头位后枕骨位手动旋转后分娩方式的随机对照试验。

Delivery Mode After Manual Rotation of Occiput Posterior Fetal Positions: A Randomized Controlled Trial.

机构信息

Department of Obstetrics, the Department of Biostatistics and Methodology, the Department of Neonatal Medicine, the Department of Reproductive Medicine, Angers University Hospital, and the MITOVASC Institute, CNRS 6015, INSERM U1083, Angers University, Angers, and CESP-INSERM, U1018, Team 7, Reproductive and Sexual Health, Paris-Sud University, Kremlin-Bicêtre, France.

出版信息

Obstet Gynecol. 2021 Jun 1;137(6):999-1006. doi: 10.1097/AOG.0000000000004386.

DOI:10.1097/AOG.0000000000004386

PMID:33957650

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8132900/

Abstract

OBJECTIVE

To evaluate whether manual rotation of fetuses in occiput posterior positions at full dilation increases the rate of spontaneous vaginal delivery.

METHODS

In an open, single-center, randomized controlled trial, patients with a term, singleton gestation, epidural analgesia, and ultrasonogram-confirmed occiput posterior position at the start of the second stage of labor were randomized to either manual rotation or expectant management. Our primary endpoint was the rate of spontaneous vaginal delivery. Secondary endpoints were operative vaginal delivery, cesarean delivery, and maternal and neonatal morbidity. Analyses were based on an intention-to-treat method. A sample size of 107 patients per group (n=214) was planned to detect a 20% increase in the percent of patients with a spontaneous vaginal delivery (assuming 60% without manual rotation vs 80% with manual rotation) with 90% power and alpha of 0.05.

RESULTS

Between February 2017 and January 2020, 236 patients were randomized to either manual rotation (n=117) or expectant management (n=119). The success rate of the manual rotation maneuver, defined by conversion to an anterior position as confirmed by ultrasonogram, was 68%. The rate of the primary endpoint did not differ between the groups (58.1% in manual rotation group vs 59.7% in expectant management group (risk difference -1.6; 95% CI -14.1 to 11.0). Manual rotation did not decrease the rate of operative vaginal delivery (29.9% in manual rotation group vs 33.6% in expectant management group (risk difference -3.7; 95% CI -16.6 to 8.2) nor the rate of cesarean delivery (12.0% in manual rotation group vs 6.7% in expectant management group (risk difference 5.3; 95% CI -2.2 to 12.6). Maternal and neonatal morbidity was also similar across the two groups.

CONCLUSION

Manual rotation of occiput posterior positions at the start of second stage of labor does not increase the rate of vaginal delivery without instrumental assistance.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, NCT03009435.

摘要

目的

评估在第二产程完全扩张时手动旋转枕后位胎儿能否提高自然阴道分娩率。

方法

在一项开放、单中心、随机对照试验中，对于在第二产程开始时具有足月、单胎妊娠、硬膜外镇痛和超声确认的枕后位的患者，随机分为手动旋转组或期待管理组。我们的主要终点是自然阴道分娩率。次要终点是经阴道助产分娩、剖宫产分娩以及母婴发病率。分析基于意向治疗方法。计划每组 107 例患者（n=214），以检测手动旋转组自然阴道分娩率提高 20%（假设无手动旋转组为 60%，有手动旋转组为 80%），具有 90%的功效和 0.05 的α值。

结果

2017 年 2 月至 2020 年 1 月，236 例患者随机分为手动旋转组（n=117）或期待管理组（n=119）。超声确认的前位转换的手动旋转操作成功率为 68%。两组的主要终点率无差异（手动旋转组为 58.1%，期待管理组为 59.7%（风险差异-1.6；95%CI-14.1 至 11.0）。手动旋转并未降低经阴道助产分娩率（手动旋转组为 29.9%，期待管理组为 33.6%（风险差异-3.7；95%CI-16.6 至 8.2）或剖宫产分娩率（手动旋转组为 12.0%，期待管理组为 6.7%（风险差异 5.3；95%CI-2.2 至 12.6）。两组母婴发病率也相似。