Fever During Labour | NCT04164875

Studies
Fever During Labour

NCT04164875

Sponsor

Herlev Hospital

Status

Unknown status

Last Update Posted

Aug 26, 2021Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Fever; Due to Heat
Infection

Interventions

Temperature measurement

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2021Estimated

Primary Completion Date

Nov 30, 2022Estimated

Completion Date

Aug 30, 2023Estimated

First Submitted Date

Nov 13, 2019

First Submission Date that Met QC Criteria

Nov 13, 2019

First Posted Date

Nov 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2021

Last Update Posted Date

Aug 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Pilot study to assess fever during labour.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Temperature measurement	Diagnostic Test	The 'intervention' is repeated rectal temperature measurements		Fever

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fever	Fever = rectal temp >38 Celsius twice within 60 minutes or 39 degrees Celsius measured once	during labour

Secondary Outcomes

Measure	Description	Time Frame
CRP	infection marker	24 hours
Leucocytosis	infection marker	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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,

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Pregnant women.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kim Wildgaarf, md, phd	Contact	38682170		kim.wildgaard@regionh.dk

Overall Officials

Name	Affiliation	Role
Kim Wildgaard, MD phd	Herlev Hospital, Afdeling for Bedøvelse og Operation	Study Chair
Lærke Vinberg Rasmussen	Herlev Hospital, Dept. of Obstetriscs	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anaesthesiology		Herlev		2730	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005334	Fever
D007239	Infections

Ancestor Terms

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided