Chronic PainPPOPinC/SNCT03269188
Incidence and Associated Factors of Persistent Postoperative Incision Scar Pain Following C/s in Mulago Hospital
An observational study of Chronic Pain, run by Makerere University.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Chronic Pain
- How many people
- 277 participants
- Where
- No sites listed yet
- Study dates
- 6 Jul 2016to 27 Oct 2016
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- ASA I, II, and III.
- patient who has given informed consent.
Who cannot join
- patients who have no telephone contact
About this study
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.
Read the 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.
- Conditions
- Chronic Pain
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
persistent postoperative pain at caesarean section incision scar site.
participant report pain at site of caesarean section incision site scar at 2 months after caesarean section.
Measured: 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start6 Jul 2016
- Primary completion10 Oct 2016
- Study completion27 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269188
- Sponsor's protocol ID
- Persistent pain in C/S
- Acronym
- PPOPinC/S
- Status last verified
- Aug 2017
- First submitted
- 30 Aug 2017
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Associated Factors of Persistent Postoperative Incision Scar Pain Following C/s in Mulago Hospital
- ClinicalTrials.gov ID
- NCT03269188
- Acronym / sponsor ID
- PPOPinC/S / Persistent pain in C/S
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- 6 Jul 2016 (actual)
- Primary completion
- 10 Oct 2016 (actual)
- Study completion
- 27 Oct 2016 (actual)
- First posted
- 31 Aug 2017 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- ASA I, II, and III.
- patient who has given informed consent.
Key exclusion criteria (1 listed)
- patients who have no telephone contact
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 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.
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 31 Aug 2017.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Makerere University.
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 2 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 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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 postoperative pain at caesarean section incision scar site. (time frame: 2 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 31 Aug 2017.