- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03269188
Incidence and Associated Factors of Persistent Postoperative Incision Scar Pain Following C/s in Mulago Hospital (PPOPinC/S)
August 30, 2017 updated by: Makerere University
prospective cohort study of women who underwent caesarean section in mulago hospital.
followed up for 2 months and assessed for development of persistent post operative pain at the incision site and its effect on quality of life.
incidence of persistent postoperative pain and associated factors determined.
Study Overview
Status
Completed
Conditions
Detailed Description
prospective cohort study of 277 women who underwent caesarean section in mulago hospital.
demographic, medical history, intraoperative, postoperative details, and perioperative levels of pain collected.
followed up by telephone interviews for 2 months and assessed for development of persistent post operative pain at the incision site and its effect on quality of life.
incidence of persistent postoperative pain and associated factors determined.
Study Type
Observational
Enrollment (Actual)
277
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
women scheduled to undergo both elective and emergency caesarean section in the obstetric theatres of mulago national referral hospital during the study period and meet the eligibility criteria.
Description
Inclusion Criteria:
- ASA I, II, and III.
- patient who has given informed consent.
Exclusion Criteria:
- patients who have no telephone contact
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
persistent postoperative pain at caesarean section incision scar site.
Time Frame: 2 months.
|
participant report pain at site of caesarean section incision site scar at 2 months after caesarean section.
|
2 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 6, 2016
Primary Completion (Actual)
October 10, 2016
Study Completion (Actual)
October 27, 2016
Study Registration Dates
First Submitted
August 30, 2017
First Submitted That Met QC Criteria
August 30, 2017
First Posted (Actual)
August 31, 2017
Study Record Updates
Last Update Posted (Actual)
August 31, 2017
Last Update Submitted That Met QC Criteria
August 30, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Persistent pain in C/S
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.