Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study

NCT ID: NCT06247852

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 477 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-09-01

Brief 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.

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).

Conditions

Cesarean Section Complications; Cesarean Section; Cesarean Delivery; Persistent Pain; Chronic Pain; SMS; Questionnaire

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• <18 years of age

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nordsjaellands Hospital

OTHER

Sponsor Role: lead

Responsible Party

Patricia Duch

Consultant, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Duch, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Copenhagen, Hillerød, Denmark

Helene Nedergaard, MD, Ph.D

Role: STUDY_DIRECTOR

University Hospital of Southern Denmark, Kolding

Christoffer Jørgensen, Dr. Med.

Role: STUDY_DIRECTOR

University Hospital of Copenhagen, Hillerød, Denmark

Kim Wildgaard, MD, Ph.d.

Role: STUDY_CHAIR

University Hospital of Copenhagen, Herlev, Denmark

Locations

Department of Anesthesiology, Copenhagen University Hospital, North Zealand Hillerød

Hillerød, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

101

Identifier Type: -

Identifier Source: org_study_id