Fever; Due to HeatNCT04164875
Fever During Labour
An observational study of Fever; Due to Heat and Infection, run by Herlev Hospital at 1 site in Denmark.
Trial summary
Pilot study to assess fever during labour. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Fever; Due to Heat, Infection
- What is being tested?
- Temperature measurement
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Nov 2021to 30 Aug 2023
- How long will I take part?
- 2 Weeks
- 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 to 90 years
- Women only
- Adult, Older adult
Study population: Pregnant women.
Who may be able to join
- Age > 18 years, planned vaginal birth, able to give consent
Who cannot join
- do not speak Danish or English, unable to cooperate to rectal temperature measurements,
Trial locations and contacts
1 site in 1 country.
About this study
Pilot study to assess fever during labour.
Read the detailed description
200 parturients will be monitored for fever during labour using rectal thermometer.
Repeated measurements 1/hr during the first 6 hours will allow us to find patients developing fever.
Fever = rectal temp >38 Celsius twice within 60 min or 39 degrees Celsius measured once .
After birth, blood samples are assessed for infection. Use of Antibiotics and other medication is Recorded. Subgroup analyses based on suspected causes of fever during birth.
- Conditions
- Fever; Due to Heat, Infection
- Being tested
- Temperature measurement
- Keywords
- fever, epidural, birth, labour
- Medical subject headings
- Fever, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temperature measurementDiagnostic test
Also called Fever
The 'intervention' is repeated rectal temperature measurements
What is being measured
The primary outcome is the main question the study is designed to answer.
Fever
Fever = rectal temp >38 Celsius twice within 60 minutes or 39 degrees Celsius measured once
Measured: during labour
Secondary outcomes (4)
CRP
infection marker
Measured: 24 hours
Leucocytosis
infection marker
Measured: 24 hours
bacterial growth blood
infection marker
Measured: 1 week
bacterial growth placenta blood
infection marker
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start15 Nov 2021 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fever; Due to HeatStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Wildgaard, MD, Herlev Hospital
- Investigators
- Kim Wildgaard, MD phd, Study chair, Herlev Hospital, Afdeling for Bedøvelse og OperationLærke Vinberg Rasmussen, Principal investigator, Herlev Hospital, Dept. of Obstetriscs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164875
- Sponsor's protocol ID
- 2019 Fever during Labour
- Status last verified
- Aug 2021
- First submitted
- 13 Nov 2019
- Last updated
- 26 Aug 2021
- 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 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fever During Labour
- ClinicalTrials.gov ID
- NCT04164875
- Acronym / sponsor ID
- 2019 Fever during Labour
- Conditions
- Fever; Due to Heat, Infection
- Keywords
- fever, epidural, birth, labour
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 15 Nov 2021 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 15 Nov 2019 (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.
Pilot study to assess fever during labour.
Detailed description
200 parturients will be monitored for fever during labour using rectal thermometer.
Repeated measurements 1/hr during the first 6 hours will allow us to find patients developing fever.
Fever = rectal temp >38 Celsius twice within 60 min or 39 degrees Celsius measured once .
After birth, blood samples are assessed for infection. Use of Antibiotics and other medication is Recorded. Subgroup analyses based on suspected causes of fever during birth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Pregnant women.
Key inclusion criteria (1 listed)
- Age > 18 years, planned vaginal birth, able to give consent
Key exclusion criteria (1 listed)
- do not speak Danish or English, unable to cooperate to rectal temperature measurements,
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 |
|---|---|---|
| Temperature measurementAlso: FeverThe 'intervention' is repeated rectal temperature measurements | Diagnostic test | – |
Primary outcome
Fever
Time frame: during labour
Fever = rectal temp >38 Celsius twice within 60 minutes or 39 degrees Celsius measured once
4 secondary outcomes
CRP
Time frame: 24 hours
Leucocytosis
Time frame: 24 hours
bacterial growth blood
Time frame: 1 week
bacterial growth placenta blood
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Individual participant dataSharing planned: No
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.
Kim Wildgaard, MD phd study chair
Herlev Hospital, Afdeling for Bedøvelse og Operation
Lærke Vinberg Rasmussen principal investigator
Herlev Hospital, Dept. of Obstetriscs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever; Due to Heat and Infection, run by Herlev Hospital at 1 site in Denmark.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kim Wildgaarf, md, phd (38682170, kim.wildgaard@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fever (time frame: during labour). 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 26 Aug 2021.