Clinical trial NCT06517290: Evaluation of the Risk of Infection During Fever in Labor
Official title: Evaluation of the Risk of Infection During Fever in Labor
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fever
Labor
Keywords: Fever
Labor
Puerpueral infection
Anti-Bacterial Agents
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women admitted to any of the three public university hospitals in Paris namely Port Royal, Necker - enfants maladies, Trousseau (AP-HP).

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.

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

Primary outcomes:
measure: Percentage of maternal-fetal infections
timeFrame: Up to 6 months
measure: Percentage of proven maternal bacterial infections
timeFrame: Up to 6 months
measure: Percentage of proven and probable early neonatal infections
timeFrame: Up to 6 months
Secondary outcomes:
measure: occurrence of proven or probable early neonatal infection
timeFrame: Up to 6 months
measure: occurrence of endometritis
timeFrame: Up to 6 months
measure: Occurrence of maternal sepsis
timeFrame: Up to 6 months
measure: Occurrence of serious accident III or IV linked to the prescription of antibiotics
timeFrame: Up to 6 months
measure: Percentage of antibiotic therapy
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: APHP - Trousseau Hospital - Gynecology-Obstetrics-Maternity
state: IDF
city: Paris
country: France
facility: AP-HP - Cochin Hospital - Maternity
state: IDF
city: Paris
country: France
facility: APHP - Necker Hospital - Maternity
state: IDF
Study officials:
affiliation: Infectious diseases department of Cochin hospital
name: Caroline CHARLIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: