Presence of the Father During Hyperacute Cesarean Section in General Anesthesia

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

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Other: Prescence of the father during cesarean section in general anesthesia

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Denmark
  • Aabenraa, Denmark, 6200
    • Aabenraa Hospital
  • Kolding, Denmark, 6000
    • Helene K. Nedergaard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All mothers and father/partners who experiences a cesarean section category 1 in Kolding Hospital, Denmark.

All mothers and father/partners who experiences a cesarean section category 1 in Aabenraa Hospital, Denmark

Hospital staff (obstetricians, anesthesiologists, pediatricians, midwifes, OR-nurses, anesthetic nurses) in Kolding and Aabenraa hospital, who participate in cesarean sectio category 1.

Description

Inclusion Criteria:

• cesarean section category 1

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obstetric complications	Perforation of bladder or bowel, bleeding > 1000 ml, infection, need for transfusion	Up to 1 week after the cesarean section
Anesthetic complications	Esophageal intubation, difficult airway management	During cesarean section
Neonatal complications	Low APGAR-score, need for resuscitation, need for intubation, need for transfusion	During cesarean section

Collaborators and Investigators

• Sponsor: Sygehus Lillebaelt
• Investigators: Study Chair: Hanne I Jensen, Professor, University Hospital of Southern Denmark, Kolding

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: general anesthesia; cesarean section; hyperacute cesarean section; family presence; experience of family presence
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: SC210815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No