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.
RCT Entities:
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.
Entities:
Keywords:
Abortion, Induced; Analgesia; Biology; Clinical Research; Clinical Trials; Comparative Studies; Developed Countries; Diseases; Endocrine System; Europe; Family Planning; Fertility Control, Postconception; Fetus; Gestational Age; Hormone Antagonists; Hormones; Northern Europe; Pain; Physiology; Pregnancy; Pregnancy, First Trimester; Prostaglandins; Prostaglandins, Synthetic; Reproduction; Research Methodology; Ru-486; Scotland; Signs And Symptoms; Studies; Treatment; United Kingdom