Caesarean SectionNCT07134179
Insufficient Regional Anesthesia for Cesarean Section: Mothers' Experiences A Qualitative Study
An observational study of Caesarean Section and Regional Anesthesia, run by Sygehus Lillebaelt at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Caesarean Section, Regional Anesthesia
- What is being tested?
- Experience of pain during caesarean delivery
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Aug 2025to 1 Apr 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women, who have undergone elective or emergency caesarean delivery within the past 2 years under regnional anesthesia and experienced pain during the operation without conversion to general anesthesia will be invited to participate, either via posts on social media or when met in clinical work.
Who may be able to join
- Women undergoing elective or emergency cesarean delivery within the last 2 years, with the experience of pain during surgery
- Regional (spinal or epidural or combined epidural-spinal) anesthesia NOT converted to general anesthesia
- Age ≥18 years
Who cannot join
- Does not speak Danish or English
- Does not wish to participate
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University Hospital of Southern Denmark, Lillebaelt Hospital Kolding
Kolding, Region Syddanmark, 6000
About this study
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. 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 further intervention or ultimately a change in anesthetic form. If inadequate anesthesia is detected before the surgery begins, one may choose to administer renewed regional anesthesia (typically an epidural). However, if the woman first experiences pain after the surgery has commenced, it can be 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.
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.
The aim of this study is to investigate how women experience insufficient regional anesthesia during cesarean sections, in cases where the regional anesthesia was not converted to general anesthesia. The focus is on exploring the factors that contribute positively and negatively to the woman's experience in this situation, and investigate if any recommendations for how to handle the situation can be extrapolated from the women's experiences.
Method Qualitative study.
Inclusion criteria:
- Adult women undergoing elective or emergency cesarean delivery within the last 2 years, with the experience of pain during surgery
- Regional (spinal or epidural or combined epidural-spinal) anesthesia NOT converted to general anesthesia
Exclusion criteria:
- Does not speak Danish or English
- Does not wish to participate
Relevant women will be invited to contact us through public post on social media. If a woman responds to the post, she will be offered further information about the project, both verbally via telephone and in writing sent by email.
Women can also be invited to participate if encountered by a project-group member during clinical work.
Participants will be invited to an interview via telephone. 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.
Interviews will be recorded digitally and transcribed verbatim. The interview guide will be developed with input from the entire project group and with participation from three mothers who have previously experienced insufficient regional anesthesia during a cesarean section. The guide will be pilot-tested on 2-3 patients after cesarean section. The interview guide may be adjusted during the study, if necessary.
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 women will need to participate. However, the sample size is also defined by convenience, as the investigators do not know how many women it will be possible to establish contact with via the Facebook post and through clinical work. If too few women (e.g. <15) are included within the first two months, the investigators will make a new public posting and expand the period of inclusion to concern cesarean sections within the last 5 years instead of 2 years.
Baseline data regarding the mother and the cesarean section will be collected by asking the women during the scheduled interview, and therefore access to medical records are not necessary. Qualitative data will also be gathered through the interview, conducted as a semi-structured interview based on an interview guide.
Data will be entered into SurveyXact software, where it will be securely stored. Data will be handled using descriptive statistics. Interview data will be analyzed using content analysis. Nvivo software will be used for managing and coding qualitative data.
- Conditions
- Caesarean Section, Regional Anesthesia
- Being tested
- Experience of pain during caesarean delivery
- Keywords
- pain during caesarean section, insufficient regional anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experience of pain during caesarean deliveryOther
We wish to investigate how women experience insufficient regional anesthesia during cesarean sections, in cases where the regional anesthesia was not converted to general anesthesia. The focus is on exploring the factors that contribute positively and negatively to the woman's experience in this situation
| Study group | Role | What they receive |
|---|---|---|
| Women, who experienced pain during caesarean delivery | Adult women, who underwent elective or emergency cesarean delivery within the last 2 years, with the experience of pain during surgery, under regional (spinal or epidural or combined epidural-spinal) anesthesia, that was not converted to general anesthesia Receives: Other: Experience of pain during caesarean delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience of pain during caesarean section
The primary outcome is the women's experience of pain during caesarean delivery. This will be assessed through the qualitative method "manifest content analysis". All participating women will be interviewed using a semi-structured model based on an interview guide. All interviews will be transscribed verbatim and analysed by three to four researchers to identify relevant themes, describing the women's experience.
Measured: Experience of caesarean delivery, max 2 years ago
Secondary outcomes (1)
Posttraumatic stress
Screening for posttraumatic stress, using the PTSD-8 inventory (in Danish), verbally during the telephone interview. The PTSD-8 inventory consists of 8 questions regarding the event (in this case the cesarean section). Each question can be answered with "not at all, rarely, sometimes of often", which corresponds to 1, 2, 3 and 4 points, respectively. Total score will be between 0 and 32. Higher scores indicates higher likelyhood of posttraumatic stress.
