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Association Between Neuraxial Labor Analgesia and Maternal and Neonatal Infectious Outcomes

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07751666
Enrollment
49000
Registered
2026-08-07
Start date
2015-01-01
Completion date
2027-05-31
Last updated
2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Chorioamnionitis, Intrapartum Maternal Fever, Neonatal Infection

Keywords

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

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.

Interventions

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.

Sponsors

Peking University First Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Composite outcome of neonatal infectionFrom birth until neonatal hospital discharge, assessed up to 90 days after birthNeonatal sepsis, pneumonia, necrotizing enterocolitis (NEC), or unspecified site infection documented during postnatal hospitalization.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026