医学
概念产品
米索前列醇
四分位间距
怀孕
随机对照试验
产科
临床终点
药物流产
外科
流产
遗传学
生物
作者
Yossi Tzur,Roza Berkovitz Shperling,Tamar Goitein Inbar,Shikma Bar-On,Yaron Gil,Ishai Levin,Aviad Cohen
标识
DOI:10.1016/j.ajog.2022.06.025
摘要
Background Despite the rise of medical treatments for the termination of pregnancy, to date, no prospective trial has evaluated the efficacy of misoprostol in treating retained products of conception after induced termination of pregnancy. Objective This study aimed to compare medical management with misoprostol with expectant management for retained products of conception after first-trimester medical termination of pregnancy. Study Design This was an open-label randomized controlled trial conducted at a university-affiliated tertiary medical center. Consenting consecutive women who underwent a routine 3-week follow-up evaluation after medical termination of pregnancy and had a sonographic suspicion of retained products of conception, defined as sonographic evidence of intrauterine remnant (>12 mm) with a positive Doppler flow, were recruited. The participants were randomized into a medical treatment group (800 μg of sublingually administered misoprostol) or expectant management. They all underwent repeat ultrasound scans every 2 weeks until a maximum of 6 weeks, and those suspected of persistent retained products of conception were referred to operative hysteroscopy. The primary endpoint was successful treatment defined as no need for surgical intervention because of persistent retained products of conception within 8 weeks from pregnancy termination. Results There was no marked difference in demographic characteristics between the study groups. The median sonographically demonstrated retained product length was 20 mm (interquartile range, 17–25) in the medically managed group compared with 20 mm (interquartile range, 17–26) in the expectantly managed group (P=.733). Treatment succeeded in 42 of 68 women (61.8%) in the medically managed group compared with 36 of 63 women (57.1%) in the expectantly managed group (relative risk, 1.12; 95% confidence interval, 0.74–1.70; P=.590). There was no difference in adverse outcomes between the 2 groups. Conclusion There was no clinically meaningful advantage for medical treatment with misoprostol compared with expectant management after first-trimester medical termination of pregnancy in women with suspected retained products of conception. Surgical intervention can be avoided in up to 60% of women who are managed expectantly for 8 weeks of follow-up. Despite the rise of medical treatments for the termination of pregnancy, to date, no prospective trial has evaluated the efficacy of misoprostol in treating retained products of conception after induced termination of pregnancy. This study aimed to compare medical management with misoprostol with expectant management for retained products of conception after first-trimester medical termination of pregnancy. This was an open-label randomized controlled trial conducted at a university-affiliated tertiary medical center. Consenting consecutive women who underwent a routine 3-week follow-up evaluation after medical termination of pregnancy and had a sonographic suspicion of retained products of conception, defined as sonographic evidence of intrauterine remnant (>12 mm) with a positive Doppler flow, were recruited. The participants were randomized into a medical treatment group (800 μg of sublingually administered misoprostol) or expectant management. They all underwent repeat ultrasound scans every 2 weeks until a maximum of 6 weeks, and those suspected of persistent retained products of conception were referred to operative hysteroscopy. The primary endpoint was successful treatment defined as no need for surgical intervention because of persistent retained products of conception within 8 weeks from pregnancy termination. There was no marked difference in demographic characteristics between the study groups. The median sonographically demonstrated retained product length was 20 mm (interquartile range, 17–25) in the medically managed group compared with 20 mm (interquartile range, 17–26) in the expectantly managed group (P=.733). Treatment succeeded in 42 of 68 women (61.8%) in the medically managed group compared with 36 of 63 women (57.1%) in the expectantly managed group (relative risk, 1.12; 95% confidence interval, 0.74–1.70; P=.590). There was no difference in adverse outcomes between the 2 groups. There was no clinically meaningful advantage for medical treatment with misoprostol compared with expectant management after first-trimester medical termination of pregnancy in women with suspected retained products of conception. Surgical intervention can be avoided in up to 60% of women who are managed expectantly for 8 weeks of follow-up.
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