
DOI: 10.1056/NEJMoa1813730
Popis: BACKGROUND\ud 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.\ud \ud METHODS\ud 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.\ud \ud RESULTS\ud 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.\ud \ud CONCLUSIONS\ud 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.)
Databáze: OpenAIRE
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