Clinical trial NCT04948892: Presence of the Father During Hyperacute Cesarean Section in General Anesthesia
Official title: Presence of the Father in the Operating Room During Hyperacute Cesarean Section in General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section
Keywords: cesarean section
hyperacute cesarean section
family presence
experience of family presence
general anesthesia
Lead sponsor: Sygehus Lillebaelt
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* cesarean section category 1

Exclusion Criteria:

* none

Primary outcomes:
measure: Father/partners experience
timeFrame: 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:
measure: Mothers experience
timeFrame: 1-2 days after the cesarean section
measure: Surgeons (obstetricians) experience
timeFrame: Up to 2 weeks after the cesarean section
measure: Anesthesiologists experience
timeFrame: Up to 2 weeks after the cesarean section
measure: Midwifes experience
timeFrame: Up to 2 weeks after the cesarean section
measure: OR nurses experience
timeFrame: Up to 2 weeks after the cesarean section
measure: Anesthetic nurses experience
timeFrame: Up to 2 weeks after the cesarean section
measure: Pediatricians experience
timeFrame: Up to 2 weeks after the cesarean section
Other outcomes:
measure: Obstetric complications
timeFrame: Up to 1 week after the cesarean section
measure: Anesthetic complications
timeFrame: During cesarean section
measure: Neonatal complications
timeFrame: During cesarean section
Locations:
city: Aabenraa
country: Denmark
facility: Aabenraa Hospital
city: Kolding
country: Denmark
facility: Helene K. Nedergaard
Study officials:
affiliation: University Hospital of Southern Denmark, Kolding
name: Hanne I Jensen, Professor
role: STUDY_CHAIR
References: