A randomised controlled trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion up to 13 weeks gestation

Obstetrics and Gynaecology, University of Aberdeen, Aberdeen, Scotland, United Kingdom
BJOG An International Journal of Obstetrics & Gynaecology (Impact Factor: 3.45). 08/2005; 112(8):1102-8. DOI: 10.1111/j.1471-0528.2005.00638.x
Source: PubMed


To assess women's acceptability, the efficacy and side effects of sublingual versus vaginal administration of misoprostol in combination with mifepristone for medical abortion up to 13 weeks of gestation.
Randomised controlled trial.
Aberdeen Royal Infirmary.
Women undergoing medical abortion under the terms of the 1967 Abortion Act.
Mifepristone (200 mg) was given orally followed 36-48 hours later by misoprostol administration (sublingual: 600 microg; vaginal: 800 microg). A second dose of misoprostol 400 microg was given 3 hours later (sublingually or vaginally). Women between 9 and 13 weeks of gestation received a further (third) dose of misoprostol 400 microg (sublingually or vaginally), 3 hours later if abortion had not occurred.
Women's acceptability, efficacy of the regimen and side effects experienced.
A total of 340 women were recruited (171 sublingual and 169 vaginal). A total of 70% of women in the sublingual group expressed satisfaction with the route of misoprostol administration; 18% answered 'Don't know' while 12% were dissatisfied, compared with 68%, 28% and 4%, respectively, in the vaginal group (P= 0.02). There was no significant difference in the need for surgical evacuation for women in the sublingual (3/158, 1.9%) and vaginal groups (4/156, 2.6%) (P= 0.70). Women receiving misoprostol sublingually were more likely to experience diarrhoea (P < 0.01), shivering (P < 0.01) and unpleasant mouth taste (P < 0.01).
Sublingual administration of misoprostol is an effective alternative to vaginal administration for medical abortion up to 13 weeks of gestation. The prevalence of prostaglandin-related side effects, however, was higher with this route of administration.

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    • "Recommendations for medical abortion between 9 and 12 weeks (63 and 84 days) Currently, there is limited evidence for the use of misoprostol in medical abortion between 9 and 12 weeks (63 and 84 days) of gestation. WHO recommendations are derived from only 1 randomized controlled trial and 1 observational trial; however, the principles for the regimen are similar to those for medical abortion at other gestational ages [13] [14]. Combined regimens are more effective than single-medication regimens and they should include misoprostol because it is the most effective prostaglandin for inducing medical abortion. "
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    ABSTRACT: BACKGROUND: Misoprostol, a prostaglandin E(1) analog, stimulates uterine contractility and cervical ripening. A number of randomized trials and systematic reviews have evaluated its use in obstetric and gynecologic conditions. Misoprostol is inexpensive, stable at room temperature, and available in more than 80 countries, making it particularly useful in resource-poor settings. WHO recognizes the crucial role of misoprostol in reproductive health and has incorporated recommendations for its use into 4 reproductive health guidelines focused on induction of labor, prevention and treatment of postpartum hemorrhage, and management of spontaneous and induced abortion. METHODS AND RESULTS: All guidelines were prepared in accordance with the WHO Handbook for Guideline Development. The process included: identification of priority questions and critical outcomes; retrieval of evidence; assessment and synthesis of evidence; formulation of recommendations; and planning for dissemination, implementation, impact evaluation, and updating. The present report summarizes recommendations for misoprostol use in line with each guideline. CONCLUSION: The present comprehensive reference document was designed to enable clinicians and policy makers to quickly access and compare recommendations for the use of misoprostol in various reproductive health settings.
    Full-text · Article · Feb 2013 · International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics
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    • "[4] [5] [6] [7] [8] [9] [10] "
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    ABSTRACT: Objective To test the effectiveness and acceptability of an outpatient medical abortion protocol with 200mg mifepristone and 400mcg sublingual misoprostol at 64–70 days’ LMP and compare it to the already known efficacy of the 57–63 days LMP gestational age range. Study Design We conducted a prospective, comparative open-label trial in 6 hospitals and clinics in Ukraine, Georgia, India and Tunisia. We enrolled 714 reproductive age women with pregnancies 57 to 70 days who presented requesting abortion. Medical abortions were managed with the current service delivery protocol (200mg mg oral mifepristone followed in 24-48h hours by 400mcg sublingual misoprostol). Data on safety, efficacy, and acceptability were collected. The main outcome measure was complete abortion without surgical intervention at any point. Results A total of 703 cases were analyzable for efficacy. Success rates did not differ significantly in the two groups (57–63 day group: 94·8%; 64–70 day group: 91·9% (RR: 0.79 (0.61-1·04)). Ongoing pregnancy rates also did not differ significantly (57–63 days: 1·8%; 64–70 days: 2·2% (RR: 1·10(0·65-1·87)). Conclusion A medical abortion regimen of 200mg mifepristone followed in 24–48 hours by 400mcg sublingual misoprostol is effective through 70 days gestation and may be offered within existing outpatient abortion services. Implications A regimen of 200mg mifepristone followed in 24–48 hours by 400mcg sublingual misoprostol is effective up to 70 days LMP. The findings have important implications for expanding access to outpatient medical abortion services in settings where the cost of misoprostol is of concern or a two-pill misoprostol regimen is the standard of care.
    Full-text · Article · Jan 2013 · Contraception
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    • "However, many women find vaginal administration unappealing and uncomfortable [10] [23]. Indeed, as home use of misoprostol is increasingly preferred by women, in-themouth routes offer ease of administration [10] [24]. These routes also avoid detection of pill remnants in the vagina Contraception 79 (2009) 84 – 90 where abortion is illegal or highly restricted. "
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    ABSTRACT: A 400 mcg dose of sublingual misoprostol has high efficacy and few side effects when used with 200 mg mifepristone for medical abortion through 63 days' gestation. Eligible and consenting women (n=480) were randomized to 400 mcg of misoprostol sublingually or orally, 24 h after 200 mg of mifepristone. Abortion status was assessed two weeks later. Complete abortion occurred in 98.7% of the sublingual group and 94.0% of the oral group (p value=.006, RR: 1.05, 95% CI=1.01--1.09). Over 90% of women in both arms expressed high satisfaction with the method. Side effects were similar in both groups, with only fever or chills reported by significantly more women in the sublingual arm. The sublingual route appears superior to the regimen of 400 mcg misoprostol used orally and may be a good option for mifepristone medical abortion.
    Full-text · Article · Mar 2009 · Contraception
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