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改良式法国门诊剖宫产术与标准剖宫产技术的比较——一项随机双盲对照试验

Comparison between the modified French AmbUlatory Cesarean Section and standard cesarean technique-a randomized double-blind controlled trial.

作者信息

Sagi Shlomi, Bleicher Inna, Bakhous Rabia, Pelts Amir, Talhamy Samira, Caspin Orna, Sammour Rami, Sagi-Dain Lena

机构信息

Department of Obstetrics and Gynecology, Bnai Zion Medical Center, Haifa, Israel (MD Sagi, MD Bleicher, MD Bakhous, MD Pelts, MD Talhamy, Caspin, and MD Sammour); The Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel (MD Sagi and MD Sagi-Dain).

Department of Obstetrics and Gynecology, Bnai Zion Medical Center, Haifa, Israel (MD Sagi, MD Bleicher, MD Bakhous, MD Pelts, MD Talhamy, Caspin, and MD Sammour).

出版信息

Am J Obstet Gynecol MFM. 2023 Jul;5(7):100910. doi: 10.1016/j.ajogmf.2023.100910. Epub 2023 Feb 23.

DOI:10.1016/j.ajogmf.2023.100910
PMID:36828283
Abstract

BACKGROUND

The French AmbUlatory Cesarean Section is a cesarean delivery technique, which includes a vertical fascial incision to the left of the linea alba and an extraperitoneal approach to the uterus. The presumed benefits of this technique are decreased postoperative pain and accelerated recovery. However, evidence supporting these impressions is scarce.

OBJECTIVE

This study aimed to compare maternal recovery after French AmbUlatory Cesarean Section vs standard cesarean delivery technique.

STUDY DESIGN

In this double-blind randomized controlled trial, women undergoing elective cesarean delivery at term were allocated into French AmbUlatory Cesarean Section vs standard cesarean delivery technique. A modified French AmbUlatory Cesarean Section technique was used, adhering to all French AmbUlatory Cesarean Section operative steps except for the extraperitoneal approach. In both groups, the use of intravenous hydration, intrathecal morphine, and bladder catheter was avoided, and all women were encouraged to stand and walk 3 to 4 hours after the operation. The primary adverse composite outcome included either of the following: a visual analog scale score of >6 at 3 to 4 hours after the operation, an inability to stand up and walk to the restroom 3 to 4 hours after the operation, and a 15-Item Quality of Recovery (QoR) questionnaire score of <90 at 24 hours after the operation. The women were followed up for 6 weeks.

RESULTS

Overall, 116 women were included in the trial (58 in each group). The adverse composite outcome did not differ between the 2 groups (38.9% for the French AmbUlatory Cesarean Section group vs 53.8% for the regular cesarean delivery group; P=.172). In both groups, more than 90% of the women were able to get up and walk 3 to 4 hours after the operation. Compared with the standard cesarean delivery group, the French AmbUlatory Cesarean Section group had a longer duration of the operation (43.7±11.2 vs 54.4±11.3 minutes; P<.001), a higher rate of intraoperative complications (0.0% vs 13.8%; P=.006), and a higher rate of umbilical cord pH level of <7.2 (3.4% vs 17.2%; P=.029) were noted. Evaluation via phone call 1 week after the operation showed better quality of recovery scores in the French AmbUlatory Cesarean Section group than in the standard cesarean delivery group (27.1±8.4 vs 24.6±8.0; P=.043). Other secondary outcomes did not differ between the 2 groups.

CONCLUSION

As excellent maternal recovery was noted in both groups, we believe that the main factor affecting this recovery is the perioperative management (including avoidance of the use of intraoperative intravenous hydration, intrathecal morphine, and bladder catheter, with early postoperative mobilization). The maternal and neonatal safety outcomes of the French AmbUlatory Cesarean Section technique remain to be proven by larger-scale high-quality randomized controlled trials.

摘要

背景

法国门诊剖宫产术是一种剖宫产分娩技术,包括在白线左侧做垂直筋膜切口以及经腹膜外途径进入子宫。该技术的假定益处是术后疼痛减轻和恢复加快。然而,支持这些观点的证据很少。

目的

本研究旨在比较法国门诊剖宫产术与标准剖宫产分娩技术后的产妇恢复情况。

研究设计

在这项双盲随机对照试验中,足月行择期剖宫产的妇女被分为法国门诊剖宫产术组和标准剖宫产分娩技术组。采用了改良的法国门诊剖宫产术技术,除经腹膜外途径外,遵循所有法国门诊剖宫产术的手术步骤。两组均避免使用静脉补液、鞘内注射吗啡和膀胱导管,并鼓励所有妇女在术后3至4小时站立和行走。主要不良复合结局包括以下任何一项:术后3至4小时视觉模拟量表评分>6、术后3至4小时无法站起来走到卫生间以及术后24小时15项恢复质量(QoR)问卷评分<90。对这些妇女进行了6周的随访。

结果

总体而言,11上一篇:16名妇女纳入试验(每组58名)。两组的不良复合结局无差异(法国门诊剖宫产术组为38.9%,标准剖宫产分娩组为53.8%;P = 0.172)。两组中,超过90%的妇女在术后3至4小时能够起床行走。与标准剖宫产分娩组相比,法国门诊剖宫产术组的手术时间更长(43.7±11.2 vs 54.4±11.3分钟;P<0.001),术中并发症发生率更高(0.0% vs 13.8%;P = 0.006),脐动脉血pH值<7.2的发生率更高(3.4% vs 17.2%;P = 0.029)。术后1周通过电话评估显示,法国门诊剖宫产术组的恢复质量评分优于标准剖宫产分娩组(27.1±8.4 vs 24.6±8.0;P = 0.043)。两组的其他次要结局无差异。

结论

由于两组均观察到产妇恢复良好,我们认为影响这种恢复的主要因素是围手术期管理(包括避免术中使用静脉补液、鞘内注射吗啡和膀胱导管,以及术后早期活动)。法国门诊剖宫产术技术的产妇和新生儿安全结局仍有待大规模高质量随机对照试验证实。

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