Maternal Hypothermia After Caesarean Section - Implicatio... | NCT07244354

Studies
Maternal Hypothermia After Caesarean Section - Implications for Postoperative Recovery

NCT07244354

Sponsor

Oslo University Hospital

Status

Not yet recruiting

Last Update Posted

Nov 24, 2025Actual

Enrollment

700Estimated

Phase

Not provided

Conditions

Caesarean Section

Interventions

Self report questionnaire

Countries

Norway

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

Nov 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2025Estimated

Primary Completion Date

Nov 1, 2030Estimated

Completion Date

Nov 1, 2030Estimated

First Submitted Date

Nov 17, 2025

First Submission Date that Met QC Criteria

Nov 17, 2025

First Posted Date

Nov 24, 2025Actual

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

Nov 17, 2025

Last Update Posted Date

Nov 24, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elizabeth Reine, Professional development and research nurse, Oslo University HospitalPrincipal Investigator

Lead Sponsor

Oslo University HospitalOTHER

Collaborators

Not provided

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

The aim of the study is to assess patient reported outcomes after caesarean section using self report questionnaire.

Detailed Description

The project consists of two studies: Study 1 explores patient reported outcomes after caesarean section related to recovery and quality of care. Study 2 explores possible associations between perioperative hypothermia during caesarean section and postoperative infection

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

700Estimated

Name	Type	Description	Arm Group Labels	Other Names
Self report questionnaire	Other	No intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient reported recovery after caesarean delivery and symptoms of post caesarean infection	Data collection using questionnaire	Data collection 24 hours after surgery and 7 days after surgery and 30 days after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Caesarean section surgery -

Exclusion Criteria: Stillborn baby, baby admitted to neonatal intensive care,

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Females giving birth through caesarean section

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elizabeth Reine, PhD	Contact	004722119690		uxelkl@ous-hf.no
Irene Brodshaug, MSc	Contact	004722119690

Overall Officials

Name	Affiliation	Role
Elizabeth Reine, PhD	Oslo University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo university hospital		Oslo			Norway

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017060	Patient Satisfaction

Ancestor Terms

ID	Term
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided