Association Between Neuraxial Labor Analgesia and Maternal and Neonatal Infectious Outcomes: A Retrospective Cohort Study Using a Single-Center Delivery Database
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 49,000
- 主要终点
- Composite outcome of neonatal infection
研究概览
简要总结
The goal of this retrospective observational cohort study is to explore the associations between neuraxial labor analgesia and maternal-neonatal infectious outcomes among women attempting vaginal delivery, and to distinguish genuine infectious risks from clinical fever-related diagnostic and treatment pathways. The main question it aims to answer is:
Does neuraxial labor analgesia increase the risk of composite neonatal infectious outcomes in singleton live birth women attempting vaginal delivery? Participants who met inclusion criteria with clear neuraxial labor analgesia exposure status (exposed group receiving neuraxial labor analgesia during labor; unexposed group without such analgesia) were extracted from the hospital's delivery database covering 2015 to 2022, and their pre-delivery baseline characteristics, labor course records, maternal fever, intrapartum antibiotic administration, clinical chorioamnionitis diagnosis and neonatal infectious diagnosis data were retrospectively analyzed via multiple statistical adjustment approaches including propensity score weighting, sensitivity analysis and negative control analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Delivery year ranging from 2015 to 2022;
- •Singleton pregnancy with live birth;
- •Records of labor induction or spontaneous uterine contraction documented in the database, consistent with the definition of planned or attempted vaginal delivery;
- •Clear documentation of exposure status to labor analgesia;
- •Availability of key baseline covariates including maternal age and gestational age.
排除标准
- •Multiple pregnancy, fetal death or stillbirth;
- •Missing data on labor analgesia exposure;
- •Unavailable key baseline data, precluding inclusion in the primary adjusted model;
- •Missing database entries for spontaneous uterine contraction or labor induction; such cases were excluded from the primary target cohort, as they were more likely to represent elective cesarean delivery or unplanned vaginal delivery.
研究组 & 干预措施
exposed group
Mothers and their neonates who received neuraxial labor analgesia
干预措施: neuraxial labor analgesia (Procedure)
unexposed group
Mothers and their neonates who didn't receive neuraxial labor analgesia
结局指标
主要结局
Composite outcome of neonatal infection
时间窗: From birth until neonatal hospital discharge, assessed up to 90 days after birth
Neonatal sepsis, pneumonia, necrotizing enterocolitis (NEC), or unspecified site infection documented during postnatal hospitalization.
次要结局
未报告次要终点
研究者
Jiahui Ma
Associate Research Fellow
Peking University First Hospital