A Randomized Trial of Hospital Vs Home Self Administration of Vaginal Misoprostol for Medical Abortion

Shrestha, Anju; Sedhai, L B

doi:10.3126/kumj.v12i3.13715

Cited by 8 publications

(8 citation statements)

References 18 publications

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“…29 In a prospective, comparative, non-randomized, open-label study in Nepal, Conkling et al found that self-administration of vaginal misoprostol was safe and effective for termination within 63-day LMP. 30,31 In this study, we found that home administration of low-dose misoprostol was highly acceptable. Although the satisfaction rates for the H-Mis and S-Mis groups were both high, participants indicated that they preferred self-administration owing to convenience and privacy protection.…”

Section: Self-administration Advantagesmentioning

confidence: 69%

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Early medical abortion with self‐administered low‐dose mifepristone in combination with misoprostol

Song

Tang

et al. 2018

J of Obstet and Gynaecol

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AimThe aim of the present study was to investigate the safety and efficacy of low‐dose mifepristone combined with self‐administered misoprostol for termination of early pregnancy.MethodsA total of 533 women seeking medical abortion in early pregnancy (≤49 days since the last menstrual period) were divided randomly into hospital‐ (H‐Mis, 250) and self‐ (S‐Mis, 283) administered misoprostol groups. Women in two groups took 100 mg of oral mifepristone in hospital followed by 200 μg of sublingual misoprostol 24 h later in hospital or home. The primary outcome parameter was complete abortion without surgical intervention. Secondary outcomes were uterine bleeding, return of regular menses, side effects and patient acceptability.ResultsHigh rates of complete abortion were observed for both the H‐Mis group (243/250; 94.8%) and the S‐Mis group (266/283; 94.0%). No significant differences in outcomes (complete abortion/failure rates) or side effects were observed between the two groups. General satisfaction rates were similar for the two groups (H‐Mis, 231/250, 92.4%; S‐Mis, 263/283, 92.9%; P > 0.05). Higher convenience of administration (H‐Mis, 211/250, 84.4%; S‐Mis, 270/283, 95.4%; P < 0.05) and privacy protection (H‐Mis, 214/250, 85.6%; S‐Mis, 267/283, 94.3%; P < 0.05) satisfaction rates were obtained for the S‐Mis group than for the H‐Mis group.ConclusionSelf‐administered sublingual misoprostol is as safe and effective as hospital‐administered misoprostol following low‐dose mifepristone to terminate early pregnancy (≤49 days of amenorrhoea) with fewer side effects.

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Section: Self-administration Advantagesmentioning

confidence: 69%

“…In a prospective, comparative, non‐randomized, open‐label study in Nepal, Conkling et al . found that self‐administration of vaginal misoprostol was safe and effective for termination within 63‐day LMP …”

Section: Discussionmentioning

confidence: 98%

Early medical abortion with self‐administered low‐dose mifepristone in combination with misoprostol

Song

Tang

et al. 2018

J of Obstet and Gynaecol

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“…Three studies were RCTs, and included data from 1452 women. [21][22][23] Sixteen studies were NRSs and included data from 10 124 women. 16 17 24-36 Sixteen studies were conducted in lowto-middle resource settings (Bangladesh, 25 26 India, 28 30 34 Nepal, 22 31 China, 21 23 Vietnam, 32 33 35 Tunisia, 29 35 Nigeria, 36 Albania 27 and Turkey 24 ).…”

Section: Resultsmentioning

confidence: 99%

“…35 Participants' maximum gestational age was under 9 weeks for 14 studies, 16 17 21 23 24 27- 29 31-35 and up to and including 9 weeks for the other five studies. 22 25 26 30 36 Statistically significant differences between participants in the homebased and clinic-based groups were reported on variables including primigravida, parity, age and gestational age in six studies. 16 17 28-30 32 All studies used a combination regimen that involved the administration of mifepristone and misoprostol.…”

