Maternal Hypothermia After Caesarean Section - Implications for Postoperative Recovery

November 17, 2025 updated by: Elizabeth Reine, Oslo University Hospital
The aim of the study is to assess patient reported outcomes after caesarean section using self report questionnaire.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

700

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 Contact Backup

  • Name: Irene Brodshaug, MSc
  • Phone Number: 004722119690

Study Locations

  • Norway
      • Oslo, Norway
        • Oslo University Hospital
        • Contact:
        • Contact:
          • Reine

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

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Females giving birth through caesarean section

Description

Inclusion Criteria: Caesarean section surgery -

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

-

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

Collaborators and Investigators

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

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Elizabeth Reine, PhD, Oslo University Hospital

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 (Estimated)

December 1, 2025

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

November 1, 2030

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 911621

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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