WHO multinational study of three misoprostol regimens after mifepristone for early medical abortion. I: Efficacy

Hertzen, Helena von; Honkanen, Helena; Piaggio, Gilda; Bártfai, György; Erdenetungalag, Radnaabazar; Gemzell‐Danielsson, Kristina; Gopalan, Sarala; Horga, Mihai; Jerve, F; Mittal, Suneeta; Ngoc, Nguyen Thi Nhu; Peregoudov, Alexandre; Prasad, Rajendra; Pretnar-Darovec, A.; Shah, Rashmi; Song, Shuai; Tang, Oi Shan; Wu, Shang Chun

doi:10.1111/j.1471-0528.2003.02430.x

Cited by 70 publications

(28 citation statements)

References 19 publications

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“…18 This is likely to be due to the fact that several of the participating centres do not provide medical abortion routinely because mifepristone has not been licensed in their country. Experienced providers report higher complete abortion rates than those with less experience.…”

Section: Discussionmentioning

confidence: 99%

Two mifepristone doses and two intervals of misoprostol administration for termination of early pregnancy: a randomised factorial controlled equivalence trial*

Hertzen¹,

Piaggio²,

Wojdyla³

et al. 2009

BJOG

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Objective To compare the efficacy of 100 mg and 200 mg of mifepristone and 24-and 48-hour intervals to administration of 800mg vaginal misoprostol for termination of early pregnancy.Design Placebo-controlled, randomized, equivalence trial, stratified by centre.Setting 13 departments of obstetrics and gynecology in nine countries.Population 2181 women with 63 days or less gestation requesting medical abortion.Methods Two-sided 95% CI for the risk differences of failure to complete abortion were calculated and compared with 5% equivalence margin between two doses of mifepristone and two intervals to misoprostol administration. Proportions of women with adverse effects were compared between the regimens using standard testes for proportions.Outcome measures Rates of complete abortion without surgical intervention and adverse effects associated with the regimens.Results Efficacy outcome was analysed for 2126 women (97.5%) excluding 55 lost to follow up. Both mifepristone doses were found to be similar in efficacy. The rate of complete abortion was 92.0% for women assigned 100 mg of mifepristone and 93.2% for women assigned 200 mg of mifepristone (difference 1.2%, 95% CI: -1.0 to 3.5). Equivalence was also evident for the two intervals of administration: the rate of complete abortion was 93.5% for 24-hour interval and 91.7% for the 48-hour interval (difference -1.8%, 95% CI: -4.0 to 0.5). Interaction between doses and interval to misoprostol administration was not significant (P = 0.92). Adverse effects related to treatments did not differ between the groups.Conclusions Both the 100 and 200 mg doses of mifepristone and the 24-and 48-hour intervals have a similar efficacy to achieve complete abortion in early pregnancy when mifepristone is followed by 800 micrograms of vaginally administered misoprostol.

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Section: Discussionmentioning

confidence: 99%

Two mifepristone doses and two intervals of misoprostol administration for termination of early pregnancy: a randomised factorial controlled equivalence trial*

Hertzen¹,

Piaggio²,

Wojdyla³

et al. 2009

BJOG

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“…However, in termination of early pregnancy, after pretreatment with mifepristone, vaginal administration of misoprostol results in better efficacy. 1,2 We wanted to study whether the frequency of side effects in vaginal use differs from that in oral use.…”

Section: Introductionmentioning

confidence: 99%

“…In a previous paper, we reported comparisons of the abortifacient efficacy, timing of expulsion and the duration of bleeding between the three regimens. 2 In this paper, we compare the detailed side effect profiles and women's perceptions of the treatments.…”

Section: Introductionmentioning

confidence: 99%

WHO multinational study of three misoprostol regimens after mifepristone for early medical abortion.