Measured: Posttraumatic stress related to caesarean delivery max 2 years ago
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start15 Aug 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sygehus Lillebaelt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helene Korvenius Nedergaard, Sygehus Lillebaelt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134179
- Sponsor's protocol ID
- REC607
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD in this study will be confidential interviews.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insufficient Regional Anesthesia for Cesarean Section: Mothers' Experiences A Qualitative Study
- ClinicalTrials.gov ID
- NCT07134179
- Acronym / sponsor ID
- REC607
- Conditions
- Caesarean Section, Regional Anesthesia
- Keywords
- pain during caesarean section, insufficient regional anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sygehus LillebaeltUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 21 Aug 2025 (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.
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. 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 further intervention or ultimately a change in anesthetic form. If inadequate anesthesia is detected before the surgery begins, one may choose to administer renewed regional anesthesia (typically an epidural). However, if the woman first experiences pain after the surgery has commenced, it can be 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.
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.
The aim of this study is to investigate how women experience insufficient regional anesthesia during cesarean sections, in cases where the regional anesthesia was not converted to general anesthesia. The focus is on exploring the factors that contribute positively and negatively to the woman's experience in this situation, and investigate if any recommendations for how to handle the situation can be extrapolated from the women's experiences.
Method Qualitative study.
Inclusion criteria:
- Adult women undergoing elective or emergency cesarean delivery within the last 2 years, with the experience of pain during surgery
- Regional (spinal or epidural or combined epidural-spinal) anesthesia NOT converted to general anesthesia
Exclusion criteria:
- Does not speak Danish or English
- Does not wish to participate
Relevant women will be invited to contact us through public post on social media. If a woman responds to the post, she will be offered further information about the project, both verbally via telephone and in writing sent by email.
Women can also be invited to participate if encountered by a project-group member during clinical work.
Participants will be invited to an interview via telephone. 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.
Interviews will be recorded digitally and transcribed verbatim. The interview guide will be developed with input from the entire project group and with participation from three mothers who have previously experienced insufficient regional anesthesia during a cesarean section. The guide will be pilot-tested on 2-3 patients after cesarean section. The interview guide may be adjusted during the study, if necessary.
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 women will need to participate. However, the sample size is also defined by convenience, as the investigators do not know how many women it will be possible to establish contact with via the Facebook post and through clinical work. If too few women (e.g. <15) are included within the first two months, the investigators will make a new public posting and expand the period of inclusion to concern cesarean sections within the last 5 years instead of 2 years.
Baseline data regarding the mother and the cesarean section will be collected by asking the women during the scheduled interview, and therefore access to medical records are not necessary. Qualitative data will also be gathered through the interview, conducted as a semi-structured interview based on an interview guide.
Data will be entered into SurveyXact software, where it will be securely stored. Data will be handled using descriptive statistics. Interview data will be analyzed using content analysis. Nvivo software will be used for managing and coding qualitative data.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women, who experienced pain during caesarean delivery | – | Other: Experience of pain during caesarean deliveryAdult women, who underwent elective or emergency cesarean delivery within the last 2 years, with the experience of pain during surgery, under regional (spinal or epidural or combined epidural-spinal) anesthesia, that was not converted to general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women, who have undergone elective or emergency caesarean delivery within the past 2 years under regnional anesthesia and experienced pain during the operation without conversion to general anesthesia will be invited to participate, either via posts on social media or when met in clinical work.
Key inclusion criteria (3 listed)
- Women undergoing elective or emergency cesarean delivery within the last 2 years, with the experience of pain during surgery
- Regional (spinal or epidural or combined epidural-spinal) anesthesia NOT converted to general anesthesia
- Age ≥18 years
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experience of pain during caesarean deliveryWe wish to investigate how women experience insufficient regional anesthesia during cesarean sections, in cases where the regional anesthesia was not converted to general anesthesia. The focus is on exploring the factors that contribute positively and negatively to the woman's experience in this situation | Other | Women, who experienced pain during caesarean delivery |
Primary outcome
Experience of pain during caesarean section
Time frame: Experience of caesarean delivery, max 2 years ago
The primary outcome is the women's experience of pain during caesarean delivery. This will be assessed through the qualitative method "manifest content analysis". All participating women will be interviewed using a semi-structured model based on an interview guide. All interviews will be transscribed verbatim and analysed by three to four researchers to identify relevant themes, describing the women's experience.
1 secondary outcome
Posttraumatic stress
Time frame: Posttraumatic stress related to caesarean delivery max 2 years ago
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 17 Aug 2026.
- Individual participant dataSharing planned: No. IPD in this study will be confidential interviews.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caesarean Section and Regional Anesthesia, run by Sygehus Lillebaelt at 1 site 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 3 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 17 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 1 site 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?
Experience of pain during caesarean section (time frame: Experience of caesarean delivery, max 2 years ago). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2026.