Presence of the Father During Hyperacute Cesarean Section in General Anesthesia

NCT ID: NCT04948892

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-10-01

Brief Summary

This study concerns cesarean sections, category 1, meaning those cases where the life of mother and/or fetus is in immedeate danger and the child must be delivered within 15 minutes from activating the cesarean section team. In most hospitals in Denmark, these cesarean sections are most often performed in general anesthesia and the mother is endotracheally intubated.

Previously in these situations, as the mother was rushed from the Labour Ward to the operation room (OR), her spouse/partner, would be placed outside the operating room (OR), and would stay there until the child had been delivered.

In Lillebaelt Hospital, Kolding, Denmark, the newborn-resuscitation table is placed inside the OR. The father would most often be allowed to enter the OR when the child was delivered and placed on the resuscitation table (no matter the status of the child).

However, during spring 2021, Lillebaelt Hospital Kolding updated the policy regarding the handling of the father/partner during cesarean section category 1. Now the father/partner is present in the OR during the whole procedure, including induction of general aesthesia, endotracheal intubation, performance of the cesarean section (drapings are positioned so that the father cannot see the operation field) and potential resuscitation efforts of the newborn.

In another hospital in the same region (Region of Southern Denmark), Aabenraa Hospital, the father is not present in the OR during the cesarean section. He waits in the labour ward.

The investigators therefore wish to investigate how the cesarean section category 1 is experienced by: the father/partner; the mother; the obstetrician; the anestesiologist; the midwife; the OR nurse; the anesthetic nurse, both in Kolding where the father/partner is present in the OR, and in Aabenraa, where the father/partner is not present in the OR during the cesarean sectio.

Conditions

Cesarean Section

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Father/partner present, Kolding hospital

All father/partners, mothers and hospital staff involved in hyperacute cesarean section category 1 in general anesthesia (obstetrician, anesthesiologist, OR-nurse, midwife, anesthetic nurse, pediatrician) in Kolding Hospital, where the father is present in the OR during the cesarean section category 1

Prescence of the father during cesarean section in general anesthesia

Intervention Type: OTHER

The father is now present in the OR during cesarean section category 1, instead of waiting outside

Father/partner not present, Aabenraa hospital

All father/partners and mothers involved in hyperacute cesarean section category 1 in general anesthesia in Aabenraa hospital, where the father is not present in the OR during the cesarean sectio category 1.

All relevant hospital staff, who sometimes participates in cesarean sectio category 1 (obstetrician, anesthesiologist, OR-nurse, midwife, anesthetic nurse, pediatrician) will be asked to fill in a questionnaire on their thoughts and opinions on having the father/partner present during hyperacute cesarean sectio category 1.

No interventions assigned to this group

Interventions

Prescence of the father during cesarean section in general anesthesia

The father is now present in the OR during cesarean section category 1, instead of waiting outside

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• cesarean section category 1

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sygehus Lillebaelt

OTHER

Sponsor Role: lead

Responsible Party

Helene Korvenius Nedergaard

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hanne I Jensen, Professor

Role: STUDY_CHAIR

University Hospital of Southern Denmark, Kolding

Locations

Aabenraa Hospital

Aabenraa, , Denmark

Helene K. Nedergaard

Kolding, , Denmark

Countries

Denmark

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SC210815

Identifier Type: -

Identifier Source: org_study_id