Evaluation of the Risk of Infection During Fever in Labor (FEVERY)

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Fever

Labor

Treatments

Other: Non applicable

Study type

Observational

Funder types

Other

Identifiers

NCT06517290

APHP240875

Details and patient eligibility

About

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.

Full description

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

Fever indicative of maternofetal infection: potentially early intrauterine infection leading to proven or probable early-onset neonatal bacterial infection, endometritis, or maternal sepsis.
Fever indicative of maternal infectious pathology outside the obstetrical field (e.g., pyelonephritis, influenza, COVID, etc.).
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.

Enrollment

422 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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