低风险分娩人群的医院水分娩:一项随机对照试验的结果

Emily Malloy PhD, CNM , Jessica J.F. Kram MPH , James O. Adefisoye PhD , Marie Forgie DO , Diana Kleber RN , MaryAnne Scherer CNM , Anna Anklam CNM , Natasha Hernandez MD , Lisa Hanson PhD, CNM
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引用次数: 0

摘要

水中分娩是指在一盆温水中分娩,婴儿在水下出生。在美国广泛采用水分娩的支持受到主要是回顾性研究设计、跨学科引用的利用不足以及专业组织之间的分歧的限制。在美国还没有进行过水中分娩的随机对照试验。目的:本随机对照试验的目的是比较低风险水组和陆地组研究参与者的疼痛管理、孕产妇和新生儿结局以及孕产妇满意度。研究设计:在常规产前护理期间,为妊娠25至34周的低风险孕妇提供研究参与。符合纳入标准的参与者被同意、登记,并以2:1的无盲方式随机分配到水中分娩或陆地分娩,以实现n=120的样本量(80个水中分娩:40个陆地分娩)。根据中期分析调整样本量,使样本量增加到186例(124例水中出生:62例陆地出生)。使用改良的意向治疗模型,如果两组参与者在分娩前出现产时危险因素,则将其排除在外。研究参与者接受了常规的分娩时护理,包括所有可用的疼痛缓解方案。只有那些被分配到水中分娩组的人可以选择在水中分娩。出院前,参与者完成了美国出生满意度量表修订。主要研究结果是静脉麻醉和/或硬膜外麻醉的使用。次要结局包括预先确定的产妇和新生儿综合结局和总体分娩满意度。采用改良的意向治疗方法,采用卡方检验、Fisher’s Exact检验或Wilcoxon-Mann-Whitney检验对结果进行分析。在适用的情况下计算相对风险(RR)。结果从2022年1月至2023年12月,共纳入186名参与者,其中水中出生124人,陆地出生62人。入组后,106名参与者(74名在水中出生,32名在陆地出生)仍符合研究条件。流失率为39%。与陆地分娩组相比,水中分娩组使用静脉麻醉药[RR: 0.36(95%可信区间[CI], 0.17 - 0.75), P<; 0.01]和硬膜外镇痛的可能性显著降低[RR: 0.38 (95% CI, 0.24 - 0.58), P< 0.01],平均第一产程较短[中位差-2.00小时(95% CI, -3.00至1.00),P=.43]。水中分娩组发生1例脐带撕脱。其他的产妇和新生儿结局在两组之间没有显著差异。水中分娩的参与者总体分娩满意度较高[中位数差异3.50 (95% CI, 1.00-5.00), P= 0.01]。结论越来越多的证据表明,水中分娩减少了静脉镇痛和麻醉的使用,提高了产妇的满意度。我们的研究结果为医院为低风险分娩人群提供水中分娩作为缓解疼痛的选择提供了支持。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Hospital waterbirth for low-risk birthing people: findings of a randomized controlled trial

Background

Waterbirth is the act of giving birth submerged in a tub of warm water, with the baby born underwater. Support for widespread adoption of waterbirth in the United States (US) has been limited by predominantly retrospective study designs, the underutilization of interdisciplinary citations, and disagreement between professional organizations. No randomized controlled trials of waterbirth have been conducted in the US.

Objective

The purpose of this randomized controlled trial was to compare pain management, maternal and neonatal outcomes, and maternal satisfaction between low-risk water and land group study participants.

Study Design

Low-risk pregnant adults were offered study participation between 25 to 34 weeks of gestation during routine prenatal care. Participants who met the inclusion criteria were consented, enrolled, and randomly assigned to waterbirth or land birth in a 2:1 unblinded fashion, to achieve a sample size of n=120 (80 waterbirth: 40 land birth). The sample size was adjusted for attrition and increased to n=186 (124 waterbirth: 62 land birth) based on an interim analysis. Participants in both arms were excluded if they developed intrapartum risk factors prior to delivery using a modified intention-to-treat model. Study participants received routine intrapartum care, including all available pain relief options. Only those assigned to the waterbirth group were given the option of giving birth in water. Prior to discharge, participants completed The US Birth Satisfaction Scale Revised. The primary study outcome was the use of any intravenous narcotics and/or epidural anesthesia. Secondary outcomes included predetermined composite maternal and neonatal outcomes and overall birth satisfaction. Using a modified intention-to-treat approach, outcomes were analyzed using Chi-square, Fisher’s Exact, or Wilcoxon-Mann-Whitney test as appropriate. Relative risks (RR) were computed where applicable.

Results

From January 2022 to December 2023, 186 participants were enrolled (n=124 waterbirth, n=62 land birth). Following enrollment, 106 participants (n=74 waterbirth, and n=32 land birth) remained eligible for the study. Attrition was 39%. Compared to the land birth group, waterbirth participants were significantly less likely to use intravenous narcotics [RR: 0.36 (95% confidence interval [CI], 0.17−0.75), P<.01] and epidural analgesia [RR: 0.38 (95% CI, 0.24−0.58), P<.01] and had shorter average first stage labor duration [median difference -2.00 hours (95% CI, -3.00 to 1.00), P=.43]. One cord avulsion occurred in the waterbirth group. Additional maternal and neonatal outcomes were not significantly different between groups. Waterbirth participants experienced higher overall birth satisfaction [median difference 3.50 (95% CI, 1.00-5.00), P=.01].

Conclusion

This study further contributes to the growing body of evidence that waterbirth reduces intravenous analgesia and anesthesia use and increases maternal satisfaction. The findings of our study provide support for hospitals to offer waterbirth as a pain relief option for low-risk birthing people.
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来源期刊
AJOG global reports
AJOG global reports Endocrinology, Diabetes and Metabolism, Obstetrics, Gynecology and Women's Health, Perinatology, Pediatrics and Child Health, Urology
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