Fever During Labour
Sponsor
Herlev Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04164875
Collaborator
(none)
200
1
21.5
9.3
Study Details
Study Description
Brief Summary
Pilot study to assess fever during labour.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Fever During Labour
Anticipated Study Start Date
:
Nov 15, 2021
Anticipated Primary Completion Date
:
Nov 30, 2022
Anticipated Study Completion Date
:
Aug 30, 2023
Outcome Measures
Primary Outcome Measures
- Fever [during labour]
Fever = rectal temp >38 Celsius twice within 60 minutes or 39 degrees Celsius measured once
Secondary Outcome Measures
- CRP [24 hours]
infection marker
- Leucocytosis [24 hours]
infection marker
- bacterial growth blood [1 week]
infection marker
- bacterial growth placenta blood [1 week]
infection marker
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 90 Years
Sexes Eligible for Study:
Female
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,
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Anaesthesiology | Herlev | Denmark | 2730 |
Sponsors and Collaborators
- Herlev Hospital
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 Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Kim Wildgaard, MD,
MD, ph.d.,Clinical Professor,
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT04164875
Other Study ID Numbers:
- 2019 Fever during Labour
First Posted:
Nov 15, 2019
Last Update Posted:
Aug 26, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kim Wildgaard, MD,
MD, ph.d.,Clinical Professor,
Herlev Hospital
Additional relevant MeSH terms: