Skip to content

Evaluation of the Risk of Infection During Fever in Labor

Evaluation of the Risk of Infection During Fever in Labor

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06517290
Acronym
FEVERY
Enrollment
422
Registered
2024-07-24
Start date
2024-08-08
Completion date
2025-05-05
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever, Labor

Keywords

Fever, Labor, Puerpueral infection, Anti-Bacterial Agents

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.

Interventions

Non applicable

Sponsors

URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of maternal-fetal infectionsUp to 6 monthsintrauterine infection possibly responsible for early neonatal bacterial infection (proven or probable), endometritis, maternal sepsis
Percentage of proven maternal bacterial infectionsUp to 6 months(non-obstetric, intrauterine, endometritis)
Percentage of proven and probable early neonatal infectionsUp to 6 months

Secondary

MeasureTime frameDescription
Occurrence of serious accident III or IV linked to the prescription of antibioticsUp to 6 monthsMaternal and neonatal prognosis
occurrence of proven or probable early neonatal infectionUp to 6 monthsMaternal and neonatal prognosis
Percentage of antibiotic therapyUp to 6 monthsType of care by category
occurrence of endometritisUp to 6 monthsMaternal and neonatal prognosis
Occurrence of maternal sepsisUp to 6 monthsMaternal and neonatal prognosis

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026