Early medical abortion with self-administered low-dose mifepristone in combination with misoprostol.

AIM: The aim of the present study was to investigate the safety and efficacy of low-dose mifepristone combined with self-administered misoprostol for termination of early pregnancy. METHODS: A total of 533 women seeking medical abortion in early pregnancy (≤49 days since the last menstrual period) were divided randomly into hospital- (H-Mis, 250) and self- (S-Mis, 283) administered misoprostol groups. Women in two groups took 100 mg of oral mifepristone in hospital followed by 200 µg of sublingual misoprostol 24 h later in hospital or home. The primary outcome parameter was complete abortion without surgical intervention. Secondary outcomes were uterine bleeding, return of regular menses, side effects and patient acceptability. RESULTS: High rates of complete abortion were observed for both the H-Mis group (243/250; 94.8%) and the S-Mis group (266/283; 94.0%). No significant differences in outcomes (complete abortion/failure rates) or side effects were observed between the two groups. General satisfaction rates were similar for the two groups (H-Mis, 231/250, 92.4%; S-Mis, 263/283, 92.9%; P > 0.05). Higher convenience of administration (H-Mis, 211/250, 84.4%; S-Mis, 270/283, 95.4%; P < 0.05) and privacy protection (H-Mis, 214/250, 85.6%; S-Mis, 267/283, 94.3%; P < 0.05) satisfaction rates were obtained for the S-Mis group than for the H-Mis group. CONCLUSION: Self-administered sublingual misoprostol is as safe and effective as hospital-administered misoprostol following low-dose mifepristone to terminate early pregnancy (≤49 days of amenorrhoea) with fewer side effects.

Efficacy, Safety, and Acceptability of Low-Dose Mifepristone and Self-Administered Misoprostol for Ultra-Early Medical Abortion: A Randomized Controlled Trial.

The aim of this study was to investigate the efficacy, safety, and acceptability of low-dose mifepristone combined with self-administered misoprostol for ultra-early medical abortion. A total of 744 women with ultra-early pregnancy (amenorrhea ≤35 days) who fulfilled the inclusion criteria were enrolled in the study. Equal numbers of participants were allocated randomly to the hospital administration and self-administration groups. All participants took 75 mg mifepristone at the initial visit and 400 µg oral misoprostol 24 hours later in the hospital or by self-administration. The primary end point was complete abortion. Secondary end points were rates of unscheduled reattendance, time required for and cost of hospital observation and follow-up, vaginal bleeding, adverse effects, menstrual disturbance in the posttreatment period, and satisfaction rating. No differences in the rates of complete abortion, unscheduled reattendance, vaginal bleeding, adverse effects, or return of posttreatment menstruation were observed. The time required for (and costs of) hospital observation and follow-up per participant was 557.82 minutes (and US$40.12) in the hospital administration group and 18.46 minutes (and US$1.96) in the self-administration group (both P < .001). Satisfaction rates were similar in both groups, but the rates of "very satisfied" responses (87.60% vs 25.41%) and follow-up compliance (loss to follow-up, 0.45% vs 7.70%) were higher in the self-administration group (both P < .001). Low-dose mifepristone combined with self-administered misoprostol for ultra-early pregnancy termination was as effective and safe as hospital administration, with greater acceptability and lower cost to the women.