NCT06517290

Evaluation of the Risk of Infection During Fever in Labor

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 422 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Non applicable	Non applicable

Timeline

• Start date: 2024-08-08
• Primary completion: 2025-05-05
• Completion: 2025-05-05
• First posted: 2024-07-24
• Last updated: 2025-09-15

Locations

3 sites across 1 country: France