Association Between Neuraxial Labor Analgesia and Maternal and Neonatal Infectious Outcomes

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Intrapartum Maternal Fever Clinical Chorioamnionitis Neonatal Infection

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neuraxial labor analgesia

Procedure

The studied intervention, neuraxial labor analgesia, is defined as epidural or combined spinal-epidural pain relief delivered by spinal canal puncture during active vaginal labor.

Primary outcomes

Composite outcome of neonatal infection

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

Association Between Neuraxial Labor Analgesia and Maternal and Neonatal Infectious Outcomes: A Retrospective Cohort Study Using a Single-Center Delivery Database

Important dates

Study start: 2015
Primary completion: 2022
Study completion: 2027
First posted: Aug 7, 2026
Registry last updated: Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Active, not recruiting