Cesarean SectionNCT04948892
Presence of the Father During Hyperacute Cesarean Section in General Anesthesia
An observational study of Cesarean Section, run by Sygehus Lillebaelt at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Prescence of the father during cesarean section in general anesthesia
- How many people
- 26 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Jan 2022to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- cesarean section category 1
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aabenraa Hospital
Aabenraa, 6200
Helene K. Nedergaard
Kolding, 6000
About this study
Official title: 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.
Read more
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
- Being tested
- Prescence of the father during cesarean section in general anesthesia
- Keywords
- cesarean section, hyperacute cesarean section, family presence, experience of family presence, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescence of the father during cesarean section in general anesthesiaOther
The father is now present in the OR during cesarean section category 1, instead of waiting outside
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 2 weeks after the cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sygehus Lillebaelt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helene Korvenius Nedergaard, Sygehus Lillebaelt
- Investigators
- Hanne I Jensen, Professor, Study chair, University Hospital of Southern Denmark, Kolding
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948892
- Sponsor's protocol ID
- SC210815
- Status last verified
- Apr 2024
- First submitted
- 24 Jun 2021
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nedergaard HK, Weitling EE, Rahbech M, Froslev-Friis C, Quitzau LH, Strom T, Brochner AC, Jensen HI. Presence of the partner in the operating room during a category 1 cesarean section: a prospective explorative study. Int J Obstet Anesth. 2024 Feb;57:103939. doi: 10.1016/j.ijoa.2023.103939. Epub 2023 Oct 10.
PubMed 37891124
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence of the Father in the Operating Room During Hyperacute Cesarean Section in General Anesthesia
- ClinicalTrials.gov ID
- NCT04948892
- Acronym / sponsor ID
- SC210815
- Conditions
- Cesarean Section
- Keywords
- cesarean section, hyperacute cesarean section, family presence, experience of family presence, general anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sygehus LillebaeltUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Father/partner present, Kolding hospital | – | Other: Prescence of the father during cesarean section in general anesthesiaAll 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- cesarean section category 1
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prescence of the father during cesarean section in general anesthesiaThe father is now present in the OR during cesarean section category 1, instead of waiting outside | Other | Father/partner present, Kolding hospital |
Primary outcome
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
7 secondary outcomes
Mothers experience
Time frame: 1-2 days after the cesarean section
Surgeons (obstetricians) experience
Time frame: Up to 2 weeks after the cesarean section
Anesthesiologists experience
Time frame: Up to 2 weeks after the cesarean section
Midwifes experience
Time frame: Up to 2 weeks after the cesarean section
OR nurses experience
Time frame: Up to 2 weeks after the cesarean section
Anesthetic nurses experience
Time frame: Up to 2 weeks after the cesarean section
Pediatricians experience
Time frame: Up to 2 weeks after the cesarean section
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Derived from this study: PubMed 37891124Nedergaard HK, Weitling EE, Rahbech M, Froslev-Friis C, Quitzau LH, Strom T, Brochner AC, Jensen HI. Presence of the partner in the operating room during a category 1 cesarean section: a prospective explorative study. Int J Obstet Anesth. 2024 Feb;57:103939. doi: 10.1016/j.ijoa.2023.103939. Epub 2023 Oct 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanne I Jensen, Professor study chair
University Hospital of Southern Denmark, Kolding
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section, run by Sygehus Lillebaelt at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04948892, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.