FistulaNCT02685878
Outcomes of Women After Obstetric Fistula Repair
An observational study of Fistula and HIV, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- How many people
- 297 participants
- Where
- 1 siteMalawi
- Study dates
- Sep 2015to 5 Nov 2018
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 300 women 1-3 years after they have undergone obstetric fistula repair at the Fistula Care Center in Lilongwe, Malawi.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical, Psychological, and Reproductive Outcomes of Women After Obstetric Fistula Repair
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.
Read the detailed description
Eligible participants will be identified from an existing, secure database. Participants will be contacted and traced. They will then be invited to participate in the study. If a participant agrees to participate in the study, they will undergo informed consent by trained study staff, using IRB-approved informed consent forms. They will then undergo a 1-hour pad weight, complete demographic data, complete an incontinence-related quality of life metric, and complete a depression metric.
1-hour pad weight: Use of the 1-hour pad weights have been recommended as an objective measure of treatment outcome for anti-incontinence procedures. After a woman has agreed to enroll in the study and has given written consent, she will be asked to complete a 1-hour pad weight. Pad weights will be measured through having participants sit on a pre-weighed pad for exactly one hour and re-weighing the same pad. The weight of the pad before and after will be recorded and the difference between the two will be used as the pad weight. The pad weight represents the degree of urinary leakage a woman is experiencing. In continent populations, this weight is <1.5 grams. The research assistant will use a calibrated portable scale and stopwatch to ensure accurate recording of these weights. During this time, the remainder of the survey will be conducted.
Demographic Data: Demographic data for each participant will be collected at the time of enrollment and after a written consent has been obtained. This includes information about the patient's age, place of residence, HIV status, education attainment, living arrangement, number of pregnancies and living children, and symptoms of urinary or fecal leakage.
Incontinence-related Quality of Life Metric: To assess OF repair success and continence, participants will be asked about any leakage symptoms with the Kings' Health Questionnaire.
Depression Metric:The 9-question Patient Health Questionnaire (PHQ-9) will be used to assess repaired OF participants for depression.
- Keywords
- urinary continence, prevalence of depression, reproductive outcomes, quality of life, HIV status, obstetric fistula
- Medical subject headings
- Fistula
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (1)
Depression after obstetric fistula repair
The PHQ-9 will be administered and women who score a 10 or greater will be considered to have major depression.
Measured: 1-3 years after obstetric fistula repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completion5 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FistulaStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Tang, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685878
- Sponsor's protocol ID
- UNCPM 21502
- Status last verified
- Nov 2018
- First submitted
- 22 Jan 2016
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29179770
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical, Psychological, and Reproductive Outcomes of Women After Obstetric Fistula Repair
- ClinicalTrials.gov ID
- NCT02685878
- Acronym / sponsor ID
- UNCPM 21502
- Keywords
- urinary continence, prevalence of depression, reproductive outcomes, quality of life, HIV status, obstetric fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- 5 Nov 2018 (actual)
- First posted
- 19 Feb 2016 (estimated)
- 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.
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.
Detailed description
Eligible participants will be identified from an existing, secure database. Participants will be contacted and traced. They will then be invited to participate in the study. If a participant agrees to participate in the study, they will undergo informed consent by trained study staff, using IRB-approved informed consent forms. They will then undergo a 1-hour pad weight, complete demographic data, complete an incontinence-related quality of life metric, and complete a depression metric.
1-hour pad weight: Use of the 1-hour pad weights have been recommended as an objective measure of treatment outcome for anti-incontinence procedures. After a woman has agreed to enroll in the study and has given written consent, she will be asked to complete a 1-hour pad weight. Pad weights will be measured through having participants sit on a pre-weighed pad for exactly one hour and re-weighing the same pad. The weight of the pad before and after will be recorded and the difference between the two will be used as the pad weight. The pad weight represents the degree of urinary leakage a woman is experiencing. In continent populations, this weight is <1.5 grams. The research assistant will use a calibrated portable scale and stopwatch to ensure accurate recording of these weights. During this time, the remainder of the survey will be conducted.
Demographic Data: Demographic data for each participant will be collected at the time of enrollment and after a written consent has been obtained. This includes information about the patient's age, place of residence, HIV status, education attainment, living arrangement, number of pregnancies and living children, and symptoms of urinary or fecal leakage.
Incontinence-related Quality of Life Metric: To assess OF repair success and continence, participants will be asked about any leakage symptoms with the Kings' Health Questionnaire.
Depression Metric:The 9-question Patient Health Questionnaire (PHQ-9) will be used to assess repaired OF participants for depression.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 women 1-3 years after they have undergone obstetric fistula repair at the Fistula Care Center in Lilongwe, Malawi.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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
The prevalence of participants with a 1-hour pad weight over 1.5 grams (marker of incontinence) will be be calculated.
Time frame: 1 hour
To assess OF repair success and continence, patients will complete a 1-hour pad weight, which correlates to urinary incontinence.
1 secondary outcome
Depression after obstetric fistula repair
Time frame: 1-3 years after obstetric fistula repair
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 13 Nov 2018.
- Derived from this study: PubMed 29179770Kopp 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.
- Individual participant dataSharing planned: Undecided
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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.
Jennifer Tang, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fistula and HIV, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
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 4 inclusion and 3 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 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The prevalence of participants with a 1-hour pad weight over 1.5 grams (marker of incontinence) will be be calculated. (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02685878, which also lists 1 linked publication.
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 13 Nov 2018.