Evaluation of the Risk of Infection During Fever in Labor

NCT ID: NCT06517290

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 422 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-08
• Study Completion Date: 2025-05-05

Brief Summary

• Fever during labor affects more than 8% of parturients. It is a heterogeneous entity and can be due to an infectious process, a side effect of a drug, or to labor itself (physiological hyperthermia).
• It has been the subject of several retrospective studies and a few prospective studies with varying methodologies, definitions, and inclusion criteria. None have proposed a combined obstetric, neonatal, infectious disease, and microbiological analysis.
• It raises concerns about the possibility of an emerging maternal (obstetric or otherwise) and/or fetal infection.
• Analysis of the available literature does not clarify the exact frequency of these infections or the predictive factors for their occurrence.
• It often justifies systemic antibiotic therapy, the modalities and benefits of which have never been evaluated.

The investigators aim to conduct a prospective multicenter study to analyze fever during labor with a combined obstetric, infectious disease, pediatric, and microbiological perspective.

Detailed Description

The primary objective of this study is to analyze the causes of fever during labor by categorizing them into 3 etiological categories:

1. Fever indicative of maternofetal infection: potentially early intrauterine infection leading to proven or probable early-onset neonatal bacterial infection, endometritis, or maternal sepsis.

2. Fever indicative of maternal infectious pathology outside the obstetrical field (e.g., pyelonephritis, influenza, COVID, etc.).

3. Fever of non-infectious origin.

Secondary objectives include:

• Describing the epidemiology and local ecology of bacterial infections.
• Identifying predictive factors for each category (obstetrical infection, non-obstetrical infection, and non-infectious fever) when fever occurs during labor.
• Evaluating the maternal and neonatal prognosis of mother-child pairs who do not receive antibiotic treatment according to local protocols (e.g., in cases of fever below a threshold value).

Depending on the results and sample size, the study will also attempt to evaluate the maternal and neonatal prognosis of mother-child pairs in cases where fever is attributed to maternofetal infectious causes (category 1) according to the antibiotic management strategy for fever during labor at each center.

Conditions

Fever; Labor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Fever during labor

Non applicable

Intervention Type: OTHER

Non applicable

Child

Non applicable

Intervention Type: OTHER

Non applicable

Interventions

Non applicable

Non applicable

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Pregnant women at least more than 37 weeks
• Who have not opposed the collection of their health data for the purposes of studies and analyzes
• In work between 07/01/2023 and 06/01/2024
• Admitted to the work room at Port Royal, Necker Sick Children or Trousseau
• With fever defined as a tympanic temperature > 38°C at least 2 times at 10 min intervals during labor.

Exclusion Criteria

• Pregnant women :
• < 37NT
• express their opposition to the collection of their data for research purposes
• minors or under legal protection
• context of medical termination of pregnancy or fetal death

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline CHARLIER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Infectious diseases department of Cochin hospital

Locations

APHP - Trousseau Hospital - Gynecology-Obstetrics-Maternity

Paris, IDF, France

AP-HP - Cochin Hospital - Maternity

Paris, IDF, France

APHP - Necker Hospital - Maternity

Paris, IDF, France

Countries

France

Other Identifiers

APHP240875

Identifier Type: -

Identifier Source: org_study_id