International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2021
Misoprostol versus expectant management in women with incomplete first-trimester miscarriage after failed primary misoprostol treatment: A randomized clinical trial.
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СтатьяРандомизированное исследованиеОтозванная публикацияНазвание и аннотация: Перевод в очереди
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Ali Mohammed K, Emam Samar M, Abdel-Aleem Mahmoud A, Sobh Ahmed M A
Аннотация
OBJECTIVE: To compare the effectiveness and safety of repeat misoprostol versus expectant management in women with first-trimester incomplete miscarriage who have been initially treated with misoprostol.
METHODS: The study was an open-labeled randomized controlled trial including women with an incomplete first-trimester miscarriage after administration of misoprostol. The participants were randomly assigned to vaginal misoprostol or expectant management using a computer-generated table of random numbers. The primary outcome was the number of women with a complete miscarriage at 1 week.
RESULTS: Eighty-eight women (44 women in each group) were analyzed. The rate of complete miscarriage at 1 week was significantly higher in the misoprostol group than the expectant management group-29 (69.0%) versus 7 (16.7%) (P < 0.001), respectively. Women in the misoprostol group were more satisfied (7.00 ± 0.77 vs 4.57 ± 1.61, P < 0.001) but reported more pain (7.95 ± 1.85 vs 5.26 ± 1.08, P < 0.001) than women in the expectant group. The misoprostol group reported more adverse effects than the expectant management group (P < 0.001).
CONCLUSION: In women with an incomplete first-trimester miscarriage who were initially treated with misoprostol, repeat administration of misoprostol was more effective than expectant management for achieving complete miscarriage at 1 week. However, misoprostol was associated with more adverse effects.
REGISTRATION SITE AND NUMBER: Clinicaltrials.gov: NCT03148561.
METHODS: The study was an open-labeled randomized controlled trial including women with an incomplete first-trimester miscarriage after administration of misoprostol. The participants were randomly assigned to vaginal misoprostol or expectant management using a computer-generated table of random numbers. The primary outcome was the number of women with a complete miscarriage at 1 week.
RESULTS: Eighty-eight women (44 women in each group) were analyzed. The rate of complete miscarriage at 1 week was significantly higher in the misoprostol group than the expectant management group-29 (69.0%) versus 7 (16.7%) (P < 0.001), respectively. Women in the misoprostol group were more satisfied (7.00 ± 0.77 vs 4.57 ± 1.61, P < 0.001) but reported more pain (7.95 ± 1.85 vs 5.26 ± 1.08, P < 0.001) than women in the expectant group. The misoprostol group reported more adverse effects than the expectant management group (P < 0.001).
CONCLUSION: In women with an incomplete first-trimester miscarriage who were initially treated with misoprostol, repeat administration of misoprostol was more effective than expectant management for achieving complete miscarriage at 1 week. However, misoprostol was associated with more adverse effects.
REGISTRATION SITE AND NUMBER: Clinicaltrials.gov: NCT03148561.