引产标准化方案：I型混合效果-实施试验。

IF 7 Q1 HEALTH CARE SCIENCES & SERVICES

Lancet Regional Health-Americas Pub Date : 2025-01-01 DOI:10.1016/j.lana.2024.100956

Rebecca F. Hamm , Janice Benny , Rinad S. Beidas , Knashawn H. Morales , Sindhu K. Srinivas , Samuel Parry , Lisa D. Levine

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引用次数: 0

摘要

背景：剖宫产仍然是最常见的产科手术，在美国每年有超过25万患者在引产后接受剖宫产。在这里，我们评估了前瞻性实施标准化引产方案对剖宫产率的影响。方法：本多地点I型混合有效性-实施研究比较了宾夕法尼亚大学卫生系统两家医院（2018-2022）实施标准化引产方案前2年和后2年的效果。该方案包括多个组成部分，并推荐积极的引产管理，包括频繁的宫颈检查，如果宫颈检查≥4 cm则切开羊膜，以及对难产的干预。主要疗效指标为剖宫产。次要有效性指标包括产程长度、绒毛膜羊膜炎、产妇和新生儿发病率。主要的实施结局是保真度，定义为在8个可离散评估的单独组成部分中，遵守≥75%的方案组成部分。所有数据均通过个人图表审查收集。结果：纳入8509例患者（PRE: n = 4214, POST: n = 4295）。我们的人群年龄中位数为31岁[26-35]，其中44.6%为黑人，40.1%为白人，6.9%为亚洲人，8.4%为其他或未知人群；7.4%的人口是拉丁裔。两个时间段的剖宫产率总体上没有显著差异(术前：21.6% vs术后：21.8%,p = 0.85；校正相对危险度（aRR） 0.99 95%可信区间（CI）[0.90-1.09])。在产程长度、绒毛膜羊膜炎或新生儿综合发病率方面没有显著差异。产前分娩与产后分娩相比，产妇发病率降低（PRE: 9.3% vs. POST: 6.5%, p）解释：尽管标准化的诱导管理越来越多，但剖宫产的发生率没有显著差异。资助：NICHD K23HD102523。

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Standardized protocol for labor induction: a type I hybrid effectiveness-implementation trial

Background

Cesarean delivery remains the most common obstetrical procedure with more than 250,000 patients in the US undergoing cesarean following labor induction annually. Here, we evaluated the impact of prospectively implementing a standardized labor induction protocol on cesarean delivery rates.

Methods

This multi-site type I hybrid effectiveness-implementation study compared 2 years before (PRE) and 2 years after (POST) implementation of a standardized labor induction protocol at two hospitals within the University of Pennsylvania Health System (2018–2022). The protocol included multiple components and recommended active management of labor induction, including frequent cervical examinations, amniotomy if cervical exam ≥4 cm, and interventions for labor dystocia. The primary effectiveness outcome was cesarean delivery. Secondary effectiveness outcomes included labor length, chorioamnionitis, and maternal and neonatal morbidity. The primary implementation outcome was fidelity, defined as adherence to ≥75% of the protocol components among 8 individual components that could be evaluated discretely. All data was collected via individual chart review.

Findings

8509 patients were included (PRE: n = 4214, POST: n = 4295). Our population was of median age of 31 years interquartile range (IQR) [26–35], and 44.6% identified as Black, 40.1% as white, 6.9% as Asian, and 8.4% as other or unknown; 7.4% of the population identified as Latinx. There was no significant difference in cesarean delivery rate between the two time periods overall (PRE: 21.6% vs. POST: 21.8%, p = 0.85; adjusted relative risk (aRR) 0.99 95% confidence interval (CI) [0.90–1.09]). There were no significant differences in labor length, chorioamnionitis, or composite neonatal morbidity. Maternal morbidity decreased PRE to POST (PRE: 9.3% vs. POST: 6.5%, p < 0.001; aRR 0.67 95% CI [0.58–0.79]). POST-implementation, inductions with fidelity to ≥75% of protocol components increased (PRE: 52.4% vs. POST: 59.6%, p < 0.001), evidenced by more frequent cervical examinations, earlier dilation at amniotomy, and increased labor dystocia management.

Interpretation

Despite increasing standardized induction management, no significant difference in cesarean delivery was found.

Funding

NICHD K23HD102523.

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来源期刊

Lancet Regional Health-Americas Multiple-

CiteScore

8.00

自引率

0.00%

发文量

期刊介绍： The Lancet Regional Health – Americas, an open-access journal, contributes to The Lancet's global initiative by focusing on health-care quality and access in the Americas. It aims to advance clinical practice and health policy in the region, promoting better health outcomes. The journal publishes high-quality original research advocating change or shedding light on clinical practice and health policy. It welcomes submissions on various regional health topics, including infectious diseases, non-communicable diseases, child and adolescent health, maternal and reproductive health, emergency care, health policy, and health equity.