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Mothers' Experience of Category 1 Cesarean Section

Sponsor
Sygehus Lillebaelt (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05840367
Collaborator
University of Southern Denmark, Department of Regional Health Research (Other)
15
Enrollment
19
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Partner present in the operation room

Study Design

Study Type:
Observational
Anticipated Enrollment :
15 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Mothers' Experience of Category 1 Cesarean Section - in a Hospital Where the Partner is Present in the Operating Room. A Qualitative Study.
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Outcome Measures

Primary Outcome Measures

  1. Mothers' experience of the category 1 cesarean section [Three months after the 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.

Secondary Outcome Measures

  1. PTSD [Three months after the cesarean section]

    Occurence of posttraumatic stress as evaluated using the PTSD-8 tool (in Danish)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sygehus Lillebaelt
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Helene Korvenius Nedergaard, MD, PhD, Sygehus Lillebaelt
ClinicalTrials.gov Identifier:
NCT05840367
Other Study ID Numbers:
  • 972294863
First Posted:
May 3, 2023
Last Update Posted:
May 3, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 3, 2023