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NCT06012747

Pain After Cesarean Section - A Danish Multicenter Cohort Study.

Completed Last updated 11 June 2024
What this trial tests

trial testing Questionnaire in Pain in 752 participants. Completed in 31 May 2024.

Timeline
1 September 2023
Primary endpoint
31 May 2024
31 May 2024

Quick facts

Lead sponsorNordsjaellands Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment752
Start date1 September 2023
Primary completion31 May 2024
Estimated completion31 May 2024
Sites19 locations across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

Nordsjaellands Hospital

Who can join

Adults 18 to 50, female only, with Pain or Cesarean Section. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pain after a cesarean section is of moderate to severe intensity. A Danish multicenter study from 2021 used an obstetric Quality of Recovery score 24 hours after the cesarean section and found that 45% of 861 patients had experienced very severe pain during recovery. This result was surprisingly high but also unspecific. Therefore, the investigators aim to investigate the intensity of pain experienced by patients at specific time intervals after the cesarean section e.g., every 6th hour. Additionally, the investigators will examine whether the pain has an impact on important functions for both the patients and the newborns, as well as assess the overall morphine consumption. All Danish regions have approved the REDCap database as a secure way to collect and store data. REDCap can also send encrypted links that can be converted into SMS messages sent to the participants' mobile phones at fixed intervals, allowing participants to enter data directly into the secure system. The investigators also aim to feasibility test the system. When a child is delivered by cesarean section, it is an expectation that the mother can take care of herself and the baby a few hours after the surgery. However, severe pain can hinder this. Therefore, it is important to investigate whether pain relief for our patients is sufficient. Based on response rates and the frequency of outcomes, data from this observational study can support the design of a future national multicenter randomized controlled trial (RCT) with a focus on postoperative pain intervention. The incidences of binary outcome measures and standard deviations of continuous outcome measures will support the sample size calculations for our RCT.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Pain and adverse effects after caesarean delivery: A nationwide prospective cohort study.
    Duch P, Wikkelsø A, Jørgensen CC, Jakobsen JC, et al · · 2026 · PMID 40956058 · DOI 10.1097/eja.0000000000002277

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Trials testing the same drug.

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Trials by the same sponsor.

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