Association Between Neuraxial Labor Analgesia and Maternal and Neonatal Infectious Outcomes

N/AActive Not RecruitingNCT07751666

Peking University First Hospital49,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

49,000

Conditions

Intrapartum Maternal Fever Clinical Chorioamnionitis Neonatal Infection

Interventions

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Composite outcome of neonatal infection

Neonatal sepsis, pneumonia, necrotizing enterocolitis (NEC), or unspecified site infection documented during postnatal hospitalization.

Time frame: From birth until neonatal hospital discharge, assessed up to 90 days after birth