Viewing Study NCT05840367


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Ignite Modification Date: 2025-12-25 @ 10:57 PM
Study NCT ID: NCT05840367
Status: RECRUITING
Last Update Posted: 2024-04-26
First Post: 2023-04-18
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Mothers' Experience of Category 1 Cesarean Section
Sponsor: Sygehus Lillebaelt
Organization:

Study Overview

Official Title: Mothers' Experience of Category 1 Cesarean Section - in a Hospital Where the Partner is Present in the Operating Room. A Qualitative Study.
Status: RECRUITING
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: