FistulaNCT02770352
Fistula Formation and Successful Repair
An observational study of Fistula and HIV, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
Trial summary
The objective of this proposal is to create a database for obstetric fistula patients at Bwaila Hospital containing their demographics, obstetric history, fistula history, physical exam findings, intraoperative and postoperative results. Read more about this study
- Who is it for?
- Ages 12 to 45 years, women only
- How many people
- 1,817 participants
- Where
- 1 siteMalawi
- Study dates
- Oct 2012to 11 Sep 2019
- 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 12 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Participants are women admitted to Bwaila Hospital for repair of obstetric fistulas.
Who may be able to join
- Women aged 12 years and above
- Present to Bwaila Hospital with obstetric fistula
- Allow retrospective chart review
- Willing to provide consent
Who cannot join
- Not allow retrospective chart review
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Factors Surrounding Fistula Formation and Successful Repair at Bwaila Hospital, Lilongwe
The objective of this proposal is to create a database for obstetric fistula patients at Bwaila Hospital containing their demographics, obstetric history, fistula history, physical exam findings, intraoperative and postoperative results. Data collection will be prospective starting in 2011 upon institutional review board (IRB) approval to last a minimum of five years and will have a retrospective component tracing back to January 2010. Primary goals of data analysis will be to determine the risk factors for fistula formation, risk factors for poor surgical outcomes and long-term incontinence, social and economic impact of fistula repair, and the ability of various physical exam findings to predict likelihood of successful repair. It is expected that findings will lead to improved surgical management of obstetric fistulas both locally and internationally.
Read the detailed description
This is a prospective and retrospective chart review of a cohort of women aged 12 years and above who present to Bwaila Hospital with obstetric fistulas. Variables from existing subject records tracing back to January 2010 will be input into the REDCap database and analyzed. Prospective data collection will begin alongside obstetric fistula repairs upon IRB approval and will last for a minimum of 5 years.
A few variables were selected from the database for sample size determination:
- HIV prevalence In order to assess a statistically significant difference in HIV prevalence amongst fistula patients and the general population, with a projected prevalence of 25% in fistula patients and 15% in the general population based on prior studies, approximately 416 fistula patients would need to be enrolled in the study.
- Risk factors for failure of repair-Goh classification Type 4 In order to assess a statistically significant difference in failure of repair for fistula patients classified based on the Goh classification as Type4 (approximately 30% failure rate based on prior studies) and all other fistula patients (15% failure rate reported for uncomplicated fistulas), approximately 200 patients would need to be enrolled in the study.
It is estimated that about 200 fistula patients will be enrolled into the database every year. The study is expected to last a minimum of 5 years, for a total enrollment of 1250 patients.
Current Procedures For more than a year, the Freedom to Fight Fistula Foundation (FFFF) has sponsored a fistula repair program at Bwaila that has consisted of visiting fistula surgeons coming for short periods of time to conduct repairs. Since September 2011, a full time fistula surgeon has been on site at Bwaila hospital.
Referral to the FFFF at Bwaila occurs primarily via word-of-mouth, as currently demand highly exceeds capacity. As of now, there is a waiting list of approximately 50 fistula patients. Occasionally, the foundation makes visits to health centers to give educational presentations on obstetric fistulas, and distributes flyers advertising its services in the local community. Once the presence of a regular surgeon is established, and the waiting list is diminished, the foundation anticipates increasing its advertising through newspaper and radio, and by making regular visits to community events and district health centers.
Bwaila Hospital is a hospital located in Lilongwe designated for women. It provides basic, regular obstetric and gynecologic services.
Data Collection and Bwaila Hospital
Retrospective Arm A chart review of existing subject records tracing back to January 2010 will be conducted, and input in the REDCap database to the extent that it is available and complete.
Prospective Arm Nurses will obtain informed consent from all patients admitted to Bwaila Hospital for obstetric fistula evaluation to participate in the research study.
They will then interview the patients with a clinical history form. The information collected with the form will be relevant to the care of the patient, and is part of routine care for obstetric fistula patients.
The form includes demographic data, sexual history, obstetric history, and medical history, and a depression screening and diagnostic tool.
After the interview the patient will receive standard of care with their obstetrics doctor for their fistulas (this is not part of the study): assessed for the presence of an obstetric fistula; discuss possible repair; have repair; recuperate; discharged; return for follow-up visits at one month and three months to assess how the patient is doing.
At these visits patient will have 5 minute study interviews discussing their ability to control their urination, and also how well they are getting by in their community, both financially and socially.
