横向位置。使用旋转辅助正常分娩——手法旋转后的结局（TURN-OUT 试验）：一项随机对照试验。
Transverse position. Using rotation to aid normal birth-OUTcomes following manual rotation (the TURN-OUT trial): a randomized controlled trial.
机构信息
From the Sydney Institute for Women, Children and their Families, Sydney Local Health District, Camperdown, New South Wales, Australia (Drs de Vries, Phipps, Tooher, and Hyett); Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia (Dr de Vries); Discipline of Obstetrics, Gynecology and Neonatology, The University of Sydney, New South Wales, Australia (Drs Phipps and Ludlow); Women's and Children's Hospital, Adelaide, South Australia, Australia (Drs Kuah, Matthews, Earl, and Wilkinson); Nepean Hospital, Penrith, New South Wales, Australia (Dr Pardey); RPA Women and Babies, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (Drs Ludlow, Narayan, Santiagu, Tooher, and Hyett); Ultrasound Care, Sydney, New South Wales, Australia (Dr Ludlow); Maternity and Gynaecology, John Hunter Hospital, Newcastle, New South Wales, Australia (Dr Carseldine); Faculty of Medicine and Health, The University of Sydney School of Public Health, The University of Sydney, New South Wales, Australia (Dr McGeechan).
From the Sydney Institute for Women, Children and their Families, Sydney Local Health District, Camperdown, New South Wales, Australia (Drs de Vries, Phipps, Tooher, and Hyett); Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia (Dr de Vries); Discipline of Obstetrics, Gynecology and Neonatology, The University of Sydney, New South Wales, Australia (Drs Phipps and Ludlow); Women's and Children's Hospital, Adelaide, South Australia, Australia (Drs Kuah, Matthews, Earl, and Wilkinson); Nepean Hospital, Penrith, New South Wales, Australia (Dr Pardey); RPA Women and Babies, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (Drs Ludlow, Narayan, Santiagu, Tooher, and Hyett); Ultrasound Care, Sydney, New South Wales, Australia (Dr Ludlow); Maternity and Gynaecology, John Hunter Hospital, Newcastle, New South Wales, Australia (Dr Carseldine); Faculty of Medicine and Health, The University of Sydney School of Public Health, The University of Sydney, New South Wales, Australia (Dr McGeechan).
出版信息
Am J Obstet Gynecol MFM. 2022 Jan;4(1):100488. doi: 10.1016/j.ajogmf.2021.100488. Epub 2021 Sep 17.
BACKGROUND
The fetal occiput transverse position in the second stage of labor is associated with adverse maternal and perinatal outcomes. Prophylactic manual rotation in the second stage of labor is considered a safe and easy to perform procedure that has been used to prevent operative deliveries.
OBJECTIVE
This study aimed to determine the efficacy of prophylactic manual rotation in the management of the occiput transverse position for preventing operative delivery. We hypothesized that among women who are at ≥37 weeks' gestation with a baby in the occiput transverse position early in the second stage of labor, manual rotation compared with a "sham" rotation will reduce the rate of operative delivery.
STUDY DESIGN
A double-blinded, parallel, superiority, multicenter, randomized controlled clinical trial in 3 tertiary hospitals was conducted in Australia. The primary outcome was operative (cesarean, forceps, or vacuum) delivery. Secondary outcomes were cesarean delivery, serious maternal morbidity and mortality, and serious perinatal morbidity and mortality. Outcomes were analyzed by intention to treat. Proportions were compared using χ tests adjusted for stratification variables using the Mantel-Haenszel method or Fisher exact test. Planned subgroup analyses by operator experience and technique of manual rotation (digital or whole hand rotation) were performed. The planned sample size was 416 participants (trial registration: ACTRN12613000005752).
RESULTS
Here, 160 women with a term pregnancy and a baby in the occiput transverse position in the second stage of labor, confirmed by ultrasound, were randomly assigned to receive either a prophylactic manual rotation (n=80) or a sham procedure (n=80), which was less than our original intended sample size. Operative delivery occurred in 41 of 80 women (51%) assigned to prophylactic manual rotation and 40 of 80 women (50%) assigned to a sham rotation (common risk difference, -4.2% [favors sham rotation]; 95% confidence interval, -21 to 13; P=.63). Among more experienced proceduralists, operative delivery occurred in 24 of 47 women (51%) assigned to manual rotation and 29 of 46 women (63%) assigned to a sham rotation (common risk difference, 11%; 95% confidence interval, -11 to 33; P=.33). Cesarean delivery occurred in 6 of 80 women (7.5%) in the manual rotation group and 7 of 80 women (8.7%) in the sham group. Instrumental (forceps or vacuum) delivery occurred in 35 of 80 women (44%) in the manual rotation group and 33 of 80 women (41%) in the sham group. There was no significant difference in the combined maternal and perinatal outcomes. The trial was terminated early because of limited resources.
CONCLUSION
Planned prophylactic manual rotation did not result in fewer operative deliveries. More research is needed in the use of manual rotation from the occiput transverse position for preventing operative deliveries.
背景
分娩第二产程中胎儿枕横位与产妇和围产儿不良结局相关。分娩第二产程预防性手法旋转被认为是一种安全且易于实施的操作，已被用于预防剖宫产。
目的
本研究旨在确定预防性手法旋转在管理枕横位以预防剖宫产中的效果。我们假设在≥37 孕周、第二产程早期胎头为枕横位的产妇中，与“假”旋转相比，手法旋转将降低剖宫产率。
研究设计
这是在澳大利亚 3 家三级医院进行的一项双盲、平行、优效、多中心、随机对照临床试验。主要结局为手术分娩（剖宫产、产钳或真空）。次要结局为剖宫产、严重产妇发病率和死亡率以及严重围产儿发病率和死亡率。采用意向治疗进行分析。采用 χ 检验比较比例，采用 Mantel-Haenszel 法或 Fisher 确切概率法调整分层变量进行校正。按术者经验和手法旋转（单手或双手）进行了计划的亚组分析。计划的样本量为 416 例（试验注册：ACTRN12613000005752）。
结果
这里有 160 例足月妊娠、第二产程中经超声证实为枕横位的产妇被随机分为接受预防性手法旋转（n=80）或假操作（n=80）。与最初的预期样本量相比，这一数字有所减少。80 例接受预防性手法旋转的产妇中有 41 例（51%）行手术分娩，80 例接受假操作的产妇中有 40 例（50%）行手术分娩（共同风险差异，-4.2%[有利于假操作]；95%置信区间，-21 至 13；P=.63）。在经验更丰富的术者中，47 例接受手法旋转的产妇中有 24 例（51%）行手术分娩，46 例接受假操作的产妇中有 29 例（63%）行手术分娩（共同风险差异，11%；95%置信区间，-11 至 33；P=.33）。80 例接受手法旋转的产妇中有 6 例（7.5%）行剖宫产，80 例接受假操作的产妇中有 7 例（8.7%）行剖宫产。80 例接受手法旋转的产妇中有 35 例（44%）行器械助产（产钳或真空），80 例接受假操作的产妇中有 33 例（41%）行器械助产。母婴合并结局无显著差异。由于资源有限，试验提前终止。
结论
计划的预防性手法旋转并未减少手术分娩。需要进一步研究手法旋转在预防剖宫产中的作用。
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