Mothers' Experience of Category 1 Cesarean Section

Mothers' Experience of Category 1 Cesarean Section - in a Hospital Where the Partner is Present in the Operating Room. A Qualitative Study.

The aim of this qualitative prospective study is to investigate how mothers experience a category 1 cesarean section in a hospital where the partner is present in the operation room during the entire process (induction of general anestesia, cesarean section, possible resuscitation of newborn).

Mothers will be included in the study, if they wish to participate, on day 1 or 2 following the cesarean section and a brief, structured interview will be held concerning her experience of the cesarean section.

Clinical baseline data regarding the mother, the cesarean section and the infant will be collected from patients files.

Mothers will be contacted again three months after the cesarean section, and a semi-structured interview will be held via telephone. At the end of the interview a screening for posttraumatic stress will be performed, using the PTSD-8 tool. The interviews will be recorded and transscribed verbatim.

Content of interviews will be analysed using manifest content analysis. NVivo software will be used for coding interviews.

Study Overview

• Status: Recruiting
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Behavioral: Partner present in the operation room

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: Helene K Nedergaard, MD, PhD; Phone Number: +45 53272244; Email: helene.korvenius.nedergaard@rsyd.dk
• Study Contact Backup: Name: Eva Weitling, MD; Email: eva.weitling@rsyd.dk

Study Locations

• Denmark
  • Kolding, Denmark, 6000
    • Recruiting
    • Lillebaelt Hospital, Kolding
    • Contact: Helene K Nedergaard, MD, PhD; Phone Number: +45 53272244; Email: helene.korvenius.nedergaard@rsyd.dk
    • Contact: Eva E Weitling, MD; Email: eva.weitling@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study aims to include all mothers who undergoes a category 1 cesarean section in Kolding Hospital, Denmark, during a 1-year period. Mothers will be approached for inclusion in the study regardless of the outcome of the infant.

Description

Inclusion Criteria:

• Mothers who had a category 1 cesarean section in Kolding Hospital, Denmark during a 1-year period

Exclusion Criteria:

• Not speaking/understanding Danish

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mothers' experience of the category 1 cesarean section	Qualitative analysis of data regarding mothers' experience of a category 1 cesarean section in a hospital where the partner is present in the operation room. Semi-structured interviews will be held, recorded digitally and transscribed. Content will be analysed qualitatively using manifest content analysis, and major themes as well as sub-themes will be identified, describing mothers' experience with the category 1 cesarean section.	Three months after the cesarean section

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD	Occurence of posttraumatic stress as evaluated using the PTSD-8 tool (in Danish)	Three months after the cesarean section

Collaborators and Investigators

• Sponsor: Sygehus Lillebaelt
• Collaborators: University of Southern Denmark, Department of Regional Health Research
• Investigators: Study Chair: Anne C Brøchner, MD, Associate Professor, Lillebaelt Hospital Kolding, Department of Anesthesiology and Intensive Care, and University of Southern Denmark, Department of Regional Health Research

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 972294863

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No