MedPath

Evaluation of the Risk of Infection During Fever in Labor

Recruiting
Conditions
Labor
Fever
Interventions
Other: Non applicable
Registration Number
NCT06517290
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
600
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.
Read More
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
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
ChildNon applicable-
Fever during laborNon applicable-
Primary Outcome Measures
NameTimeMethod
Percentage of proven maternal bacterial infectionsUp to 6 months

(non-obstetric, intrauterine, endometritis)

Percentage of maternal-fetal infectionsUp to 6 months

intrauterine infection possibly responsible for early neonatal bacterial infection (proven or probable), endometritis, maternal sepsis

Percentage of proven and probable early neonatal infectionsUp to 6 months
Secondary Outcome Measures
NameTimeMethod
occurrence of endometritisUp to 6 months

Maternal and neonatal prognosis

Occurrence of maternal sepsisUp to 6 months

Maternal and neonatal prognosis

Occurrence of serious accident III or IV linked to the prescription of antibioticsUp to 6 months

Maternal and neonatal prognosis

occurrence of proven or probable early neonatal infectionUp to 6 months

Maternal and neonatal prognosis

Percentage of antibiotic therapyUp to 6 months

Type of care by category

Trial Locations

Locations (3)

APHP - Trousseau Hospital - Gynecology-Obstetrics-Maternity

🇫🇷

Paris, IDF, France

AP-HP - Cochin Hospital - Maternity

🇫🇷

Paris, IDF, France

APHP - Necker Hospital - Maternity

🇫🇷

Paris, IDF, France

© Copyright 2025. All Rights Reserved by MedPath