NCT04164875

Brief Summary

Pilot study to assess fever during labour.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
2 years until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

November 13, 2019

Last Update Submit

August 25, 2021

Conditions

Fever; Due to HeatInfection

Keywords

feverepiduralbirthlabour

Outcome Measures

Primary Outcomes (1)

  • Fever

    Fever = rectal temp \>38 Celsius twice within 60 minutes or 39 degrees Celsius measured once

    during labour

Secondary Outcomes (4)

  • CRP

    24 hours

  • Leucocytosis

    24 hours

  • bacterial growth blood

    1 week

  • bacterial growth placenta blood

    1 week

Interventions

Temperature measurementDIAGNOSTIC_TEST

The 'intervention' is repeated rectal temperature measurements

Also known as: Fever

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant women.

You may qualify if:

  • Age \> 18 years, planned vaginal birth, able to give consent

You may not qualify if:

  • do not speak Danish or English, unable to cooperate to rectal temperature measurements,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

FeverInfections

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kim Wildgaard, MD phd

    Herlev Hospital, Afdeling for Bedøvelse og Operation

    STUDY CHAIR

  • Lærke Vinberg Rasmussen

    Herlev Hospital, Dept. of Obstetriscs

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim Wildgaarf, md, phd

CONTACT

38682170kim.wildgaard@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, ph.d.,Clinical Professor

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 15, 2019

Study Start

November 15, 2021

Primary Completion

November 30, 2022

Study Completion

August 30, 2023

Last Updated

August 26, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)