Section: Resultsmentioning

confidence: 99%

Effectiveness, safety and acceptability of medical abortion at home versus in the clinic: a systematic review and meta-analysis in response to COVID-19

et al. 2020

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BackgroundIncreased access to home-based medical abortion may offer women a convenient, safe and effective abortion method, reduce burdens on healthcare systems and support social distancing during the COVID-19 pandemic. Home-based medical abortion is defined as any abortion where mifepristone, misoprostol or both medications are taken at home.MethodsA systematic review and meta-analysis of randomised controlled trials (RCTs) and non-randomised studies (NRSs) were conducted. We searched databases from inception to 10 July 2019 and 14 June 2020. Successful abortion was the main outcome of interest. Eligible studies were RCTs and NRSs studies with a concurrent comparison group comparing home versus clinic-based medical abortion. Risk ratios (RRs) and their 95% CIs were calculated. Estimates were calculated using a random-effects model. We used the Grading of Recommendations Assessment, Development and Evaluation approach to assess risk of bias by outcome and to evaluate the overall quality of the evidence.ResultsWe identified 6277 potentially eligible published studies. Nineteen studies (3 RCTs and 16 NRSs) were included with 11 576 women seeking abortion up to 9 weeks gestation. Neither the RCTs nor the NRS found any difference between home-based and clinic-based administration of medical abortion in having a successful abortion (RR 0.99, 95% CI 0.98 to 1.01, I2=0%; RR 0.99, 95% CI 0.97 to 1.01, I2=52%, respectively). The certainty of the evidence for the 16 NRSs was downgraded from low to very low due to high risk of bias and publication bias. The certainty of the evidence for the three RCTs was downgraded from high to moderate by one level for high risk of bias.ConclusionHome-based medical abortion is effective, safe and acceptable to women. This evidence should be used to expand women’s abortion options and ensure access to abortion for women during COVID-19 and beyond.PROSPERO registration numberCRD42020183171.

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“…5 Several studies have studied the vaginal use of misoprostol. 1,5,8 Our study evaluated the efficacy, side effects and acceptability of its sublingual use.…”

Section: Discussionmentioning

confidence: 99%

Safety, Efficacy and Acceptability of Early First Trimester Abortion using Oral Mifepristone and Sublingual Misoprostol

Shrestha

Aryal

Sharma

2018

J Nepal Health Res Council

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Background: With the legalization of medical abortion in Nepal, mifepristone-misoprostol combination via different routes has been widely used for early abortion. This study aims to evaluate the efficacy and acceptability of 200 milligrams mifepristone orally followed by 800 micrograms sublingual misoprostol in outpatient setting.Methods: It was an open-label prospective study conducted in outpatient department of a tertiary hospital over a period of 13 months. Clients upto nine weeks of pregnancy were enrolled. 200 milligrams of mifepristone orally followed by 800 micrograms of misoprostol sublingually 36 to 48 hours later were prescribed. They were followed up in 14 days sonologically or verbally through telephone. Side effects and satisfaction to the regimen were assessed through acceptability questionnaire. Mann-Whitney U test was used for analyzing categorical data.Results: A total of 47 clients were enrolled. The mean age and gestational age were 29.38 years (SD+5.914) and 6.2 weeks (SD+1.28) respectively. The commonest indications for termination were completed family and unwanted pregnancy (40.4% each). The average duration of bleeding was 5.76 days (SD +3.61). Abdominal cramping was the most common side effect (95.7%). The least acceptable parameter was the bleeding time (80.9%). For 97.9% clients, the adverse effects were acceptable. The overall success rate of the regimen was 87.2%.Conclusions: With a comparable success rate to vaginal use, home based sublingual use of misoprostol in low resource settings offers an acceptable and cost effective alternative for medical abortion upto nine weeks of pregnancy. Lesser gestational age is a useful predictor for successful abortion.

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A Randomized Trial of Hospital Vs Home Self Administration of Vaginal Misoprostol for Medical Abortion

Cited by 8 publications

References 18 publications

Early medical abortion with self‐administered low‐dose mifepristone in combination with misoprostol

Early medical abortion with self‐administered low‐dose mifepristone in combination with misoprostol

Effectiveness, safety and acceptability of medical abortion at home versus in the clinic: a systematic review and meta-analysis in response to COVID-19

Safety, Efficacy and Acceptability of Early First Trimester Abortion using Oral Mifepristone and Sublingual Misoprostol

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