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Completed

NCT Number: NCT04948892

Presence of the Father 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aabenraa Hospital, Aabenraa, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • cesarean section category 1

Exclusion criteria

  • none

Treatment and study plan

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

Primary outcomes

  1. Father/partners experience

    Time frame: 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

    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

Secondary outcomes

  1. Mothers experience

    Time frame: 1-2 days after the cesarean section

    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

  2. Surgeons (obstetricians) experience

    Time frame: Up to 2 weeks after the cesarean section

    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

  3. Anesthesiologists experience

    Time frame: Up to 2 weeks after the cesarean section

    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

  4. Midwifes experience

    Time frame: Up to 2 weeks after the cesarean section

    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

  5. OR nurses experience

    Time frame: Up to 2 weeks after the cesarean section

    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

  6. Anesthetic nurses experience

    Time frame: Up to 2 weeks after the cesarean section

    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

  7. Pediatricians experience

    Time frame: Up to 2 weeks after the cesarean section

    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

Other outcomes

  1. Obstetric complications

    Time frame: Up to 1 week after the cesarean section

    Perforation of bladder or bowel, bleeding > 1000 ml, infection, need for transfusion

  2. Anesthetic complications

    Time frame: During cesarean section

    Esophageal intubation, difficult airway management

  3. Neonatal complications

    Time frame: During cesarean section

    Low APGAR-score, need for resuscitation, need for intubation, need for transfusion

Sponsors and collaborators

Lead sponsor

Sygehus Lillebaelt

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 2, 2021
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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