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CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
Medical abortion in women of less than or equal to 56 days amenorrhoea: a comparison between gemeprost (a PGE1 analogue) alone and mifepristone and gemeprost.
OBJECTIVE: To determine the efficacy of a new dose regimen of vaginal gemeprost (1 mg every 6 h up to three doses) in induction of abortion in women less than or equal to 56 days gestation, and to compare this regimen with mifepristone (200-600 mg) followed 48 h later by a single dose of gemeprost (1 mg).
DESIGN: Two separate protocols, with 50% of the subjects randomized to one or other protocol.
SETTING: The Royal Infirmary of Edinburgh, Scotland, UK.
SUBJECTS: 301 referred by their general practitioner or local family planning clinic, requesting termination of pregnancy at less than or equal to 56 days amenorrhoea.
INTERVENTIONS: Ongoing pregnancies and incomplete abortions were terminated surgically.
MAIN OUTCOME MEASURES: Number of complete abortions, analgesic requirements and bleeding pattern following treatment.
RESULTS: Complete abortion occurred in 87% of women treated with gemeprost alone and 98% of women treated with mifepristone and gemeprost (P = 0.0004). Analgesic requirements were greater in the group treated with gemeprost alone, compared with the group treated with mifepristone and gemeprost (P = 0.0001).
CONCLUSION: The new dose regimen of gemeprost can be used for early induced abortion, but the use of mifepristone and gemeprost has several advantages over the use of gemeprost alone.
DESIGN: Two separate protocols, with 50% of the subjects randomized to one or other protocol.
SETTING: The Royal Infirmary of Edinburgh, Scotland, UK.
SUBJECTS: 301 referred by their general practitioner or local family planning clinic, requesting termination of pregnancy at less than or equal to 56 days amenorrhoea.
INTERVENTIONS: Ongoing pregnancies and incomplete abortions were terminated surgically.
MAIN OUTCOME MEASURES: Number of complete abortions, analgesic requirements and bleeding pattern following treatment.
RESULTS: Complete abortion occurred in 87% of women treated with gemeprost alone and 98% of women treated with mifepristone and gemeprost (P = 0.0004). Analgesic requirements were greater in the group treated with gemeprost alone, compared with the group treated with mifepristone and gemeprost (P = 0.0001).
CONCLUSION: The new dose regimen of gemeprost can be used for early induced abortion, but the use of mifepristone and gemeprost has several advantages over the use of gemeprost alone.
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