Comparison of Mifepristone Followed by Misoprostol with Misoprostol Alone for Treatment of Early Pregnancy Failure: A Randomized Double-Blind Placebo-Controlled Trial

Sinha, Priya; Suneja, Amita; Guleria, Kiran; Aggarwal, Richa; Vaid, Neelam

doi:10.1007/s13224-017-0992-5

Cited by 28 publications

(31 citation statements)

References 8 publications

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“…These findings are consistent with other previously published trials. 18 , 23 , 24 A Cochrane review published in 2019 25 identified three previously published trials that evaluated the effectiveness of mifepristone and misoprostol versus misoprostol alone in the medical management of miscarriage. These trials included smaller numbers of participants (60 to 300 participants).…”

Section: Discussionmentioning

confidence: 99%

Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial

et al. 2020

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Summary Background The anti-progesterone drug mifepristone and the prostaglandin misoprostol can be used to treat missed miscarriage. However, it is unclear whether a combination of mifepristone and misoprostol is more effective than administering misoprostol alone. We investigated whether treatment with mifepristone plus misoprostol would result in a higher rate of completion of missed miscarriage compared with misoprostol alone. Methods MifeMiso was a multicentre, double-blind, placebo-controlled, randomised trial in 28 UK hospitals. Women were eligible for enrolment if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy, chose to have medical management of miscarriage, and were willing and able to give informed consent. Participants were randomly assigned (1:1) to a single dose of oral mifepristone 200 mg or an oral placebo tablet, both followed by a single dose of vaginal, oral, or sublingual misoprostol 800 μg 2 days later. Randomisation was managed via a secure web-based randomisation program, with minimisation to balance study group assignments according to maternal age (<30 years vs ≥30 years), body-mass index (<35 kg/m 2 vs ≥35 kg/m 2 ), previous parity (nulliparous women vs parous women), gestational age (<70 days vs ≥70 days), amount of bleeding (Pictorial Blood Assessment Chart score; ≤2 vs ≥3), and randomising centre. Participants, clinicians, pharmacists, trial nurses, and midwives were masked to study group assignment throughout the trial. The primary outcome was failure to spontaneously pass the gestational sac within 7 days after random assignment. Primary analyses were done according to intention-to-treat principles. The trial is registered with the ISRCTN registry, ISRCTN17405024. Findings Between Oct 3, 2017, and July 22, 2019, 2595 women were identified as being eligible for the MifeMiso trial. 711 women were randomly assigned to receive either mifepristone and misoprostol (357 women) or placebo and misoprostol (354 women). 696 (98%) of 711 women had available data for the primary outcome. 59 (17%) of 348 women in the mifepristone plus misoprostol group did not pass the gestational sac spontaneously within 7 days versus 82 (24%) of 348 women in the placebo plus misoprostol group (risk ratio [RR] 0·73, 95% CI 0·54–0·99; p=0·043). 62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53–0·95; p=0·021). We found no difference in incidence of adverse events between the study groups. Interpretation Treatment with mifepristone plus misoprostol was more effective than misoprostol alone in t...

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Section: Discussionmentioning

confidence: 99%

Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial

et al. 2020

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“…Conflict of interest was declared as not present in only seven studies (7/46, 15.2%) and was not reported on in the remaining studies. Only four studies were double blinded and these were studies comparing medical treatments to placebo (3/46, 6%) (Bagratee et al, 2004;Blohm et al, 2005;Lister et al, 2005;Sinha et al, 2018). A summary of risk of bias assessment on included trials is provided in Supplementary Table SII.…”

Section: Risk Of Biasmentioning

confidence: 99%

“…We judged blinding to be possible in seven studies (Bagratee et al, 2004;Blohm et al, 2005;Herabutya and O-Prasertsawat, 1997;Lister et al, 2005;Ngai et al, 2001;Nielsen et al, 1999;Wood and Brain, 2002). Of these, only four (Bagratee et al, 2004;Blohm et al, 2005;Lister et al, 2005;Sinha et al, 2018) were blinded, introducing a potential risk of bias. Lack on information on blinding for outcomes assessment is another limitation in the included studies.…”

Section: Strength and Limitationsmentioning

confidence: 99%

Management of first-trimester miscarriage: a systematic review and network meta-analysis

Wattar

Murugesu

Tobías

et al. 2019

Human Reproduction Update

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“…However, the adverse effects of the different treatments have to be considered. Vacuum aspiration includes a small risk of cervical tears and uterine perforation after induced abortion whereas mifepristone treatment is more efficient than misoprostol alone, but there is also a risk of excessive bleeding that might require hospital care …”

Section: Discussionmentioning

confidence: 99%

Women’s experiences of miscarriage related to diagnosis, duration, and type of treatment

Volgsten

Jansson

Darj

et al. 2018

Acta Obstet Gynecol Scand

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Comparison of Mifepristone Followed by Misoprostol with Misoprostol Alone for Treatment of Early Pregnancy Failure: A Randomized Double-Blind Placebo-Controlled Trial

Abstract: Use of mifepristone prior to misoprostol in EPF significantly improves the efficacy and reduces the side effects of misoprostol alone.

Cited by 28 publications

References 8 publications

Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial

Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial

Management of first-trimester miscarriage: a systematic review and network meta-analysis

Women’s experiences of miscarriage related to diagnosis, duration, and type of treatment

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