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荷兰助产士助手在分娩期间的连续照护与常规照护的随机对照试验。

Continuous care during labor by maternity care assistants in the Netherlands vs care-as-usual: a randomized controlled trial.

机构信息

Department of Obstetrics & Gynecology, Maastricht University Medical Center, Maastricht, The Netherlands (Mses Chaibekava and Scheenan and Dr Scheepers); GROW-School for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands (Ms Chaibekava and Dr Scheepers).

Department of Obstetrics & Gynecology, Maastricht University Medical Center, Maastricht, The Netherlands (Mses Chaibekava and Scheenan and Dr Scheepers).

出版信息

Am J Obstet Gynecol MFM. 2023 Nov;5(11):101168. doi: 10.1016/j.ajogmf.2023.101168. Epub 2023 Sep 24.

Abstract

BACKGROUND

Continuous support during labor has many benefits including lower use of obstetrical interventions. However, implementation remains limited. Insights into birth outcomes and peripartum costs are essential to assess whether continuous care by a maternity care assistant is a potentially (cost) effective program to provide for all women.

OBJECTIVE

Continuous care during labor, provided by maternity care assistants, will reduce the use of epidural analgesia and peripartum costs owing to a reduction in interventions.

STUDY DESIGN

This was a randomized controlled trial comparing continuous support during labor (intervention group) with care-as-usual (control group) with prespecified intention-to-treat and per-protocol analyses. The primary outcome was epidural analgesia use. The secondary outcomes were use of other analgesia, referrals from midwife- to obstetrician-led care, modes of birth, hospital stay, sense of control (evaluated with the Labor Agentry Scale), maternal and neonatal adverse outcomes and peripartum costs. Data were collected using questionnaires. Anticipating incomplete adherence to providing continuous care, both intention-to-treat and per-protocol analyses were planned. Peripartum costs were estimated using a healthcare perspective. Mean costs per woman and cost differences between the intervention and control group were calculated.

RESULTS

The population consisted of 1076 women with 54 exclusions and 30 discontinuations, leaving 992 women to be analyzed (515 continuous care and 477 care-as-usual). Intention-to-treat analyses showed statistically nonsignificant differences between the intervention and control group for epidural use (relative risk, 0.88; 95% confidence interval, 0.74-1.04; P=.14) and peripartum costs (mean difference, € 185.83; 95% confidence interval, -€ 204.22 to € 624.54). Per-protocol analyses showed statistically significant decreases in epidural analgesia (relative risk, 0.64; 95% confidence interval, 0.48-0.84; P=.001), other analgesia (relative risk, 0.59; 95% confidence interval, 0.37-0.94; P=.02), cesarean deliveries (relative risk, 0.53; 95% confidence interval, 0.29-0.95; P=.03) and increase in spontaneous vaginal births (relative risk, 1.09; 95% confidence interval, 1.01-1.18; P=.001) in the intervention group, but difference in total peripartum costs remained statistically nonsignificant (mean difference, € 246.55; 95% confidence interval, -€ 539.14 to € 13.50).

CONCLUSION

If the provision of continuous care given by maternity care assistants during labor can be secured, continuous care leads to more vaginal births and less epidural use, pain medication, and cesarean deliveries while not leading to a difference in peripartum costs compared with care-as-usual.

摘要

背景

分娩过程中的持续支持有许多益处,包括降低产科干预的使用。然而,实施仍然有限。了解分娩结果和围产期成本对于评估由助产士助理提供的连续护理是否是为所有女性提供潜在(成本)有效的计划至关重要。

目的

由助产士助理提供的分娩过程中的持续护理将减少硬膜外镇痛的使用和围产期成本,因为干预措施减少了。

研究设计

这是一项随机对照试验,比较了分娩过程中的持续支持(干预组)与常规护理(对照组),并进行了预设的意向治疗和方案分析。主要结局是硬膜外镇痛的使用。次要结局是其他镇痛的使用、从中助产士主导的护理转为产科医生主导的护理的转诊、分娩方式、住院时间、控制感(用分娩代理量表评估)、母婴不良结局和围产期成本。数据通过问卷调查收集。预计对提供持续护理的不完全遵守,因此计划了意向治疗和方案分析。围产期成本是从医疗保健的角度进行估算的。计算了每位女性的平均成本和干预组与对照组之间的成本差异。

结果

该人群包括 1076 名女性,其中 54 人被排除在外,30 人中途退出,留下 992 名女性进行分析(515 名接受持续护理,477 名接受常规护理)。意向治疗分析显示,干预组和对照组在硬膜外使用(相对风险,0.88;95%置信区间,0.74-1.04;P=.14)和围产期成本(平均差异,€185.83;95%置信区间,€204.22 至 €624.54)方面差异无统计学意义。方案分析显示,硬膜外镇痛(相对风险,0.64;95%置信区间,0.48-0.84;P=.001)、其他镇痛(相对风险,0.59;95%置信区间,0.37-0.94;P=.02)、剖宫产(相对风险,0.53;95%置信区间,0.29-0.95;P=.03)和自然阴道分娩(相对风险,1.09;95%置信区间,1.01-1.18;P=.001)的发生率在干预组中显著降低,但总围产期成本差异仍无统计学意义(平均差异,€246.55;95%置信区间,€539.14 至 €13.50)。

结论

如果能确保在分娩过程中由助产士助理提供持续护理,那么与常规护理相比,持续护理会导致更多的阴道分娩和更少的硬膜外使用、疼痛药物和剖宫产,而不会导致围产期成本的差异。

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