Outpatient versus inpatient intravaginal misoprostol for the treatment of first trimester incomplete miscarriage: a randomised controlled trial

Background There is a substantial body of research evaluating ways to prevent and manage miscarriage, but all studies do not report on the same outcomes. Objective To review systematically, outcomes reported in existing miscarriage trials. Search strategy MEDLINE, Embase, CINAHL, and Cochrane were searched from inception until January 2017. Selection criteria Randomised controlled trials (RCTs) reporting prevention or management of miscarriage. Miscarriage was defined as a pregnancy loss in the first trimester. Data collection and analysis Data about the study characteristics, primary, and secondary outcomes were extracted. Main results We retrieved 1553 titles and abstracts, from which 208 RCTs were included. For prevention of miscarriage, the most commonly reported primary outcome was live birth and the top four reported outcomes were pregnancy loss/stillbirth (n = 112), gestation of birth (n = 68), birth dimensions (n = 65), and live birth (n = 49). For these four outcomes, 58 specific measures were used for evaluation. For management of miscarriage, the most commonly reported primary outcome was efficacy of treatment. The top four reported outcomes were bleeding (n = 186), efficacy of miscarriage treatment (n = 105), infection (n = 97), and quality of life (n = 90). For these outcomes, 130 specific measures were used for evaluation. Conclusions Our review found considerable variation in the reporting of primary and secondary outcomes along with the measures used to assess them. There is a need for standardised patient‐centred clinical outcomes through the development of a core outcome set; the work from this systematic review will form the foundation of the core outcome set for miscarriage. Tweetable abstract There is disparity in the reporting of outcomes and the measures used to assess them in miscarriage trials.

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“…A total of 114 RCTs were included in the review . The PRISMA flow chart in Figure S1 shows study selection.…”

Section: Resultsmentioning

confidence: 99%

Outcomes in prevention and management of miscarriage trials: a systematic review

Smith

Dhillon-Smith

O’Toole

et al. 2018

BJOG

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“…In the usual practice, some professionals are concerned about the occurrence of infection when surgical treatment is not chosen. In 2006, the Miscarriage Treatment (MIST) Trial 31 randomized 1,200 patients diagnosed with a first-trimester miscarriage to be treated surgically, medically, or expectantly. The results showed no difference in the incidence of infection within 14 days of follow-up.…”

Section: Discussionmentioning

confidence: 99%

Efficacy, Safety, and Acceptability of Misoprostol in the Treatment of Incomplete Miscarriage: A Systematic Review and Meta-analysis

Silva,

Araujo,

Simões

et al. 2023

Rev Bras Ginecol Obstet

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Objective To assess the efficacy, safety, and acceptability of misoprostol in the treatment of incomplete miscarriage. Data sources The PubMed, Scopus, Embase, Web of Science, Cochrane Library, and Clinical Trials databases (clinicaltrials.gov) were searched for the relevant articles, and search strategies were developed using a combination of thematic Medical Subject Headings terms and text words. The last search was conducted on July 4, 2022. No language restrictions were applied. Selection of studies Randomized clinical trials with patients of gestational age up to 6/7 weeks with a diagnosis of incomplete abortion and who were managed with at least 1 of the 3 types of treatment studied were included. A total of 8,087 studies were screened. Data collection Data were synthesized using the statistical package Review Manager V.5.1 (The Cochrane Collaboration, Oxford, United Kingdom). For dichotomous outcomes, the odds ratio (OR) and 95% confidence interval (CI) were derived for each study. Heterogeneity between the trial results was evaluated using the standard test, I2 statistic. Data synthesis When comparing misoprostol with medical vacuum aspiration (MVA), the rate of complete abortion was higher in the MVA group (OR = 0.16; 95%CI = 0.07–0.36). Hemorrhage or heavy bleeding was more common in the misoprostol group (OR = 3.00; 95%CI = 1.96–4.59), but pain after treatment was more common in patients treated with MVA (OR = 0.65; 95%CI = 0.52–0.80). No statistically significant differences were observed in the general acceptability of the treatments. Conclusion Misoprostol has been determined as a safe option with good acceptance by patients.

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“…Moreover, the side effects and complications were similar between the two groups. 9 The higher success rate may be a consequence of the higher dose of misoprostol (a total of 2,400 µg) administered within a shorter interval.…”

Section: Discussionmentioning

confidence: 99%

“…4 Over the years, many studies observed the efficacy and acceptance of misoprostol as a treatment option for incomplete and delayed miscarriage, 3,5,6 and as an option in outpatient management protocols, with success rates ranging from 77.3% to 92.7%. 5,[7][8][9] The efficacy of the medical treatment with prostaglandins depends on both the dose and route of administration. Hence, the vaginal administration of misoprostol seems to be more effective than the oral administration, and has less side effects.…”

Section: Introductionmentioning

confidence: 99%

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Medical Termination of Delayed Miscarriage: Four-Year Experience with an Outpatient Protocol

Lyra

Cavaco-Gomes

Moucho

et al. 2017

Rev Bras Ginecol Obstet

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To evaluate the efficacy of an outpatient protocol with vaginal misoprostol to treat delayed miscarriage. Retrospective analysis of prospectively collected data on women medically treated for missed abortion with an outpatient protocol. The inclusion criteria were: ultrasound-based diagnosis of missed abortion with less than 10 weeks; no heavy bleeding, infection, inflammatory bowel disease or misoprostol allergy; no more than 2 previous spontaneous abortions; the preference of the patient regarding the medical management. The protocol consisted of: 1) a single dose of 800 µg of misoprostol administered intravaginally at the emergency department, after which the patients were discharged home; 2) clinical and ultrasonographic evaluation 48 hours later - if the intrauterine gestational sac was still present, the application of 800 µg of vaginal misoprostol was repeated, and the patients were discharged home; 3) clinical and ultrasonography evaluation 7 days after the initiation of the protocol - if the intrauterine gestational sac was still present, surgical management was proposed. The protocol was introduced in January 2012. Every woman received oral analgesia and written general recommendations. We also gave them a paper form to be presented and filled out at each evaluation. Complete miscarriage with misoprostol occurred in 340 women (90.2%). Surgery was performed in 37 (9.8%) patients, representing the global failure rate of the protocol. Miscarriage was completed after the first misoprostol administration in 208 (55.2%) women, with a success rate after the second administration of 78.1% (132/169). The average age of the women with complete resolution using misoprostol was superior to the average age of those who required surgery (33.99 years versus 31.74 years; = 0.031). Based on the ultrasonographic findings in the first evaluation, the women diagnosed with fetal loss achieved greater success rates compared with those diagnosed with empty sac ( = 0.049). We conclude this is an effective and safe option in the majority of delayed miscarriage cases during the first trimester, reducing surgical procedures and their consequences.

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Outpatient versus inpatient intravaginal misoprostol for the treatment of first trimester incomplete miscarriage: a randomised controlled trial

Abstract: Medical evacuation using intra-vaginal misoprostol 800 mcg eight hourly for a maximum of three doses in an outpatient setting is as effective as in inpatient setting with tolerable side effects.

Cited by 11 publications

References 30 publications

Outcomes in prevention and management of miscarriage trials: a systematic review

Outcomes in prevention and management of miscarriage trials: a systematic review

Efficacy, Safety, and Acceptability of Misoprostol in the Treatment of Incomplete Miscarriage: A Systematic Review and Meta-analysis

Medical Termination of Delayed Miscarriage: Four-Year Experience with an Outpatient Protocol

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