Evaluation of the Risk of Infection During Fever in Labor
- Conditions
- LaborFever
- 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
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Child Non applicable - Fever during labor Non applicable -
- Primary Outcome Measures
Name Time Method Percentage of proven maternal bacterial infections Up to 6 months (non-obstetric, intrauterine, endometritis)
Percentage of maternal-fetal infections Up 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 infections Up to 6 months
- Secondary Outcome Measures
Name Time Method occurrence of endometritis Up to 6 months Maternal and neonatal prognosis
Occurrence of maternal sepsis Up to 6 months Maternal and neonatal prognosis
Occurrence of serious accident III or IV linked to the prescription of antibiotics Up to 6 months Maternal and neonatal prognosis
occurrence of proven or probable early neonatal infection Up to 6 months Maternal and neonatal prognosis
Percentage of antibiotic therapy Up 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