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期待治疗与医疗管理在药物流产后宫内残留妊娠组织的随机对照研究。

Expectant vs medical management for retained products of conception after medical termination of pregnancy: a randomized controlled study.

机构信息

Department of Obstetrics and Gynecology, Lis Hospital for Women's Health, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Department of Obstetrics and Gynecology, Lis Hospital for Women's Health, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

出版信息

Am J Obstet Gynecol. 2022 Oct;227(4):599.e1-599.e9. doi: 10.1016/j.ajog.2022.06.025. Epub 2022 Jun 23.

Abstract

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.

摘要

背景

尽管有许多终止妊娠的医疗手段,但目前尚无前瞻性试验评估米索前列醇在治疗早期药物流产后妊娠组织残留方面的疗效。

目的

本研究旨在比较米索前列醇药物治疗与期待疗法治疗早期药物流产后妊娠组织残留的效果。

研究设计

这是一项在大学附属医院进行的开放标签随机对照试验。纳入在药物流产后常规进行 3 周随访且超声提示有妊娠组织残留(超声表现为宫内残留>12mm,伴多普勒血流阳性)的连续患者。将患者随机分为药物治疗组(舌下含服 800μg 米索前列醇)或期待治疗组。所有患者均每 2 周进行超声复查,最多持续 6 周,对于持续妊娠组织残留的疑似患者,建议行宫腔镜检查。主要结局是 8 周内无需因妊娠组织残留而进行手术干预的治疗成功率。

结果

两组患者的人口统计学特征无显著差异。药物治疗组的超声提示残留组织长度中位数为 20mm(四分位距 17-25),期待治疗组为 20mm(四分位距 17-26)(P=.733)。药物治疗组 68 例患者中有 42 例(61.8%)治疗成功,期待治疗组 63 例患者中有 36 例(57.1%)治疗成功(相对风险 1.12;95%置信区间 0.74-1.70;P=.590)。两组不良结局发生率无差异。

结论

对于超声提示妊娠组织残留的早期药物流产后患者,与期待治疗相比,米索前列醇药物治疗无明显临床优势。对于期待治疗 8 周的患者,可避免 60%的患者进行手术干预。

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