NCT07751666

Active Not Recruiting

Association Between Neuraxial Labor Analgesia and Maternal a...

Peking University First Hospital Source

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Other study identifiers

Sponsor study identifier

2026R0399

Study Type

observational

Estimated enrollment

49,000

Locations

0 countries

Sites

N/A

Timeline

Study Start

January 1, 2015

Actual (reported)

Primary Completion

December 31, 2022

Actual (reported)

Study Completion

May 31, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: active not recruiting
Estimated enrollment: 49,000 participants
Study completion date: May 31, 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 1, 2015
Actual (reported)
Primary Completion
December 31, 2022
Actual (reported)
First Submitted
July 23, 2026
Actual (reported)
First Posted
August 7, 2026
Actual (reported)
Study Completion
May 31, 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: August 7, 2026
Status Verified: July 2026
Last Update Submitted: August 5, 2026

Conditions

Clinical Chorioamnionitis Intrapartum Maternal Fever Neonatal Infection

Keywords

Neonatal infectionClinical chorioamnionitisIntrapartum maternal feverNeuraxial 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 analgesiaProcedure

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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;

Sponsors & Collaborators

Peking University First Hospital
Otherlead

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

Actual (reported)

Primary Completion

December 31, 2022

Actual (reported)

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Phase 3Completed

NCT03371056

Maternal- Fetal Infection

Not ApplicableCompleted

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Immediate Versus Delayed Induction in Term-PROM Using or Not Antibiotic Prophylaxis

Not ApplicableUnknown

NCT02486783

Infection, Sepsis and Meningitis in Surinamese Neonates

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NCT03251898

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Completed

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.

Contact the study team to confirm eligibility.

Study Completion

May 31, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

August 7, 2026

Record last verified: 2026-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07751666
Data provider: ClinicalTrials.gov
Source updated: 2026-08-07
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:48 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

exposed group

unexposed group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Design

Study Record Dates

You may not qualify if:

Source record