Honkanen

Piaggio

Hertzen

et al. 2004

BJOG

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Objectives To compare the side effect profiles of regimens of oral and vaginal administration of misoprostol after a single oral dose of 200 mg of mifepristone and to investigate patients' perceptions of medical abortion. Design Double-blind, randomised controlled trial.Setting Fifteen gynaecological clinics in 11 countries.Population A total of 2219 healthy pregnant women requesting medical abortion with 63 days of amenorrhoea. Two thousand women were asked about their perceptions of the method. Methods Mifepristone 200 mg orally on day one, followed by 0.8 mg misoprostol either orally or vaginally on day three. The oral group (O/O group) and one of the vaginal groups (V/O group) continued with 0.4 mg of oral misoprostol, and the vaginal-only group (V-only group) with oral placebo, twice daily for seven days. Side effects were recorded daily by women and reported at each visit. After misoprostol administration at the clinic, side effects were recorded at 1-hour interval up to 3 hours. Patients' perceptions were asked at the second follow up visit, six weeks after treatment. Main outcome measures The outcome measures were the following: pregnancy-related symptoms (nausea, vomiting, breast tenderness, fatigue, dizziness, headache), drug-related side effects (diarrhoea, fever, rash and blood pressure change), side effects related to the abortion process (lower abdominal pain) and women's perceptions of the method. Results The pregnancy-related symptoms decreased in all groups after misoprostol, and breast tenderness decreased already after mifepristone. Oral administration of misoprostol was associated with a higher frequency of nausea and vomiting than vaginal administration at 1 hour after administration. With oral misoprostol, diarrhoea was more frequent at 1, 2 and at 3 hours after administration than with vaginal administration. Misoprostol induced fever during at least 3 hours after administration in up to 6% of the women, this peak being slightly higher and taking place later with the vaginal route. Lower abdominal pain peaked at 1 and 2 hours after oral misoprostol, while it did so at 2 and 3 hours after vaginal misoprostol. In the two groups that continued misoprostol, 27% of women had diarrhoea between the misoprostol visit and the two-week follow up visit, compared with 9% in the placebo group. Among the women studied, 84% would choose medical abortion again, 9% would choose surgical abortion and 7% did not know. Twentythree percent of the women would choose to have a possible future abortion at home, 70% at a health facility and 7% did not know. Conclusions The pregnancy-related symptoms decrease significantly with time during medical abortion. BJOG: an International Journal of Obstetrics and GynaecologyNausea, vomiting and diarrhoea were more frequent after oral administration of misoprostol. Pain related to the abortion process occurs earlier after oral misoprostol. Should a need arise, a majority of women would choose medical abortion again and would prefer to have it at a health facility rather th...

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“…Misoprostol can be administered both orally or vaginally, however gastrointestinal side effects with oral administration are more [7]. In a study it has been observed that for amenorrhoea of > 57 days, vaginal misoprostol is more effective than oral administration, however no difference in efficacy was observed when amenorrhoea was < 57 days [8]. In our …”

Section: Discussionmentioning

confidence: 50%

Medical Abortion-An Alternative to Surgical Abortion

Kapur

Joneja

Biswas

2006

Medical Journal Armed Forces India

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Background: Termination of early pregnancy has traditionally been done surgically, but agents are now available which can terminate pregnancy if taken orally, vaginally or parenterally. We have used a combination of mifepristone and misoprostol for termination of early pregnancy. Material and Method: Fifty patients having amenorrhoea of upto 56 days with confirmed intrauterine pregnancy, were selected for medical termination of pregnancy. The patients were given tablet mifepristone (200mg) on day 1 and tablet misoprostol (400mcg) on day 3. On day 14, an ultrasound was done to confirm complete abortion. Result: Majority 35 (70%) patients had amenorrhoea between 40 -50 days. The duration of bleeding was less than 5 days in 12%, between 5 -10 days in 56%, 10 -13 days in 16% and greater than 14 days in 16%. In all patients with bleeding of more than 14 days ultrasonography confirmed intrauterine products & a suction evacuation was done. In this series there were no failures. Conclusion : The combination of mifepristone and misoprostol is an effective method for termination of early pregnancy up to 56 days of amenorrhoea.

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WHO multinational study of three misoprostol regimens after mifepristone for early medical abortion. I: Efficacy

Cited by 70 publications

References 19 publications

Two mifepristone doses and two intervals of misoprostol administration for termination of early pregnancy: a randomised factorial controlled equivalence trial*

Two mifepristone doses and two intervals of misoprostol administration for termination of early pregnancy: a randomised factorial controlled equivalence trial*

WHO multinational study of three misoprostol regimens after mifepristone for early medical abortion.

Medical Abortion-An Alternative to Surgical Abortion

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