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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Denmark

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 groups in NCT06669156
Study groupRoleWhat they receive
Partuients experiencing conversion of regional to general anesthesia for cesarean sectionAll 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.

  1. 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)
  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.

  1. First posted1 Nov 2024
  2. Study start1 Feb 2025
  3. Primary completion31 Aug 2025
  4. Study completion10 Dec 2025

Resources

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)
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

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.

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