NCT03269188

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2016

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
Last Updated

August 31, 2017

Status Verified

August 1, 2017

Enrollment Period

3 months

First QC Date

August 30, 2017

Last Update Submit

August 30, 2017

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 months.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- ASA I, II, and III.
  • patient who has given informed consent.

You may not qualify if:

  • patients who have no telephone contact

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2017

First Posted

August 31, 2017

Study Start

July 6, 2016

Primary Completion

October 10, 2016

Study Completion

October 27, 2016

Last Updated

August 31, 2017

Record last verified: 2017-08