Cesarean Delivery Under Neuraxial AnesthesiaNCT07409012
Development of a Patient-Centered Assessment Tool for Pain During Cesarean Delivery
An observational study of Cesarean Delivery Under Neuraxial Anesthesia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study aims to develop an assessment tool to assess intraoperative pain during cesarean delivery under neuroaxial anesthesia. The tool will draw on existing scientific literature, expert clinical opinion and the experiences of patients who have recently undergone caesarean delivery. 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
- Cesarean Delivery Under Neuraxial Anesthesia
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 May 2026to 30 Sep 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: In-Hospital patients which stay at the maternity ward at the University Hospital Basel after cesarean delivery.
Who may be able to join
- Signed informed consent
- Age > 18 years
- Proficient in German or Swiss German
- Category 2-4 Cesarean delivery under neuraxial anesthesia within last 48-72 hours
- Delivery of an healthy infant of at least 35+1 weeks of gestation
Who cannot join
- Known fetal abnormalities or neonatal death
- Admission of the neonate to the ICU
- Severe postpartum hemorrhage of >1000ml blood loss
- Preeclampsia
- Current psychiatric disease, e.g. schizophrenia, personality disorders
- Substance abuse
- Chronic pain disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain During Cesarean Delivery: a Patient-Centered Assessment Tool Developed With Mixed Methods
This study aims to develop an assessment tool to assess intraoperative pain during cesarean delivery under neuroaxial anesthesia. The tool will draw on existing scientific literature, expert clinical opinion and the experiences of patients who have recently undergone caesarean delivery. Experts from multiple disciplines will participate in a structured consensus process (Delphi process) to identify and refine key assessment items. Patient interviews will be conducted to ensure that the tool reflects patient priorities and experiences.
What is being measured
The primary outcome is the main question the study is designed to answer.
The development of an assessment tool with a consensus-based item set for pain during caesarean delivery.
As this is a study focusing on methodological development, the primary outcome is the establishment of a consensus-based, patient-centered assessment tool. This tool is derived from a literature review and finalized through a Delphi process (expert consensus) and patient-centered via cognitive interviews. As the outcome of this study is the finalized set of items, the tool will not be clinically applied to measure the incidence of pain during cesarean delivery within this study. It serves as a foundation for future psychometric validation and research.
Measured: 48-72 hours postoperatively
Secondary outcomes (1)
Identifying themes in qualitative interviews regarding patients' informational priorities before cesarean delivery.
The secondary measure will be assessed in the qualitative interviews with patients after cesarean delivery, during which the items for the assessment tool will be discussed as well. Patients will be asked to share their informational priorities and what they want to know before undergoing a cesarean delivery. To measure this outcome, inductive coding and thematic analysis will be used to identify themes that describe these priorities.
Measured: 48-72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start11 May 2026
- Primary completion30 Jun 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Delivery Under Neuraxial AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409012
- Sponsor's protocol ID
- PDCD
- Status last verified
- Oct 2026
- First submitted
- 19 Jan 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain During Cesarean Delivery: a Patient-Centered Assessment Tool Developed With Mixed Methods
- ClinicalTrials.gov ID
- NCT07409012
- Acronym / sponsor ID
- PDCD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 11 May 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 13 Feb 2026 (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 aims to develop an assessment tool to assess intraoperative pain during cesarean delivery under neuroaxial anesthesia. The tool will draw on existing scientific literature, expert clinical opinion and the experiences of patients who have recently undergone caesarean delivery. Experts from multiple disciplines will participate in a structured consensus process (Delphi process) to identify and refine key assessment items. Patient interviews will be conducted to ensure that the tool reflects patient priorities and experiences.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In-Hospital patients which stay at the maternity ward at the University Hospital Basel after cesarean delivery.
Key inclusion criteria (5 listed)
- Signed informed consent
- Age > 18 years
- Proficient in German or Swiss German
- Category 2-4 Cesarean delivery under neuraxial anesthesia within last 48-72 hours
- Delivery of an healthy infant of at least 35+1 weeks of gestation
Key exclusion criteria (7 listed)
- Known fetal abnormalities or neonatal death
- Admission of the neonate to the ICU
- Severe postpartum hemorrhage of >1000ml blood loss
- Preeclampsia
- Current psychiatric disease, e.g. schizophrenia, personality disorders
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
The development of an assessment tool with a consensus-based item set for pain during caesarean delivery.
Time frame: 48-72 hours postoperatively
As this is a study focusing on methodological development, the primary outcome is the establishment of a consensus-based, patient-centered assessment tool. This tool is derived from a literature review and finalized through a Delphi process (expert consensus) and patient-centered via cognitive interviews. As the outcome of this study is the finalized set of items, the tool will not be clinically applied to measure the incidence of pain during cesarean delivery within this study. It serves as a foundation for future psychometric validation and research.
1 secondary outcome
Identifying themes in qualitative interviews regarding patients' informational priorities before cesarean delivery.
Time frame: 48-72 hours postoperatively
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 27 Oct 2026.
- 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.
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 Cesarean Delivery Under Neuraxial Anesthesia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 5 inclusion and 7 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 27 Oct 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 Switzerland. 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?
The development of an assessment tool with a consensus-based item set for pain during caesarean delivery. (time frame: 48-72 hours postoperatively). 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 27 Oct 2026.