- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07751666
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
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.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
exposed group
Mothers and their neonates who received neuraxial 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.
|
|
unexposed group
Mothers and their neonates who didn't receive neuraxial labor analgesia
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Composite outcome of neonatal infection
Tidsramme: 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.
|
From birth until neonatal hospital discharge, assessed up to 90 days after birth
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2026R0399
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