Cesarean Section ComplicationsNCT06669156
Insufficient Regional Anesthesia and Conversion to General Anesthesia for Cesarean Section A Qualitative Multicenter Study
An observational study of Cesarean Section Complications and Cesarean Section Pain, run by Sygehus Lillebaelt at 7 sites in Denmark.
Trial summary
Background In Denmark, approximately 20% of all children are born via cesarean section (C-section), making it the most common surgical procedure (also internationally). The recommended anesthesia for cesarean sections is regional anesthesia (spinal or epidural, "spinal anesthesia"), as it has several advantages: the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section Complications, Cesarean Section Pain, Regional Anesthesia
- How many people
- 21 participants
- Where
- 7 sitesDenmark
- Study dates
- 1 Feb 2025to 10 Dec 2025
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The project encompasses all women at the participating centers who experience insufficient regional anesthesia during a cesarean section and conversion to general anesthesia. Based on experience, this occurs relatively infrequently, but is estimated to happen 5-10 times a year at each participating center. It is anticipated that some women may decline to participate in the project, and since cesarean sections occur at all times of the day and year, the project group may risk not identifying some cases. The number of women required to participate before a sufficient amount of information is obtained (as no new information is expected from subsequent interviews) is not known in advance; however, it is estimated that 20-30 women will need to participate. Therefore, the inclusion period is expected to last for one year.
Who may be able to join
- Women undergoing elective or emergency cesarean section, aged over 17 years
- Regional (spinal or epidural or combined epidural-spinal) anesthesia converted to general anesthesia intraoperatively (i.e., after surgery has commenced) due to insufficient regional anesthesia (i.e., not for obstetric indications, such as in cases of difficult fetal extraction)
Who cannot join
- Does not speak Danish or English
- Does not wish to participate
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Denmark7 sites
Aalborg Hospital
Aalborg, 9000
Rigshospitalet, Copenhagen University Hospital
Copenhagen
Herlev Hospital
Herlev
Hillerød Hospital
Hillerød, 3400
Lillebaelt Hospital, Kolding
Kolding, 6000
Roskilde Hospital
Roskilde, 4000
Viborg Hospital
Viborg, Region Midt
About this study
Background In Denmark, approximately 20% of all children are born via cesarean section (C-section), making it the most common surgical procedure (also internationally). The recommended anesthesia for cesarean sections is regional anesthesia (spinal or epidural, "spinal anesthesia"), as it has several advantages: the woman is awake and experiences the delivery of her child, she maintains spontaneous breathing (the risk of difficult airway management is significantly higher in pregnant women), and the risk of aspiration of stomach contents into the lungs (which is clearly increased in pregnant women) is reduced. Furthermore, regional anesthesia can contribute to early postoperative pain management to some extent.
With spinal anesthesia, most women feel pressure and touch but no pain during the cesarean section. However, some women do experience pain during the procedure, necessitating a change in the plan. If inadequate anesthesia is detected before the surgery begins, one may choose (depending on, for example, the urgency of the cesarean) to administer renewed regional anesthesia (typically an epidural). However, if the woman first experiences pain after the surgery has commenced, it is necessary to place her under general anesthesia for the remainder of the procedure. Experience shows that this process can be challenging, and there are frequent examples in clinical practice of inappropriate courses of action, where women have experienced unacceptable pain during their cesarean sections without being placed under general anesthesia. It is difficult to obtain an exact figure on how many women experience inadequate anesthesia during cesarean sections under regional anesthesia, as not all cases are recognized or followed up on. Studies indicate that up to 12% experience pain during a cesarean section.
Read more
The consequences of inadequate anesthesia for cesarean sections can be quite significant for women, including impaired bonding with the child, poorer establishment of breastfeeding, increased risk of postpartum reactions and post-traumatic stress, as well as (anecdotally) the risk of women opting out of future pregnancies, as they may be reluctant to subject themselves to a similar situation again.
Aim The aim of this study is to investigate how women experience insufficient regional anesthesia during cesarean sections that require conversion to general anesthesia. The focus is on exploring the factors that contribute positively and negatively to the woman's experience in this situation.
Method Qualitative study in six Danish hospitals.
