Outcomes of Women After Obstetric Fistula Repair (NCT02685878) | Clinical Trial Compass
CompletedNot Applicable
Outcomes of Women After Obstetric Fistula Repair
Malawi297 participantsStarted 2015-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Participants who did not have an obstetric fistula repair
. Participants who have deceased since their obstetric fistula repair
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The prevalence of participants with a 1-hour pad weight over 1.5 grams (marker of incontinence) will be be calculated.
. Participants who do not currently reside within the districts of Lilongwe, Dedza, Kasungu, Salima, Dowa, Ntcheu, Nkhotakota, Mchinji, Ntchisi, and Mzimba