ClinicalTrials.gg
Active, not recruitingNCT07751666Updated Aug 7, 2026

Association Between Neuraxial Labor Analgesia and Maternal and Neonatal Infectious Outcomes

An observational study in Intrapartum Maternal Fever, Clinical Chorioamnionitis and Neonatal Infection, sponsored by Peking University First Hospital. Active, not recruiting. Open to female participants. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Peking University First Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
49,000
Sex
Female
01

Study 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.

02

Conditions studied

  • Intrapartum Maternal Fever
  • Clinical Chorioamnionitis
  • Neonatal Infection

Keywords

  • Neonatal infection
  • Clinical chorioamnionitis
  • Intrapartum maternal fever
  • Neuraxial Labor Analgesia
03

In context

Chorioamnionitis

39 studies on the registry are indexed under Chorioamnionitis; 9 are open to participants now.

This study's planned enrollment of 49,000 is above the median of 125 across 14 observational studies indexed under Chorioamnionitis.

Browse Chorioamnionitis studies →

Lead sponsor

Peking University First Hospital is the lead sponsor of 390 studies on the registry; 186 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
49,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Procedureneuraxial labor analgesia

    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.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2015 to primary completion in Dec 2022, 95 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2026
First posted
Aug 7, 2026
StartActual
Jan 1, 2015
Primary completionActual
Dec 31, 2022
CompletionEst.
May 31, 2027
Last update
Aug 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07751666
Responsible party
Jiahui Ma (Associate Research Fellow, Peking University First Hospital) — Principal investigator
First posted
Aug 7, 2026
Start date
Jan 1, 2015
Primary completion
Dec 31, 2022
Completion
May 31, 2027 (estimated)
Last update
Aug 7, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion