Outcomes of Women After Obstetric Fistula Repair

NCT02685878 | Completed

• 1 other identifier: UNCPM 21502
• Study Type: observational
• Target: 297
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to describe the long-term surgical success, quality of life, prevalence of depression, fertility rates, and pregnancy outcomes of patients who have undergone obstetric fistula repair. This will be a study involving up to 300 women 1-3 years after they have undergone obstetric fistula repair at the Fistula Care Center in Lilongwe, Malawi. Patients who underwent obstetric fistula repair between January 1, 2012 and July 31, 2014 will be identified from an existing database of fistula patients. They will then be contacted and invited to participate in the study. Consented patients will complete a 1-hour pad weight to evaluate urinary continence, a demographic questionnaire, an incontinence-related quality of life metric, and a depression metric. The data will be analyzed and then disseminated to stakeholders.

Conditions

Fistula; HIV

Keywords

urinary continence; prevalence of depression; reproductive outcomes; quality of life; HIV status; obstetric fistula

Outcome Measures

Primary Outcomes (1)

• The prevalence of participants with a 1-hour pad weight over 1.5 grams (marker of incontinence) will be be calculated.

  To assess OF repair success and continence, patients will complete a 1-hour pad weight, which correlates to urinary incontinence.

  1 hour

Secondary Outcomes (1)

• Depression after obstetric fistula repair

  1-3 years after obstetric fistula repair

Other Outcomes (2)

• Number of fertile women able to achieve pregnancy after fistula repair

  1-3 years after obstetric fistula repair

• Quality of life of women after fistula repair

  1-3 years after obstetric fistula repair

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

300 women 1-3 years after they have undergone obstetric fistula repair at the Fistula Care Center in Lilongwe, Malawi.

You may qualify if:

• Study participants who have had an obstetric fistula repair performed at the Fistula Care Center between January 1, 2012 and July 31, 2014
• Women that currently reside within the districts of Lilongwe, Dedza, Kasungu, Salima, Dowa, Ntcheu, Nkhotakota, Mchinji, Ntchisi, and Mzimba will be traced.
• Ability to speak Chichewa or English fluently
• Current age 18 years or above

You may not qualify if:

• Participants who did not have an obstetric fistula repair
• Participants who have deceased since their obstetric fistula repair
• Participants who do not currently reside within the districts of Lilongwe, Dedza, Kasungu, Salima, Dowa, Ntcheu, Nkhotakota, Mchinji, Ntchisi, and Mzimba

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Project

Lilongwe, Malawi

Location

Related Publications (1)

• Kopp DM, Wilkinson J, Bengtson A, Chipungu E, Pope RJ, Moyo M, Tang JH. Fertility outcomes following obstetric fistula repair: a prospective cohort study. Reprod Health. 2017 Nov 28;14(1):159. doi: 10.1186/s12978-017-0415-1.

  PMID: 29179770 DERIVED

MeSH Terms

Conditions

Fistula

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Tang, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: February 19, 2016
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: November 5, 2018
• Last Updated: November 13, 2018

Record last verified: 2018-11

Locations

MA (1)