Fever During Labour

August 25, 2021 updated by: Kim Wildgaard, MD, Herlev Hospital
Pilot study to assess fever during labour.

Study Overview

Status

Not yet recruiting

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

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Herlev, Denmark, 2730
        • Department of Anaesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 15, 2021

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

August 30, 2023

Study Registration Dates

First Submitted

November 13, 2019

First Submitted That Met QC Criteria

November 13, 2019

First Posted (Actual)

November 15, 2019

Study Record Updates

Last Update Posted (Actual)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

August 1, 2021

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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