Medical treatment for early fetal death (less than 24 weeks)

Lemmers, Marike; Verschoor, Marianne A.C.; Kim, Bobae Veronica; Hickey, Martha; Vázquez, Juan C; Mol, Ben Willem J.; Neilson, James P

doi:10.1002/14651858.cd002253.pub4

Cited by 52 publications

(33 citation statements)

References 201 publications

(33 reference statements)

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“…When comparing the sublingual and vaginal route we found that there may be little to no difference in effectiveness. Similar findings have been reported in previous systematic reviews, although Lemmers et al . found that the sublingual route may lead to more diarrhea and pain.…”

Section: Discussionsupporting

confidence: 90%

“…WHO recommends a combination of mifepristone and misoprostol for the management of first and second trimester induced abortion in viable pregnancies . Findings from a recently updated review on the management of fetal death below 24 weeks by Lemmers et al., suggest that the mifepristone–misoprostol regimen is equally effective to misoprostol alone. However, the data on which these findings are based do not include any cases of second trimester IUFD.…”

Section: Discussionmentioning

confidence: 99%

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A systematic review of the effectiveness, safety, and acceptability of medical management of intrauterine fetal death at 14–28 weeks of gestation

Cleeve

Fønhus

Lavelanet

2019

Intl J Gynecology & Obste

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Background Optimal dose, interval, and administration route of misoprostol with added benefit of mifepristone for management of second trimester intrauterine fetal death (IUFD) are not established. Objectives To assess effectiveness, safety, and acceptability of medical management of second trimester IUFD. Search strategy Research databases from January 2006 to October 2018. Selection criteria Randomized controlled trials with IUFD cases at 14–28 weeks of gestation. Data collection and analysis We screened and extracted data, assessed risk of bias, conducted analyses, and assessed overall certainty of the evidence. Main results Sixteen trials from 1695 citations. When misoprostol is used alone, 400 μg is more effective than 200 μg (RR 0.78; 95% CI, 0.66–0.92, moderate certainty evidence); the sublingual route is more effective than the oral route (RR 0.88; 95% CI, 0.70–1.11, low certainty evidence). There may be little to no difference between the sublingual and vaginal route (RR 0.93; 95% CI, 0.85–1.03, low certainty evidence). Certainty of evidence related to mifepristone–misoprostol regimens and safety and acceptability is very low. Conclusions Misoprostol 400 μg every 4 hours, sublingually or vaginally, may be effective. We cannot draw conclusions about safety and acceptability, or about the added benefits of mifepristone.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

A systematic review of the effectiveness, safety, and acceptability of medical management of intrauterine fetal death at 14–28 weeks of gestation

Cleeve

Fønhus

Lavelanet

2019

Intl J Gynecology & Obste

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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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“…Regarding misoprostol, many different treatment regimens are being used, as the superior regimen regarding dosage and route of administration for misoprostol remains unclear to date [23] . We chose the oral admission of 800 μg misoprostol, divided over two doses per day.…”

Section: Discussionmentioning

confidence: 99%

“…However, the evidence supporting pre-treatment with mifepristone remains insufficient, leading to conflicting recommendations in the NICE and ACOG guidelines [ 2 , 11 ]. A recent systematic review and meta-analysis concluded that the current evidence for the addition of mifepristone is ‘limited’ [22] , and the most recent Cochrane review classified the evidence level as ‘very low’ [23] . Taken together, evidence from a large, sufficiently powered, placebo-controlled, double-blinded randomised controlled trial (RCT) is needed.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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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.

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Medical treatment for early fetal death (less than 24 weeks)

Abstract: Medical treatment for early fetal death (less than 24 weeks) (Review)

Cited by 52 publications

References 201 publications

A systematic review of the effectiveness, safety, and acceptability of medical management of intrauterine fetal death at 14–28 weeks of gestation

A systematic review of the effectiveness, safety, and acceptability of medical management of intrauterine fetal death at 14–28 weeks of gestation

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

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

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