[A phase III multicentre study on medical termination of early pregnancy with two regimens of mifepristone followed by PG05].

OBJECTIVE

To compare use-effectiveness and side-effects of medical termination of early pregnancy by oral administration of separated doses of mifepristone 150 mg or single dose of mifepristone 200 mg followed by PG05 1 mg vaginally in 4500 healthy pregnant women with amenorrhea < or = 49 days in a phase I multicentre study.

METHODS

All subjects were recruited in 30 clinics after obtaining informed consents.

RESULTS

The complete, incomplete abortion and continuous pregnancy rates were 88.6%, 8.1%, 1.7% and 92.0%, 5.8%, 0.8% in single dose and separated doses groups, respectively. The efficacy of termination of early pregnancy by mifepristone 150 mg in separated doses was higher than that in single dose of mifepristone 200 mg when both in combination with PG05 1 mg (P < 0.01). One case of allergic rash was noted after administration of mifepristone. No severe side-effects were observed except bleeding problems. 65 cases received emergency vacuum aspiration and 7 of them received blood transfusion due to heavy bleeding. In addition, 2 cases of ectopic pregnancies required blood transfusion as heavy bleeding caused by exfetation disruption. There was no significant difference in to the time to start bleeding and the days of bleeding lasted between two treatment groups. However, there was a significant positive correlation (P < 0.001) between diameters of SAC and the days of bleeding lasted.

CONCLUSIONS

Logistic regression analysis suggested that subject's age, gravidity and days of amenorrhea have significant effects on abortion efficacy. 75.2% of subjects are satisfactory in self-assessment of the treatment, and 81.8% of subjects will choose medical abortion method in case they need to terminate undesired early pregnancy in the future.