Author/Editor		Honkanen, Helena; Piaggio, Gilda; Hertzen, Helena; Bartfai, Gyorgy; Erdenetungalag, Radnaabazar; Gemzell-Danielsson, Kristina; Gopalan, Sarala; Horga, Mihai; Jerve, Fridtjof; Mittal, Suneeta
Title		WHO multinational study of three misoprostol regimens after mifepristone for early medical abortion
Type		članek
Source		BJOG
Vol. and No.		Letnik 111, št. 7
Publication year		2004
Volume		str. 715-25
Language		eng
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 < or =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. (Abstract truncated at 2000 characters)
Descriptors		PATIENT SATISFACTION ABDOMINAL PAIN ABORTIFACIENT AGENTS, STEROIDAL ABORTION, INDUCED AMENORRHEA ANALGESICS DIZZINESS DOUBLE-BLIND METHOD FATIGUE HEADACHE MIFEPRISTONE MISOPROSTOL NAUSEA PARITY PERCEPTION TREATMENT OUTCOME VOMITING