Mothers' Experience of Category 1 Cesarean Section

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05840367
• Other study ID #: 972294863
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Sygehus Lillebaelt
• Contact: Helene K Nedergaard, MD, PhD
• Phone: +45 53272244
• Email: helene.korvenius.nedergaard[@]rsyd.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Behavioral:
• Partner present in the operation room
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.

Locations

Country	Name	City	State
Denmark	Lillebaelt Hospital, Kolding	Kolding

Sponsors (2)

Lead Sponsor	Collaborator
Sygehus Lillebaelt	University of Southern Denmark, Department of Regional Health Research

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PTSD	Occurence of posttraumatic stress as evaluated using the PTSD-8 tool (in Danish)	Three months after the cesarean section