- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04164875
Fever During Labour
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Kim Wildgaarf, md, phd
- Phone Number: 38682170
- Email: kim.wildgaard@regionh.dk
Study Locations
-
-
-
Herlev, Denmark, 2730
- Department of Anaesthesiology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 18 years, planned vaginal birth, able to give consent
Exclusion Criteria:
- do not speak Danish or English, unable to cooperate to rectal temperature measurements,
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fever
Time Frame: during labour
|
Fever = rectal temp >38 Celsius twice within 60 minutes or 39 degrees Celsius measured once
|
during labour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CRP
Time Frame: 24 hours
|
infection marker
|
24 hours
|
Leucocytosis
Time Frame: 24 hours
|
infection marker
|
24 hours
|
bacterial growth blood
Time Frame: 1 week
|
infection marker
|
1 week
|
bacterial growth placenta blood
Time Frame: 1 week
|
infection marker
|
1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Kim Wildgaard, MD phd, Herlev Hospital, Afdeling for Bedøvelse og Operation
- Principal Investigator: Lærke Vinberg Rasmussen, Herlev Hospital, Dept. of Obstetriscs
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019 Fever during Labour
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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