Inclusion criteria:
- Women undergoing elective or emergency cesarean section, aged over 17 years
- Regional (spinal or epidural or combined epidural-spinal) anesthesia converted to general anesthesia intraoperatively (i.e., after surgery has commenced) due to insufficient regional anesthesia (i.e., not for obstetric indications, such as in cases of difficult fetal extraction)
Exclusion criteria:
- Does not speak Danish or English
- Does not wish to participate
The woman will be contacted for the first time on day 1 or 2 after the cesarean section (before she is discharged from the hospital). She will be informed about the project and invited to participate. As a potential project participant, she is entitled to a 24-hour consideration period, and if desired, a new contact will be arranged for the following day. If she wishes to participate, she will be contacted again after 3 months. At this time, she will receive a call to schedule a follow-up telephone interview within a few days. This will take place as a semi-structured interview, initiated with open questions and concluded with a few more specific questions. At the end of the interview, a screening for post-traumatic stress will be conducted using the PTSD-8 tool. Follow-up interviews will be recorded digitally and transcribed verbatim.
Sample Size The project encompasses all women at the participating centers who experience insufficient regional anesthesia during a cesarean section and conversion to general anesthesia during 1 year.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Partuients experiencing conversion of regional to general anesthesia for cesarean section | All parturients undergoing emergency or elective cesarean section in a participating hospital, who experience insufficient regional anesthesia and conversion to general anesthesia during the 1 year inclusion period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parturients experience of insufficient regional anesthesia and conversion to general anesthesia
Parturients experience of insufficient regional anesthesia during cesarean sections that require conversion to general anesthesia.
Investigated through semi-structured telephone interviews.
The focus is on exploring the factors that contribute positively and negatively to the woman's experience of this situation.
Measured: Three months after the cesarean section
Secondary outcomes (1)
Posttraumatic stress
Parturients will be screened for symptoms of posttraumatic stress, using the PTSD-8 screening tool, at the end of the follow-up telephone-interview.
Measured: Three months 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 posted1 Nov 2024
- Study start1 Feb 2025
- Primary completion31 Aug 2025
- Study completion10 Dec 2025
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 Section ComplicationsStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sygehus Lillebaelt
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of North Zealand, Copenhagen University Hospital at Herlev, Aalborg University Hospital, Copenhagen University Hospital, Denmark, Zealand University Hospital
- Responsible party
- Principal investigator, Helene Korvenius Nedergaard, Sygehus Lillebaelt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669156
- Sponsor's protocol ID
- 24/67884
- Status last verified
- Aug 2026
- First submitted
- 31 Oct 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nedergaard HK, Duch P, Wikkelso AJ, Abildgren ML, Lund-Olesen J, Wildgaard K, Ekelund K. Women's reported experience of conversion to general anesthesia for cesarean delivery with inadequate neuraxial anesthesia: a qualitative prospective multicenter Danish study. Int J Obstet Anesth. 2026 May;66:104882. doi: 10.1016/j.ijoa.2026.104882. Epub 2026 Feb 21.
PubMed 41747363
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insufficient Regional Anesthesia and Conversion to General Anesthesia for Cesarean Section A Qualitative Multicenter Study
- ClinicalTrials.gov ID
- NCT06669156
- Acronym / sponsor ID
- 24/67884
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sygehus LillebaeltUniversity, hospital or other
- Collaborators
- University Hospital of North Zealand, Copenhagen University Hospital at Herlev, Aalborg University Hospital, Copenhagen University Hospital, Denmark, Zealand University Hospital
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 1 Nov 2024 (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.
Background In Denmark, approximately 20% of all children are born via cesarean section (C-section), making it the most common surgical procedure (also internationally). The recommended anesthesia for cesarean sections is regional anesthesia (spinal or epidural, "spinal anesthesia"), as it has several advantages: the woman is awake and experiences the delivery of her child, she maintains spontaneous breathing (the risk of difficult airway management is significantly higher in pregnant women), and the risk of aspiration of stomach contents into the lungs (which is clearly increased in pregnant women) is reduced. Furthermore, regional anesthesia can contribute to early postoperative pain management to some extent.
With spinal anesthesia, most women feel pressure and touch but no pain during the cesarean section. However, some women do experience pain during the procedure, necessitating a change in the plan. If inadequate anesthesia is detected before the surgery begins, one may choose (depending on, for example, the urgency of the cesarean) to administer renewed regional anesthesia (typically an epidural). However, if the woman first experiences pain after the surgery has commenced, it is necessary to place her under general anesthesia for the remainder of the procedure. Experience shows that this process can be challenging, and there are frequent examples in clinical practice of inappropriate courses of action, where women have experienced unacceptable pain during their cesarean sections without being placed under general anesthesia. It is difficult to obtain an exact figure on how many women experience inadequate anesthesia during cesarean sections under regional anesthesia, as not all cases are recognized or followed up on. Studies indicate that up to 12% experience pain during a cesarean section.
