Cesarean Section ComplicationsNCT06247852
Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
An observational study of Cesarean Section Complications and Cesarean Section, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
In Denmark, around 12,700 patients undergo Cesarean delivery (CD) annually, constituting approximately 20% of all childbirths in the country. Worldwide, the number is increasing each year, with more than 20 million CD performed annually. 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, Cesarean Delivery
- How many people
- 477 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2023to 1 Sep 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
- Adult, Older adult
Study population: Patients, aged > 18 years, who undergo planned cesarean delivery under spinal anesthesia.
Who may be able to join
- Patients who, after participating in the Danish multicenter cohort study on pain after cesarean delivery (ClinicalTrials.gov Identifier: NCT06012747), consent to continue to receive questionnaires about persistent pain.
- Planned cesarean delivery in spinal anesthesia
- Patients who speak and read Danish
- Patients with a smartphone that can receive an SMS with a link to a questionnaire that can be opened online.
Who cannot join
- <18 years of age
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anesthesiology, Copenhagen University Hospital, North Zealand Hillerød
Hillerød, 3400
About this study
In Denmark, around 12,700 patients undergo Cesarean delivery (CD) annually, constituting approximately 20% of all childbirths in the country. Worldwide, the number is increasing each year, with more than 20 million CD performed annually.
Postoperative pain after CD is typically moderate to severe in intensity and still constitutes a significant challenge, balancing effective pain relief and potential side effects. Correlations between moderate to severe acute pain and the development of persistent pain after CD is still unclear.
Read more
Postsurgical persistent pain is a significant, often unrecognized clinical problem that causes distress and diminishes the quality of life for patients. Despite advances in understanding the factors contributing to persistent postsurgical pain and an increased focus on identifying patients at risk, the management and prevention of postsurgical persistent pain are still inadequate.
It is important to gain further insights into this population, and we have a unique opportunity to do so by following the national cohort from the ongoing Danish multicenter cohort study on pain after cesarean section (ClinicalTrials.gov Identifier: NCT06012747) over an extended follow-up period.
This involves continued prospective registration of Patient-Reported Outcome Measures (PROM) collected by SMS-based questionnaires in the months and years after the CD, thereby investigating the occurrence of both acute and persistent pain after CD.
The outcomes are focused on pain levels, the impact of pain on physical function and neuropathic pain characteristics in the months and years following the CD. The study also aims to explore the relationship between persistent and acute pain.
Read the detailed description
The Study Protocol is attached in full-text (Study Documents).
- Conditions
- Cesarean Section Complications, Cesarean Section, Cesarean Delivery, Persistent Pain, Chronic Pain, SMS
- Keywords
- persistent pain, chronic pain, Danish cohort, cesarean section, cesarean delivery, acute on chronic pain, post operative pain, SMS questionnaire
- Medical subject headings
- Chronic Pain, Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent pain
The percentage of patients reporting pain equivalent to an NRS score > 3 after 6 months
Measured: after 6 months
Secondary outcomes (23)
Severe pain during the last 24 hours.
NRS 0-10
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Severe pain at rest during the last 24 hours.
NRS 0-10
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Use of analgesic medication in the past week due to pain (Paracetamol, Non-Steroidal Anti-Inflammatory Drug, opioid).
Yes/No
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain's affect on daily activities
1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain's affect on engaging in strenuous physical activity.
1-6: Not at all, a little, to some extent, to a great extent, cannot do due to pain, I don't know - I haven't tried.
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain's affect on meeting the infant's needs.
1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain's affect on sleep.
1-4: Not at all, a little, to some extent, to a great extent.
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain's affect on mood.
1-4: Not at all, a little, to some extent, to a great extent.
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain/discomfort when sitting down or standing up from a chair.
1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain/discomfort when walking on stairs.
1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain/discomfort when getting in or out of bed.
1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain/discomfort when carrying the infant.
1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain/discomfort when sitting up for less than 30 minutes.
1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain/discomfort if sitting up for more than 30 minutes.
1-6: Not at all, a little, to some extent, to a great extent, cannot do due to pain, I don't know - I haven't tried.
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain/discomfort when moving around at home.
1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain/discomfort if walking for more than 30 minutes.
1-6: Not at all, a little, to some extent, to a great extent, cannot do due to pain, I don't know - I haven't tried.
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain/discomfort when bending down.
1-5: Not at all, a little, to some extent, to a great extent, cannot do due to pain.
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain/discomfort during or after sexual intercourse.
1-7: Not at all, a little, to some extent, to a great extent, cannot do due to pain, I don't know - I haven't tried, I prefer not to answer.
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pins and needles, tingling or stabbing sensations in or around the area of the surgery?
Yes/No
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Electric shock like sensation or jabbing feelings in the skin area in or around the area of the surgery?
Yes/No
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Heat or burning sensations in or around the area of the surgery?
Yes/No
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain caused by the lightest of touches in or around the area of the surgery?
Yes/No
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain caused by cold temperatures in or around the area of surgery?
