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NCT04164875 Clinical Trial

Fever During Labour

Infection Clinical Trial

Official title:
Fever During Labour

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04164875
Other study ID # 2019 Fever during Labour
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 15, 2021
Est. completion date August 30, 2023

Study information
Verified date August 2021
Source Herlev Hospital
Contact Kim Wildgaarf, md, phd
Phone 38682170
Email kim.wildgaard@regionh.dk
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Pilot study to assess fever during labour.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date August 30, 2023
Est. primary completion date November 30, 2022
Accepts healthy volunteers
Gender Female
Age group 18 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Temperature measurement
The 'intervention' is repeated rectal temperature measurements

Locations
Country Name City State
Denmark Department of Anaesthesiology Herlev

Sponsors (1)
Lead Sponsor Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fever Fever = rectal temp >38 Celsius twice within 60 minutes or 39 degrees Celsius measured once during labour
Secondary CRP infection marker 24 hours
Secondary Leucocytosis infection marker 24 hours
Secondary bacterial growth blood infection marker 1 week
Secondary bacterial growth placenta blood infection marker 1 week
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