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

Abstract

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...

The medical management of missed miscarriage: outcomes from a prospective, single‐centre, Australian cohort

“…42 In studies that compared 600 mcg oral misoprostol to MVA for treatment of incomplete abortion, cramping was reported by 56 to 95 percent, nausea and vomiting by 5 to 33 percent, chills by 5 and 85 percent, fever by 0.4 to 2 percent, and fever/chills by 3.8 and 15% of women. 9,10,13,19,41 Cramping generally starts within the first few hours but may begin as early as 10 minutes after misoprostol administration.…”

“…This effect has not been reported in the literature on misoprostol for treatment of incomplete abortion but has been reported in relation to the drug's use for medical abortion and as well as other indications. 42 If rash occurs, no intervention is needed but in the event of skin irritation, an antihistamine, such as Benadryl®, can be provided.…”

Randomised preference trial of medical versus surgical termination of pregnancy less than 14 weeks' gestation (TOPS)

“…Studies on early MTOP have consistently shown that procedure failure and more pain and bleeding than expected are predictors of not choosing MTOP again. 24,[87][88][89] The likelihood of each of these predictors increases with gestational age. 15,89 Of particular relevance is the increase in need for surgical evacuation following MTOP because of ongoing pregnancy or missed/incomplete abortion, which has been reported to increase from 0.9% at 9-10 weeks to 7.9% at 12-13 weeks of pregnancy.…”

“…18,20,88,102 The incidence and severity of symptoms is influenced by the dose and route of administration of misoprostol; 88 gastrointestinal symptoms and fever are more common with oral administration. 88 We found that a similar proportion of women (~ 22%) having MTOP and STOP were still bleeding 2 weeks after the procedure, although more women in the MTOP group reported heavy blood loss. Duration of bleeding has consistently been reported to be longer after MTOP than STOP and longer after abortion at 10-13 weeks compared with abortion at ≤ 9 weeks.…”

Comparison of medical abortion follow-up with serum human chorionic gonadotropin testing and in-office assessment

“…Information on LTFU rates in medical abortion literature are derived from clinical trials and are highly variable due to differences in medication administration protocol, follow-up methods and timing, patient population and laws, as well as whether the data were collected prospectively or retrospectively. Most clinical trials report LTFU rates below 5% [6,[11][12][13][14][15][16][17][18][19].…”