What is the best method for managing early miscarriage?

Chu, Justin; Hardy, Pollyanna; Beeson, Leanne; Coomarasamy, Arri

doi:10.1136/bmj.l6438

Cited by 22 publications

(22 citation statements)

References 16 publications

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“…Complications of miscarriage surgery are rare, but can include bleeding, infection, and uterine perforation requiring more extensive surgery, which carries substantial morbidity. 26 Our findings show that the combination treatment of mifepristone and misoprostol reduces the need for surgery after medical management, which could be of great importance to women who wish to undergo medical management of missed miscarriage.…”

Section: Discussionmentioning

confidence: 62%

“…Women who choose medical management of missed miscarriage often wish to have expedited treatment and resolution of their miscarriage, while avoiding the risks of surgery. 26 The risks of miscarriage surgery are dependent on the clinical context, the setting in which the procedure is done, the surgeon, and available equipment. Complications of miscarriage surgery are rare, but can include bleeding, infection, and uterine perforation requiring more extensive surgery, which carries substantial morbidity.…”

Section: Discussionmentioning

confidence: 99%

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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: 62%

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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“…7 This article reports the economic evaluation conducted alongside the MifeMiso trial. 6 The primary evaluation was a within-trial cost-effectiveness analysis (CEA) based on the outcomes of cost per successfully managed miscarriage and cost per quality-adjusted life years (QALYs) gained. Additionally, a decision-analytic model was developed to assess the cost-effectiveness of the medical management of missed miscarriage with mifepristone plus misoprostol (as explored in the trial), compared with alternative strategies beyond the trial comparisons, including surgical and expectant management and the current practice of medical management, based on available secondary sources.…”

Section: Introductionmentioning

confidence: 99%

Cost‐effectiveness of mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage: an economic evaluation based on the MifeMiso trial

Ogwulu

Williams

Chu

et al. 2021

BJOG

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Objective To assess the cost-effectiveness of mifepristone and misoprostol (MifeMiso) compared with misoprostol only for the medical management of a missed miscarriage.Design Within-trial economic evaluation and model-based analysis to set the findings in the context of the wider economic evidence for a range of comparators. Incremental costs and outcomes were calculated using nonparametric bootstrapping and reported using cost-effectiveness acceptability curves. Analyses were performed from the perspective of the UK's National Health Service (NHS).Setting Twenty-eight UK NHS early pregnancy units.Sample A cohort of 711 women aged 16-39 years with ultrasound evidence of a missed miscarriage.Methods Treatment with mifepristone and misoprostol or with matched placebo and misoprostol tablets.Main outcome measures Cost per additional successfully managed miscarriage and quality-adjusted life years (QALYs).Results For the within-trial analysis, MifeMiso intervention resulted in an absolute effect difference of 6.6% (95% CI 0.7-12.5%) per successfully managed miscarriage and a QALYs difference of 0.04% (95% CI À0.01 to 0.1%). The average cost per successfully managed miscarriage was lower in the MifeMiso arm than in the placebo and misoprostol arm, with a cost saving of £182 (95% CI £26-£338). Hence, the MifeMiso intervention dominated the use of misoprostol alone. The model-based analysis Trial Registration: ISRCTN 17405024.

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“…3 Both surgical and expectant management with spon taneous resolution have well established risks and benefits. 4 Medical management can shorten the resolu tion time and reduce the unpredictability associated with expectant management, while eliminating the inva siveness and cost of vacuum aspiration. In 2005, Zhang and colleagues 5 showed that vaginally administered misoprostol 800 mg (a prostaglandin analogue) was noninferior to surgical management.…”

Section: Medical Management Of Miscarriage With Mifepristonementioning

confidence: 99%

Medical management of miscarriage with mifepristone

Barnhart

2020

The Lancet

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What is the best method for managing early miscarriage?

Cited by 22 publications

References 16 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

Cost‐effectiveness of mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage: an economic evaluation based on the MifeMiso trial

Medical management of miscarriage with mifepristone

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