Termination of early pregnancy by two regimens of mifepristone with misoprostol and mifepristone with PG05--a multicentre randomized clinical trial in China.
A multicentre randomized open clinical trial was conducted to compare the efficacy and side effects of two regimens of mifepristone with misoprostol, and mifepristone with PG05 for termination of early pregnancy (amenorrhoea < = 49 days). Six-hundred women in early pregnancy, who requested medical abortion were randomly allocated into 3 groups. In group 1 (n = 301), an initial dose of mifepristone 50 mg was given, followed by 25 mg every 12 hours up to a total dose of 150 mg mifepristone, plus a single oral dose of misoprostol 600 micrograms in the morning of the third day. In group 2 (n = 150), the same regimen of mifepristone was given, but dl-15-methyl PGF2 alpha (PG05) 1 mg vaginal suppository was inserted on the third day. In group 3 (n = 149), a single dose of mifepristone 200 mg was given and misoprostol 600 micrograms was used as in group 1. The complete abortion rate were 94.4%, 97.3%, and 94.6% for group 1, 2 and 3, respectively. 3.0, 2.0 and 2.7% of women had incomplete abortion, and 1.7, 0.7 and 2.0% of women in the 3 groups were treatment failures; in the remaining 1% in group 1 and 0.7% in group 3, treatment outcome could not be determined. There were no significant differences among the 3 groups. Lower abdominal pain was the main complaint which was reported by 82% of the subjects after PGs administration. The incidence of diarrhoea in PG05 group (38.7%) was significantly higher than that in the other two groups (21.6 and 20.1%) (P < 0.001), and so was vomiting. It was concluded that misoprostol, as an orally effective prostaglandin, in combination with mifepristone for induced abortion of early pregnancy was as effective as PG05 vaginal suppository. Besides, it has advantages of convenience of use, less side effects, easy storage and transfer, and low cost.
Sang
G W
GW
Zhejiang Academy of Medical Sciences, Hangzhou.
Weng
L J
LJ
Shao
Q X
QX
Du
M K
MK
Wu
X Z
XZ
Lu
Y L
YL
Cheng
L N
LN
D015746:Abdominal Pain / Q000139:chemically induced / Q000453:epidemiology; D000028:Abortion, Induced / Q000379:methods*; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D002681:China / Q000453:epidemiology; D003967:Diarrhea / Q000139:chemically induced / Q000453:epidemiology; D015237:Dinoprost / Q000008:administration & dosage / Q000009:adverse effects / Q000592:standards*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D015735:Mifepristone / Q000008:administration & dosage / Q000009:adverse effects / Q000592:standards*; D016595:Misoprostol / Q000008:administration & dosage / Q000009:adverse effects / Q000592:standards*; D010570:Pessaries; D011247:Pregnancy; D011261:Pregnancy Trimester, First / Q000187:drug effects; D014592:Uterine Hemorrhage / Q000139:chemically induced / Q000453:epidemiology
D016595:Misoprostol; D015735:Mifepristone; D015237:Dinoprost