Randomized, double-blind, controlled trial of mifepristone in capsule versus tablet form followed by misoprostol for early medical abortion.
OBJECTIVE
To compare the efficacy and side-effects of mifepristone 75 mg in capsule form versus 150 mg in tablet form followed by misoprostol for medical termination of early pregnancy.


METHODS
In a prospective randomized, double-blind, placebo-controlled trial, a total of 480 women who were 49 days or less pregnant were randomized by means of a random number table to receive either two tablets in the morning and one tablet 12 h later for 2 days (group A) or three capsules orally twice daily for 2 days, the first dose being double all subsequent doses (group B). After a further 48 h, 600 microg misoprostol was given orally. Successful abortion was defined as complete abortion with no need for surgical aspiration.


RESULTS
There were no significant differences between the two study groups in the rates of complete abortion (95.4% in group A versus 96.3% in group B), incomplete abortion (3.8% in group A, 3.3% in group B) and continued pregnancy (0.8% in group A, 0.4% in group B). No significant difference in the duration and amount of vaginal bleeding was observed. The incidence of side-effects, such as vomiting, nausea, headache, diarrhea and lower abdominal pain was similar in the two groups.


CONCLUSIONS
Our results indicate that 75 mg mifepristone in capsule form combined with 600 microg misoprostol is as effective and safe as 150 mg mifepristone in tablet form for the termination of pregnancy up to 49 days.
Liao
Ai H
AH
Center of Reproductive Medicine, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, PR China. aihualiao@hotmail.com
Han
Xue J
XJ
Wu
Shu Y
SY
Xiao
Dun Zh
DZh
Xiong
Chen L
CL
Wu
Xi R
XR
D000020:Abortifacient Agents, Nonsteroidal / Q000008:administration & dosage* / Q000009:adverse effects; D000021:Abortifacient Agents, Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D000028:Abortion, Induced / Q000379:methods*; D000284:Administration, Oral; D000328:Adult; D002214:Capsules; D002681:China; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005865:Gestational Age; D006801:Humans; D015735:Mifepristone / Q000008:administration & dosage* / Q000009:adverse effects; D016595:Misoprostol / Q000008:administration & dosage* / Q000009:adverse effects; D011247:Pregnancy; D011446:Prospective Studies; D013607:Tablets; D016896:Treatment Outcome
D000020:Abortifacient Agents, Nonsteroidal; D000021:Abortifacient Agents, Steroidal; D002214:Capsules; D013607:Tablets; D016595:Misoprostol; D015735:Mifepristone