Association Between Neuraxial Labor Analgesia and Maternal and Neonatal Infectious Outcomes

NCT07751666 | Active Not Recruiting DMC

• 1 other identifier: 2026R0399
• Study Type: observational
• Target: 49,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Intrapartum Maternal Fever; Clinical Chorioamnionitis; Neonatal Infection

Keywords

Neonatal infection; Clinical chorioamnionitis; Intrapartum maternal fever; Neuraxial Labor Analgesia

Outcome Measures

Primary Outcomes (1)

• Composite outcome of neonatal infection

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

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

Study Arms (2)

exposed group

Mothers and their neonates who received neuraxial labor analgesia

Procedure: neuraxial labor analgesia

unexposed group

Mothers and their neonates who didn't receive neuraxial labor analgesia

Interventions

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.

exposed group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study participants consisted of parturients and their neonates who delivered at Peking University First Hospital between January 1, 2015 and December 31, 2022.

You may qualify if:

• 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.

You may not qualify if:

• Multiple pregnancy, fetal death or stillbirth;
• Missing data on labor analgesia exposure;
• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Fellow

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 7, 2026
• Study Start: January 1, 2015
• Primary Completion: December 31, 2022
• Study Completion (Estimated): May 31, 2027
• Last Updated: August 7, 2026

Record last verified: 2026-07