Mothers' Experience of Category 1 Cesarean Section

NCT05840367 | Recruiting

• 1 other identifier: 972294863
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• PTSD

  Three months after the cesarean section

Interventions

Partner present in the operation room BEHAVIORAL

The partner (father, co-mother or other close relative present for the birth) is present in the operation room during the entire category 1 cesarean section. This is standard clinical practice in this particular hospital since June 2021.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Not speaking/understanding Danish

Sponsors & Collaborators

• Sygehus Lillebaelt: lead
• University of Southern Denmark, Department of Regional Health Research: collaborator

Study Sites (1)

Lillebaelt Hospital, Kolding

Kolding, 6000, Denmark

RECRUITING

Study Officials

• 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 CHAIR

Central Study Contacts

Helene K Nedergaard, MD, PhD

CONTACT

+45 53272244; helene.korvenius.nedergaard@rsyd.dk

Eva Weitling, MD

CONTACT

eva.weitling@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 3, 2023
• Study Start: June 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)