Evaluating the causes of fever during labor
Evaluation of the Risk of Infection During Fever in Labor
This study is trying to find out what causes fever in pregnant women during labor to help improve care for both mothers and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 3 sites (Paris, IDF and 2 other locations) |
| Trial ID | NCT06517290 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the causes of fever in pregnant women during labor by categorizing them into three etiological groups: infections related to maternal-fetal conditions, infections unrelated to obstetrics, and non-infectious causes. The study will be conducted across multiple centers and will involve a prospective analysis of fever occurrences, their predictive factors, and the maternal and neonatal outcomes associated with different management strategies. By combining obstetric, infectious disease, pediatric, and microbiological perspectives, the study seeks to clarify the frequency and implications of fever during labor.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women over 37 weeks gestation who experience fever during labor.
Not a fit: Patients who are under 37 weeks gestation or those who oppose the collection of their health data will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding and management of fever during labor, potentially reducing unnecessary antibiotic use and improving maternal and neonatal outcomes.
How similar studies have performed: While there have been retrospective studies on this topic, this study's comprehensive prospective approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris, IDF and 2 other locations
- APHP - Trousseau Hospital - Gynecology-Obstetrics-Maternity — Paris, Idf, France (Not_yet_recruiting)
- AP-HP - Cochin Hospital - Maternity — Paris, Idf, France (Recruiting)
- APHP - Necker Hospital - Maternity — Paris, Idf, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Caroline CHARLIER, MD, PhD — Infectious diseases department of Cochin hospital
- Study coordinator: Chemsa LE COEUR, MD
- Email: chemsa.lecoeur@aphp.fr
- Phone: 00331 58 41 41 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.