Mifepristone followed by misoprostol compared with placebo followed by misoprostol as medical treatment for early pregnancy loss (the Triple M trial): A double-blind placebo-controlled randomised trial.

Autor:	Hamel C; Department of Obstetrics and Gynaecology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands.; Department of Obstetrics and Gynaecology, Radboud university medical centre, Nijmegen, the Netherlands., Coppus S; Department of Obstetrics and Gynaecology, Maxima Medical Centre, Veldhoven, the Netherlands., van den Berg J; Department of Obstetrics and Gynaecology, Gelderse Vallei Hospital, Ede, the Netherlands., Hink E; Department of Obstetrics and Gynaecology, Radboud university medical centre, Nijmegen, the Netherlands., van Seeters J; Department of Obstetrics and Gynaecology, Amphia Hospital, Breda, the Netherlands., van Kesteren P; Department of Obstetrics and Gynaecology, OLVG, the Netherlands., Merién A; Department of Obstetrics and Gynaecology, Rijnstate, Arnhem, the Netherlands., Torrenga B; Department of Obstetrics and Gynaecology, Ikazia Hospital, the Netherlands., van de Laar R; Department of Obstetrics and Gynaecology, Vie Curi Medical Centre, the Netherlands., Terwisscha van Scheltinga J; Department of Obstetrics and Gynaecology, Maasstad Hospital, Rotterdam, the Netherlands., Gaugler-Senden I; Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands., Graziosi P; Department of Obstetrics and Gynaecology, St. Antonius Hospital, Nieuwegein, the Netherlands., van Rumste M; Department of Obstetrics and Gynaecology, Catharina Hospital, Eindhoven, the Netherlands., Nelissen E; Department of Obstetrics and Gynaecology, Laurentius Hospital, Roermond, the Netherlands., Vandenbussche F; Department of Obstetrics and Gynaecology, Radboud university medical centre, Nijmegen, the Netherlands.; Department of Obstetrics and Gynaecology, Helios Klinikum Duisburg, Duisburg, Germany., Snijders M; Department of Obstetrics and Gynaecology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands.
Jazyk:	angličtina
Zdroj:	EClinicalMedicine [EClinicalMedicine] 2021 Jan 06; Vol. 32, pp. 100716. Date of Electronic Publication: 2021 Jan 06 (Print Publication: 2021).
DOI:	10.1016/j.eclinm.2020.100716
Abstrakt:	Background: Worldwide, millions of women seek treatment for early pregnancy loss (EPL) annually. Medical management with misoprostol is widely used, but only effective 60% of the time. Pre-treatment with mifepristone prior to misoprostol might improve the success rate of medical management. Methods: This was a multi-centre, double-blind, placebo-controlled randomised trial in 17 Dutch hospitals. Women with a non-viable pregnancy between 6 and 14 weeks of gestation were eligible for inclusion after at least one week of expectant management. Participants were randomised (1:1) between oral mifepristone 600 mg or an oral placebo tablet. Participants took 400 μg misoprostol orally, repeated after four hours on day two and, if necessary, day three. Primary outcome was expulsion of gestational sac and endometrial thickness <15 mm after 6-8 weeks. Analyses were done according to intention-to-treat principles. This trial is registered with ClinicalTrials.gov, NCT03212352. Findings: Between June 28th 2018 and January 8th 2020, 175 women were randomised to mifepristone and 176 to placebo, including 344 in the intention-to-treat analysis. In the mifepristone group 136 (79•1%) of 172 participants reached complete evacuation compared to 101 (58•7%) of 172 participants in the placebo group ( p <0•0001, RR 1•35, 95% CI 1•16-1•56). Incidence of serious adverse events was significantly lower in the mifepristone group with 24 (14%) patients affected versus 55 (32%) in the placebo group ( p  = 0•0005) (Table 3). Interpretation: Pre-treatment with mifepristone prior to misoprostol was more effective than misoprostol alone in managing EPL. Funding: Healthcare Insurers Innovation Foundation, Radboud University Medical Centre, Canisius Wilhelmina Hospital. Competing Interests: Dr. Hamel reports grants from Healthcare Insurers Innovation Foundation, during the conduct of the study; meant to cover costs of performing the trial, no involvement in any other aspect of the trial such as study design, data gathering/analysis, manuscript preparation. All other authors have nothing to declare. (© 2020 The Authors.)
Databáze:	MEDLINE
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