The consequences of inadequate anesthesia for cesarean sections can be quite significant for women, including impaired bonding with the child, poorer establishment of breastfeeding, increased risk of postpartum reactions and post-traumatic stress, as well as (anecdotally) the risk of women opting out of future pregnancies, as they may be reluctant to subject themselves to a similar situation again.
Aim The aim of this study is to investigate how women experience insufficient regional anesthesia during cesarean sections that require conversion to general anesthesia. The focus is on exploring the factors that contribute positively and negatively to the woman's experience in this situation.
Method Qualitative study in six Danish hospitals.
Inclusion criteria:
- Women undergoing elective or emergency cesarean section, aged over 17 years
- Regional (spinal or epidural or combined epidural-spinal) anesthesia converted to general anesthesia intraoperatively (i.e., after surgery has commenced) due to insufficient regional anesthesia (i.e., not for obstetric indications, such as in cases of difficult fetal extraction)
Exclusion criteria:
- Does not speak Danish or English
- Does not wish to participate
The woman will be contacted for the first time on day 1 or 2 after the cesarean section (before she is discharged from the hospital). She will be informed about the project and invited to participate. As a potential project participant, she is entitled to a 24-hour consideration period, and if desired, a new contact will be arranged for the following day. If she wishes to participate, she will be contacted again after 3 months. At this time, she will receive a call to schedule a follow-up telephone interview within a few days. This will take place as a semi-structured interview, initiated with open questions and concluded with a few more specific questions. At the end of the interview, a screening for post-traumatic stress will be conducted using the PTSD-8 tool. Follow-up interviews will be recorded digitally and transcribed verbatim.
Sample Size The project encompasses all women at the participating centers who experience insufficient regional anesthesia during a cesarean section and conversion to general anesthesia during 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Partuients experiencing conversion of regional to general anesthesia for cesarean section | – | –All parturients undergoing emergency or elective cesarean section in a participating hospital, who experience insufficient regional anesthesia and conversion to general anesthesia during the 1 year inclusion period |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The project encompasses all women at the participating centers who experience insufficient regional anesthesia during a cesarean section and conversion to general anesthesia. Based on experience, this occurs relatively infrequently, but is estimated to happen 5-10 times a year at each participating center. It is anticipated that some women may decline to participate in the project, and since cesarean sections occur at all times of the day and year, the project group may risk not identifying some cases. The number of women required to participate before a sufficient amount of information is obtained (as no new information is expected from subsequent interviews) is not known in advance; however, it is estimated that 20-30 women will need to participate. Therefore, the inclusion period is expected to last for one year.
Key inclusion criteria (2 listed)
- Women undergoing elective or emergency cesarean section, aged over 17 years
- Regional (spinal or epidural or combined epidural-spinal) anesthesia converted to general anesthesia intraoperatively (i.e., after surgery has commenced) due to insufficient regional anesthesia (i.e., not for obstetric indications, such as in cases of difficult fetal extraction)
Key exclusion criteria (2 listed)
- Does not speak Danish or English
- Does not wish to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Parturients experience of insufficient regional anesthesia and conversion to general anesthesia
Time frame: Three months after the cesarean section
Parturients experience of insufficient regional anesthesia during cesarean sections that require conversion to general anesthesia. Investigated through semi-structured telephone interviews. The focus is on exploring the factors that contribute positively and negatively to the woman's experience of this situation.
1 secondary outcome
Posttraumatic stress
Time frame: Three months 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 14 Aug 2026.
- Derived from this study: PubMed 41747363Nedergaard HK, Duch P, Wikkelso AJ, Abildgren ML, Lund-Olesen J, Wildgaard K, Ekelund K. Women's reported experience of conversion to general anesthesia for cesarean delivery with inadequate neuraxial anesthesia: a qualitative prospective multicenter Danish study. Int J Obstet Anesth. 2026 May;66:104882. doi: 10.1016/j.ijoa.2026.104882. Epub 2026 Feb 21.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
The record lists no contact. Use the official record to reach the sponsor.
7 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 Complications and Cesarean Section Pain, run by Sygehus Lillebaelt at 7 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 2 inclusion and 2 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 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Parturients experience of insufficient regional anesthesia and conversion to general anesthesia (time frame: Three months after the cesarean section). 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 NCT06669156, 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 14 Aug 2026.