L Cheng1, C Tong, Z Xiao. 1. Shanghai Institute of Family Planning Technical Instruction, International Peace Maternity & Child Health Hospital, Welfare Institute, Shanghai 200030.
Abstract
OBJECTIVE: To investigate the efficacy of three different low doses of mifepristone for emergency contraception, the side effects and the influence to the next menstruation. METHODS: A randomized multicentre trial was conducted in Shanghai. 639 women with regular cycles and history of unprotected intercourse within 120 h of attendance were recruited, and they were randomly assigned to three groups. Group I (n = 214) mifepristone 50 mg was given, group II (n = 214) 25 mg and group III (n = 211) 10 mg. RESULTS: There were eight pregnancies totally, 2 cases in group I, 1 in group II and 5 in group III. After correction for method failure there was only 1 pregnancy in each group and the contraceptive effectiveness rate were 93.4%, 93.3% and 93.8% respectively. The side effects of mifepristone were slight and tolerable and there was significant difference between the 50 mg group and the lower doses (25 mg and 10 mg) groups (P < 0.05) in women with no complaints. There were about 12%-14% women had a early onset of menses and about 25%-28% had a late one, but no significant differences were found among the 3 groups. The average days of delayed onset of next menstruation were significant longer in group I than that in group III (P < 0.05). CONCLUSION: All the 3 doses of mifepristone could be used as an effective emergency contraception.
RCT Entities:
OBJECTIVE: To investigate the efficacy of three different low doses of mifepristone for emergency contraception, the side effects and the influence to the next menstruation. METHODS: A randomized multicentre trial was conducted in Shanghai. 639 women with regular cycles and history of unprotected intercourse within 120 h of attendance were recruited, and they were randomly assigned to three groups. Group I (n = 214) mifepristone 50 mg was given, group II (n = 214) 25 mg and group III (n = 211) 10 mg. RESULTS: There were eight pregnancies totally, 2 cases in group I, 1 in group II and 5 in group III. After correction for method failure there was only 1 pregnancy in each group and the contraceptive effectiveness rate were 93.4%, 93.3% and 93.8% respectively. The side effects of mifepristone were slight and tolerable and there was significant difference between the 50 mg group and the lower doses (25 mg and 10 mg) groups (P < 0.05) in women with no complaints. There were about 12%-14% women had a early onset of menses and about 25%-28% had a late one, but no significant differences were found among the 3 groups. The average days of delayed onset of next menstruation were significant longer in group I than that in group III (P < 0.05). CONCLUSION: All the 3 doses of mifepristone could be used as an effective emergency contraception.