Presence of the Father During Hyperacute Cesarean Section in General Anesthesia

Cesarean Section Clinical Trial

Official title:

Presence of the Father in the Operating Room During Hyperacute Cesarean Section in General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04948892
• Other study ID #: SC210815
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: April 2024
• Source: Sygehus Lillebaelt
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• cesarean section category 1

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Other:
• 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

Locations

Country	Name	City	State
Denmark	Aabenraa Hospital	Aabenraa
Denmark	Helene K. Nedergaard	Kolding

Sponsors (1)

Lead Sponsor	Collaborator
Sygehus Lillebaelt

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Obstetric complications	Perforation of bladder or bowel, bleeding > 1000 ml, infection, need for transfusion	Up to 1 week after the cesarean section
Other	Anesthetic complications	Esophageal intubation, difficult airway management	During cesarean section
Other	Neonatal complications	Low APGAR-score, need for resuscitation, need for intubation, need for transfusion	During cesarean section
Primary	Father/partners experience	Father/partners experience of being present or not in the OR during the hyperacute cesarean section category 1, described by questionnaire, semi-structured interview and PTSD-screening	1-2 days after the cesarean section combined with assessment of change from baseline in father/partners experience at 3 months after the cesarean sectio
Secondary	Mothers experience	Mothers experience of the father/partner being present or not in the OR during the hyperacute cesarean section category 1, described quantitatively with possibility for qualitative components	1-2 days after the cesarean section
Secondary	Surgeons (obstetricians) experience	Surgeons experience of the father/partner being present or not in the OR during the hyperacute cesarean section category 1, described quantitatively with possibility for qualitative components	Up to 2 weeks after the cesarean section
Secondary	Anesthesiologists experience	Anesthesiologists experience of the father/partner being present or not in the OR during the hyperacute cesarean section category 1, described quantitatively with possibility for qualitative components	Up to 2 weeks after the cesarean section
Secondary	Midwifes experience	Midwifes experience of the father/partner being present or not in the OR during the acute cesarean section category 1, described quantitatively with possibility for qualitative components	Up to 2 weeks after the cesarean section
Secondary	OR nurses experience	OR nurses experience of the father being present or not in the OR during the hyperacute cesarean section category 1, described quantitatively with possibility for qualitative components	Up to 2 weeks after the cesarean section
Secondary	Anesthetic nurses experience	Anesthetic nurses experience of the father/partner being present or not in the OR during the hyperacute cesarean section category 1, described quantitatively with possibility for qualitative components	Up to 2 weeks after the cesarean section
Secondary	Pediatricians experience	Pediatricians experience of the father/partner being present or not in the OR during the hyperacute cesarean section category 1, described quantitatively with possibility for qualitative components	Up to 2 weeks after the cesarean section