Yes/No
Measured: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Sep 2023
- Primary completion10 Jun 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Duch, Nordsjaellands Hospital
- Investigators
- Patricia Duch, MD, Principal investigator, University Hospital of Copenhagen, Hillerød, DenmarkHelene Nedergaard, MD, Ph.D, Study director, University Hospital of Southern Denmark, KoldingChristoffer Jørgensen, Dr. Med., Study director, University Hospital of Copenhagen, Hillerød, DenmarkKim Wildgaard, MD, Ph.d., Study chair, University Hospital of Copenhagen, Herlev, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247852
- Sponsor's protocol ID
- 101
- Status last verified
- Sep 2025
- First submitted
- 8 Jan 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT06247852
- Acronym / sponsor ID
- 101
- Conditions
- Cesarean Section Complications, Cesarean Section, Cesarean Delivery, Persistent Pain, Chronic Pain, SMS
- Keywords
- persistent pain, chronic pain, Danish cohort, cesarean section, cesarean delivery, acute on chronic pain, post operative pain, SMS questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 8 Feb 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.
In Denmark, around 12,700 patients undergo Cesarean delivery (CD) annually, constituting approximately 20% of all childbirths in the country. Worldwide, the number is increasing each year, with more than 20 million CD performed annually.
Postoperative pain after CD is typically moderate to severe in intensity and still constitutes a significant challenge, balancing effective pain relief and potential side effects. Correlations between moderate to severe acute pain and the development of persistent pain after CD is still unclear.
Postsurgical persistent pain is a significant, often unrecognized clinical problem that causes distress and diminishes the quality of life for patients. Despite advances in understanding the factors contributing to persistent postsurgical pain and an increased focus on identifying patients at risk, the management and prevention of postsurgical persistent pain are still inadequate.
It is important to gain further insights into this population, and we have a unique opportunity to do so by following the national cohort from the ongoing Danish multicenter cohort study on pain after cesarean section (ClinicalTrials.gov Identifier: NCT06012747) over an extended follow-up period.
This involves continued prospective registration of Patient-Reported Outcome Measures (PROM) collected by SMS-based questionnaires in the months and years after the CD, thereby investigating the occurrence of both acute and persistent pain after CD.
The outcomes are focused on pain levels, the impact of pain on physical function and neuropathic pain characteristics in the months and years following the CD. The study also aims to explore the relationship between persistent and acute pain.
Detailed description
The Study Protocol is attached in full-text (Study Documents).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients, aged > 18 years, who undergo planned cesarean delivery under spinal anesthesia.
Key inclusion criteria (4 listed)
- Patients who, after participating in the Danish multicenter cohort study on pain after cesarean delivery (ClinicalTrials.gov Identifier: NCT06012747), consent to continue to receive questionnaires about persistent pain.
- Planned cesarean delivery in spinal anesthesia
- Patients who speak and read Danish
- Patients with a smartphone that can receive an SMS with a link to a questionnaire that can be opened online.
Key exclusion criteria (1 listed)
- <18 years of age
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
Persistent pain
Time frame: after 6 months
The percentage of patients reporting pain equivalent to an NRS score > 3 after 6 months
23 secondary outcomes
Severe pain during the last 24 hours.
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Severe pain at rest during the last 24 hours.
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Use of analgesic medication in the past week due to pain (Paracetamol, Non-Steroidal Anti-Inflammatory Drug, opioid).
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain's affect on daily activities
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain's affect on engaging in strenuous physical activity.
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain's affect on meeting the infant's needs.
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain's affect on sleep.
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain's affect on mood.
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain/discomfort when sitting down or standing up from a chair.
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain/discomfort when walking on stairs.
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain/discomfort when getting in or out of bed.
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain/discomfort when carrying the infant.
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain/discomfort when sitting up for less than 30 minutes.
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain/discomfort if sitting up for more than 30 minutes.
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain/discomfort when moving around at home.
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain/discomfort if walking for more than 30 minutes.
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain/discomfort when bending down.
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain/discomfort during or after sexual intercourse.
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pins and needles, tingling or stabbing sensations in or around the area of the surgery?
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Electric shock like sensation or jabbing feelings in the skin area in or around the area of the surgery?
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Heat or burning sensations in or around the area of the surgery?
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain caused by the lightest of touches in or around the area of the surgery?
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
Pain caused by cold temperatures in or around the area of surgery?
Time frame: Assessments are conducted at 5 weeks, 2, 3, 6, and 12 months, and after that every 6 months until 3 years after surgery.
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 3 Sep 2025.
- 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.
Patricia Duch, MD principal investigator
University Hospital of Copenhagen, Hillerød, Denmark
Helene Nedergaard, MD, Ph.D study director
University Hospital of Southern Denmark, Kolding
Christoffer Jørgensen, Dr. Med. study director
University Hospital of Copenhagen, Hillerød, Denmark
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 Section Complications and Cesarean Section, run by Nordsjaellands Hospital 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 4 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 3 Sep 2025. 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?
Persistent pain (time frame: after 6 months). 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 3 Sep 2025.