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评估有剖宫产史的孕妇分娩前超声测量子宫下段的有用性:一项随机试验。

Evaluation of the usefulness of ultrasound measurement of the lower uterine segment before delivery of women with a prior cesarean delivery: a randomized trial.

机构信息

Research Unit EA 7285, Department of Obstetrics and Gynecology, Hôpital Poissy-Saint Germain, Versailles Saint-Quentin University, Poissy, France.

Department of Obstetrics and Gynecology, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, Le Kremlin-Bicêtre, France.

出版信息

Am J Obstet Gynecol. 2022 Feb;226(2):253.e1-253.e9. doi: 10.1016/j.ajog.2021.08.005. Epub 2021 Aug 9.

Abstract

BACKGROUND

The main reason to avoid trial of labor after cesarean delivery is the possibility of uterine rupture. Identifying women at risk is thus an important aim, for it would enable women at low risk to proceed with a secure planned vaginal birth.

OBJECTIVE

To evaluate the impact of proposing mode of delivery based on the ultrasound measurement of the lower uterine segment thickness on a composite outcome of maternal-fetal mortality and morbidity, compared with usual management, among pregnant women with a previous cesarean delivery.

STUDY DESIGN

This multicenter, randomized, controlled, parallel-group, unmasked trial was conducted at 8 referral university hospitals with a neonatal intensive care unit and enrolled 2948 women at 36 weeks 0 days to 38 weeks 6 days of gestation with 1 previous low transverse cesarean delivery and no contraindication to trial of labor. Women in the study group had their lower uterine segment thickness measured by ultrasound. Those with measurements >3.5 mm, were encouraged to choose a planned vaginal delivery, and those with measurements ≤3.5 mm, were encouraged to choose a planned repeat cesarean delivery. This measurement was not taken in the control group; their mode of delivery was decided according to standard management. The primary outcome was a composite criterion comprising maternal mortality, uterine rupture, uterine dehiscence, hysterectomy, thromboembolic disease, transfusion, endometritis, perinatal death, or neonatal encephalopathy. Prespecified secondary outcomes were repeat cesarean deliveries, elective or after trial of labor.

RESULTS

The study group included 1472 women, and the control group included 1476 women. These groups were similar at baseline. The primary outcome occurred in 3.4% of the study group and 4.3% of the control group (relative risk, 0.78; 95% confidence interval, 0.54-1.13: risk difference, -1.0%; 95% confidence interval, -2.4 to 0.5). The uterine rupture rate in the study group was 0.4% and in the control group 0.9% (relative risk, 0.43; 95% confidence interval, 0.15-1.19). The planned cesarean delivery rate was 16.4% in the study group and 13.7% in the control group (relative risk, 1.21; 95% confidence interval, 1.00-1.47), whereas the rates of cesarean delivery during labor were 25.1% and 25.0% (relative risk, 1.01; 95% confidence interval, 0.89-1.14) in the study and control groups, respectively.

CONCLUSION

Ultrasound measurements of lower uterine segment thickness did not result in a statistically significant lower frequency of maternal and perinatal adverse outcomes than standard management. However, because this study was underpowered, further research should be encouraged.

摘要

背景

避免剖宫产术后试产的主要原因是子宫破裂的可能性。因此,识别高危产妇是一个重要的目标,因为这将使低危产妇能够安全地进行计划好的阴道分娩。

目的

评估在超声测量子宫下段厚度的基础上提出分娩方式与常规管理相比,对有既往剖宫产史的孕妇母婴死亡率和发病率的复合结局的影响。

研究设计

这是一项多中心、随机、对照、平行组、非盲临床试验,在 8 家有新生儿重症监护病房的转诊大学医院进行,纳入了 2948 名妊娠 36 周 0 天至 38 周 6 天、既往有 1 次低位横行剖宫产且无试产禁忌的孕妇。研究组的孕妇通过超声测量子宫下段厚度。那些测量值>3.5 毫米的孕妇被鼓励选择计划好的阴道分娩,那些测量值≤3.5 毫米的孕妇被鼓励选择计划好的再次剖宫产。对照组没有进行这种测量,他们的分娩方式根据标准管理决定。主要结局是包括产妇死亡、子宫破裂、子宫切开、子宫切除术、血栓栓塞疾病、输血、子宫内膜炎、围产儿死亡或新生儿脑病的复合标准。预先指定的次要结局是再次剖宫产、选择性或试产后的剖宫产。

结果

研究组包括 1472 名妇女,对照组包括 1476 名妇女。这些组在基线时相似。研究组的主要结局发生率为 3.4%,对照组为 4.3%(相对风险,0.78;95%置信区间,0.54-1.13:风险差异,-1.0%;95%置信区间,-2.4 至 0.5)。研究组的子宫破裂发生率为 0.4%,对照组为 0.9%(相对风险,0.43;95%置信区间,0.15-1.19)。研究组的计划性剖宫产率为 16.4%,对照组为 13.7%(相对风险,1.21;95%置信区间,1.00-1.47),而研究组和对照组的产时剖宫产率分别为 25.1%和 25.0%(相对风险,1.01;95%置信区间,0.89-1.14)。

结论

与标准管理相比,超声测量子宫下段厚度并没有导致母婴不良结局的频率有统计学意义的降低。然而,由于本研究的效力不足,应鼓励进一步研究。

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