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


METHODS
Double-blind, randomised controlled trial.


METHODS
Fifteen gynaecological clinics in 11 countries.


METHODS
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.


METHODS
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. Twenty-three 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. Nausea, 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 than at home.
Honkanen
Helena
H
Helsinki University Central Hospital, Finland.
Piaggio
Gilda
G
Hertzen
Helena
H
Bártfai
Gyorgy
G
Erdenetungalag
Radnaabazar
R
Gemzell-Danielsson
Kristina
K
Gopalan
Sarala
S
Horga
Mihai
M
Jerve
Fridtjof
F
Mittal
Suneeta
S
Thi Nhu Ngoc
Nguyen
N
Peregoudov
Alexandre
A
Prasad
R N V
RN
Pretnar-Darovec
Alenka
A
Shah
Rashmi S
RS
Song
Si
S
Tang
Oi Shan
OS
Wu
Shang Chun
SC
D015746:Abdominal Pain / Q000139:chemically induced; D000021:Abortifacient Agents, Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D000028:Abortion, Induced / Q000379:methods*; D000568:Amenorrhea / Q000209:etiology; D000700:Analgesics / Q000627:therapeutic use; D004244:Dizziness / Q000139:chemically induced; D004311:Double-Blind Method; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D015735:Mifepristone / Q000008:administration & dosage* / Q000009:adverse effects; D016595:Misoprostol / Q000008:administration & dosage* / Q000009:adverse effects; D009325:Nausea / Q000139:chemically induced; D010298:Parity; D017060:Patient Satisfaction; D010465:Perception; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
D000021:Abortifacient Agents, Steroidal; D000700:Analgesics; D016595:Misoprostol; D015735:Mifepristone