引产标准化方案：一项I型有效性-实施混合型试验。
Standardized protocol for labor induction: a type I hybrid effectiveness-implementation trial.
作者信息
Hamm Rebecca F, Benny Janice, Beidas Rinad S, Morales Knashawn H, Srinivas Sindhu K, Parry Samuel, Levine Lisa D
机构信息
Department of Obstetrics & Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
Leonard Davis Institute of Health Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
出版信息
Lancet Reg Health Am. 2024 Dec 10;41:100956. doi: 10.1016/j.lana.2024.100956. eCollection 2025 Jan.
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.
背景
剖宫产仍然是最常见的产科手术，在美国，每年有超过25万名患者在引产术后接受剖宫产。在此，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
这项多中心I型混合有效性-实施研究比较了宾夕法尼亚大学医疗系统内两家医院在实施标准化引产方案之前（PRE，2018 - 2022年）和之后（POST，2018 - 2022年）的两年情况。该方案包括多个组成部分，并推荐对引产进行积极管理，包括频繁的宫颈检查、宫颈检查≥4厘米时行羊膜穿刺术以及对产程异常的干预措施。主要有效性结局是剖宫产。次要有效性结局包括产程长度、绒毛膜羊膜炎以及母婴发病率。主要实施结局是依从性，定义为在8个可单独评估的方案组成部分中，遵守≥75%的组成部分。所有数据通过个体病历审查收集。
研究结果
纳入8509例患者（PRE组：n = 4214，POST组：n = 4295）。我们的研究人群年龄中位数为31岁，四分位间距（IQR）为[26 - 35]岁，44.6%为黑人，40.1%为白人，6.9%为亚洲人，8.4%为其他或不明种族；7.4%的人群为拉丁裔。总体而言，两个时间段的剖宫产率无显著差异（PRE组：21.6% vs. POST组：21.8%，p = 0.85；调整相对风险（aRR）0.99，95%置信区间（CI）[0.90 - 1.09]）。产程长度、绒毛膜羊膜炎或综合新生儿发病率也无显著差异。产妇发病率从PRE组到POST组有所下降（PRE组：9.3% vs. POST组：6.5%，p < 0.001；aRR 0.67，95% CI [0.58 - 0.79]）。实施后，遵守≥75%方案组成部分的引产增加（PRE组：52.4% vs. POST组：59.6%，p < 0.001），表现为更频繁的宫颈检查、羊膜穿刺术时更早的宫颈扩张以及增加的产程异常管理。
解读
尽管标准化引产管理有所增加，但剖宫产率并未发现显著差异。
资助
美国国立儿童健康与人类发展研究所K23HD102523。
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