Presence of the Father During Hyperacute Cesarean Section in General Anesthesia

NCT04948892 | Completed DMC

• 1 other identifier: SC210815
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 2

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

Keywords

cesarean section; hyperacute cesarean section; family presence; experience of family presence; general anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Mothers experience

  1-2 days after the cesarean section

• Surgeons (obstetricians) experience

  Up to 2 weeks after the cesarean section

• Anesthesiologists experience

  Up to 2 weeks after the cesarean section

• Midwifes experience

  Up to 2 weeks after the cesarean section

• OR nurses experience

  Up to 2 weeks after the cesarean section

Other Outcomes (3)

• Obstetric complications

  Up to 1 week after the cesarean section

• Anesthetic complications

  During cesarean section

• Neonatal complications

  During cesarean section

Study Arms (2)

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

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.

Interventions

Prescence of the father during cesarean section in general anesthesia OTHER

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

Father/partner present, Kolding hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• cesarean section category 1

You may not qualify if:

• none

Sponsors & Collaborators

• Sygehus Lillebaelt: lead

Study Sites (2)

Aabenraa Hospital

Aabenraa, 6200, Denmark

Location

Helene K. Nedergaard

Kolding, 6000, Denmark

Location

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Hanne I Jensen, Professor

  University Hospital of Southern Denmark, Kolding

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 2, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: October 1, 2023
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)