Intrapartum Maternal FeverNCT07751666
Association Between Neuraxial Labor Analgesia and Maternal and Neonatal Infectious Outcomes
An observational study of Intrapartum Maternal Fever and Clinical Chorioamnionitis, run by Peking University First Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Intrapartum Maternal Fever, Clinical Chorioamnionitis, Neonatal Infection
- What is being tested?
- neuraxial labor analgesia
- Type of treatment
- Surgery or procedure
- How many people
- 49,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Association Between Neuraxial Labor Analgesia and Maternal and Neonatal Infectious Outcomes: A Retrospective Cohort Study Using a Single-Center Delivery Database
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.
- Being tested
- neuraxial labor analgesia
- Keywords
- Neonatal infection, Clinical chorioamnionitis, Intrapartum maternal fever, Neuraxial Labor Analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuraxial labor analgesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| exposed group | Mothers and their neonates who received neuraxial labor analgesia Receives: Procedure: neuraxial labor analgesia | |
| unexposed group | Mothers and their neonates who didn't receive neuraxial labor analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome of neonatal infection
Neonatal sepsis, pneumonia, necrotizing enterocolitis (NEC), or unspecified site infection documented during postnatal hospitalization.
Measured: From birth until neonatal hospital discharge, assessed up to 90 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Jan 2015
- Primary completion31 Dec 2022
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrapartum Maternal FeverStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 49,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiahui Ma, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751666
- Sponsor's protocol ID
- 2026R0399
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Neuraxial Labor Analgesia and Maternal and Neonatal Infectious Outcomes: A Retrospective Cohort Study Using a Single-Center Delivery Database
- ClinicalTrials.gov ID
- NCT07751666
- Acronym / sponsor ID
- 2026R0399
- Keywords
- Neonatal infection, Clinical chorioamnionitis, Intrapartum maternal fever, Neuraxial Labor Analgesia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 49,000 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposed group | – | Procedure: neuraxial labor analgesiaMothers and their neonates who received neuraxial labor analgesia |
| unexposed group | – | –Mothers and their neonates who didn't receive neuraxial labor analgesia |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuraxial labor analgesiaThe studied intervention, neuraxial labor analgesia, is defined as epidural or combined spinal-epidural pain relief delivered by spinal canal puncture during active vaginal labor. | Procedure or surgery | exposed group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrapartum Maternal Fever and Clinical Chorioamnionitis, run by Peking University First Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome of neonatal infection (time frame: From birth until neonatal hospital discharge, assessed up to 90 days after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.