FeverFEVERYNCT06517290
Evaluation of the Risk of Infection During Fever in Labor
An observational study of Fever and Labor, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Non applicable
- How many people
- 422 participants
- Where
- 3 sitesFrance
- Study dates
- 8 Aug 2024to 5 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women admitted to any of the three public university hospitals in Paris namely Port Royal, Necker - enfants maladies, Trousseau (AP-HP).
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
APHP - Trousseau Hospital - Gynecology-Obstetrics-Maternity
Paris, IDF, 75012
AP-HP - Cochin Hospital - Maternity
Paris, IDF, 75014
APHP - Necker Hospital - Maternity
Paris, IDF, 75015
About this study
- 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.
Read the detailed description
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.
- Being tested
- Non applicable
- Keywords
- Fever, Labor, Puerpueral infection, Anti-Bacterial Agents
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non applicableOther
Non applicable
| Study group | Role | What they receive |
|---|---|---|
| Fever during labor | Not described Receives: Other: Non applicable | |
| Child | Not described Receives: Other: Non applicable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of maternal-fetal infections
intrauterine infection possibly responsible for early neonatal bacterial infection (proven or probable), endometritis, maternal sepsis
Measured: Up to 6 months
Percentage of proven maternal bacterial infections
(non-obstetric, intrauterine, endometritis)
Measured: Up to 6 months
Percentage of proven and probable early neonatal infections
Measured: Up to 6 months
Secondary outcomes (5)
occurrence of proven or probable early neonatal infection
Maternal and neonatal prognosis
Measured: Up to 6 months
occurrence of endometritis
Maternal and neonatal prognosis
Measured: Up to 6 months
Occurrence of maternal sepsis
Maternal and neonatal prognosis
Measured: Up to 6 months
Occurrence of serious accident III or IV linked to the prescription of antibiotics
Maternal and neonatal prognosis
Measured: Up to 6 months
Percentage of antibiotic therapy
Type of care by category
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start8 Aug 2024
- Primary completion5 May 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Caroline CHARLIER, MD, PhD, Principal investigator, Infectious diseases department of Cochin hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517290
- Sponsor's protocol ID
- APHP240875
- Acronym
- FEVERY
- Status last verified
- Sep 2025
- First submitted
- 18 Jul 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Risk of Infection During Fever in Labor
- ClinicalTrials.gov ID
- NCT06517290
- Acronym / sponsor ID
- FEVERY / APHP240875
- Keywords
- Fever, Labor, Puerpueral infection, Anti-Bacterial Agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fever during labor | – | Other: Non applicable |
| Child | – | Other: Non applicable |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women admitted to any of the three public university hospitals in Paris namely Port Royal, Necker - enfants maladies, Trousseau (AP-HP).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non applicableNon applicable | Other | Child, Fever during labor |
Primary outcome
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
Percentage of proven maternal bacterial infections
Time frame: Up to 6 months
(non-obstetric, intrauterine, endometritis)
Percentage of proven and probable early neonatal infections
Time frame: Up to 6 months
5 secondary outcomes
occurrence of proven or probable early neonatal infection
Time frame: Up to 6 months
occurrence of endometritis
Time frame: Up to 6 months
Occurrence of maternal sepsis
Time frame: Up to 6 months
Occurrence of serious accident III or IV linked to the prescription of antibiotics
Time frame: Up to 6 months
Percentage of antibiotic therapy
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline CHARLIER, MD, PhD principal investigator
Infectious diseases department of Cochin hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever and Labor, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of maternal-fetal infections (time frame: Up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.