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Completed

NCT Number: NCT06517290

Evaluation of the Risk of Infection During Fever in Labor

* 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

AP-HP - Cochin Hospital - Maternity, Paris, IDF, France

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About this study

The primary objective of this study is to analyze the causes of fever during labor by categorizing them into 3 etiological categories:

  • Fever indicative of maternofetal infection: potentially early intrauterine infection leading to proven or probable early-onset neonatal bacterial infection, endometritis, or maternal sepsis.
  • Fever indicative of maternal infectious pathology outside the obstetrical field (e.g., pyelonephritis, influenza, COVID, etc.).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non applicable

Other

Non applicable

Primary outcomes

  1. Percentage of maternal-fetal infections

    Time frame: Up to 6 months

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

  2. Percentage of proven maternal bacterial infections

    Time frame: Up to 6 months

    (non-obstetric, intrauterine, endometritis)

  3. Percentage of proven and probable early neonatal infections

    Time frame: Up to 6 months

Secondary outcomes

  1. occurrence of proven or probable early neonatal infection

    Time frame: Up to 6 months

    Maternal and neonatal prognosis

  2. occurrence of endometritis

    Time frame: Up to 6 months

    Maternal and neonatal prognosis

  3. Occurrence of maternal sepsis

    Time frame: Up to 6 months

    Maternal and neonatal prognosis

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

    Time frame: Up to 6 months

    Maternal and neonatal prognosis

  5. Percentage of antibiotic therapy

    Time frame: Up to 6 months

    Type of care by category

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: FEVERY

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2024
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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