Evaluation of the Risk of Infection During Fever in Labor

NCT06517290 | Completed

• 1 other identifier: APHP240875
• Study Type: observational
• Target: 422
• Locations: 1 country
• Sites: 3

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.

Conditions

Fever; Labor

Keywords

Fever; Labor; Puerpueral infection; Anti-Bacterial Agents

Outcome Measures

Primary Outcomes (3)

• Percentage of maternal-fetal infections

  intrauterine infection possibly responsible for early neonatal bacterial infection (proven or probable), endometritis, maternal sepsis

  Up to 6 months

• Percentage of proven maternal bacterial infections

  (non-obstetric, intrauterine, endometritis)

  Up to 6 months

• Percentage of proven and probable early neonatal infections

  Up to 6 months

Secondary Outcomes (5)

• occurrence of proven or probable early neonatal infection

  Up to 6 months

• occurrence of endometritis

  Up to 6 months

• Occurrence of maternal sepsis

  Up to 6 months

• Occurrence of serious accident III or IV linked to the prescription of antibiotics

  Up to 6 months

• Percentage of antibiotic therapy

  Up to 6 months

Study Arms (2)

Fever during labor

Other: Non applicable

Child

Other: Non applicable

Interventions

Non applicable OTHER

Non applicable

Child; Fever during labor

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (3)

APHP - Trousseau Hospital - Gynecology-Obstetrics-Maternity

Paris, IDF, 75012, France

Location

AP-HP - Cochin Hospital - Maternity

Paris, IDF, 75014, France

Location

APHP - Necker Hospital - Maternity

Paris, IDF, 75015, France

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Caroline CHARLIER, MD, PhD

  Infectious diseases department of Cochin hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: August 8, 2024
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)