Additional data will be extracted directly from the patient chart as a secondary chart review for the study, and will include a review of physical exam findings, preoperative findings, intraoperative findings, postoperative results and follow-up findings at the one-month and three-month review dates.
This data will be transferred from the patient charts to REDCap. All information collected will be de-identified.
- Keywords
- retrospective chart review, prospective chart review, fistula formation and repair, database, demographics of women with fistulas, internationally accepted risks factors for fistula formation
- Medical subject headings
- Fistula
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful obstetric fistula repair
Successful obstetric fistula repair is defined by having a negative dye test (no leakage of dye into the vagina after dye is infused into the bladder). Factors associated with successful obstetric fistula repair will be evaluated.
Measured: 3-months after obstetric fistula repair
Secondary outcomes (1)
Rates of depression among women undergoing obstetric fistula repair and associated factors
Participants will complete the patient health questionnaire (PHQ)-9, a standardized tool to diagnose depression before and after obstetric fistula repair. Factors associated with post-operative depression will be explored such as HIV, number of living children, and marital status.
Measured: 3-months 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 posted12 May 2016 (estimated)
- Study startOct 2012
- Primary completion11 Sep 2019
- Study completion11 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,817 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- Jennifer Tang, MD, MSCR, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770352
- Sponsor's protocol ID
- 11-2345
- Other IDs
- CID 1116
- Status last verified
- Feb 2020
- First submitted
- 5 May 2016
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Factors Surrounding Fistula Formation and Successful Repair at Bwaila Hospital, Lilongwe
- ClinicalTrials.gov ID
- NCT02770352
- Acronym / sponsor ID
- 11-2345
- Keywords
- retrospective chart review, prospective chart review, fistula formation and repair, database, demographics of women with fistulas, internationally accepted risks factors for fistula formation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,817 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Baylor College of Medicine
- Study start
- Oct 2012
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 11 Sep 2019 (actual)
- First posted
- 12 May 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 objective of this proposal is to create a database for obstetric fistula patients at Bwaila Hospital containing their demographics, obstetric history, fistula history, physical exam findings, intraoperative and postoperative results. Data collection will be prospective starting in 2011 upon institutional review board (IRB) approval to last a minimum of five years and will have a retrospective component tracing back to January 2010. Primary goals of data analysis will be to determine the risk factors for fistula formation, risk factors for poor surgical outcomes and long-term incontinence, social and economic impact of fistula repair, and the ability of various physical exam findings to predict likelihood of successful repair. It is expected that findings will lead to improved surgical management of obstetric fistulas both locally and internationally.
Detailed description
This is a prospective and retrospective chart review of a cohort of women aged 12 years and above who present to Bwaila Hospital with obstetric fistulas. Variables from existing subject records tracing back to January 2010 will be input into the REDCap database and analyzed. Prospective data collection will begin alongside obstetric fistula repairs upon IRB approval and will last for a minimum of 5 years.
A few variables were selected from the database for sample size determination:
- HIV prevalence In order to assess a statistically significant difference in HIV prevalence amongst fistula patients and the general population, with a projected prevalence of 25% in fistula patients and 15% in the general population based on prior studies, approximately 416 fistula patients would need to be enrolled in the study.
- Risk factors for failure of repair-Goh classification Type 4 In order to assess a statistically significant difference in failure of repair for fistula patients classified based on the Goh classification as Type4 (approximately 30% failure rate based on prior studies) and all other fistula patients (15% failure rate reported for uncomplicated fistulas), approximately 200 patients would need to be enrolled in the study.
It is estimated that about 200 fistula patients will be enrolled into the database every year. The study is expected to last a minimum of 5 years, for a total enrollment of 1250 patients.
Current Procedures For more than a year, the Freedom to Fight Fistula Foundation (FFFF) has sponsored a fistula repair program at Bwaila that has consisted of visiting fistula surgeons coming for short periods of time to conduct repairs. Since September 2011, a full time fistula surgeon has been on site at Bwaila hospital.
Referral to the FFFF at Bwaila occurs primarily via word-of-mouth, as currently demand highly exceeds capacity. As of now, there is a waiting list of approximately 50 fistula patients. Occasionally, the foundation makes visits to health centers to give educational presentations on obstetric fistulas, and distributes flyers advertising its services in the local community. Once the presence of a regular surgeon is established, and the waiting list is diminished, the foundation anticipates increasing its advertising through newspaper and radio, and by making regular visits to community events and district health centers.
Bwaila Hospital is a hospital located in Lilongwe designated for women. It provides basic, regular obstetric and gynecologic services.
Data Collection and Bwaila Hospital
Retrospective Arm A chart review of existing subject records tracing back to January 2010 will be conducted, and input in the REDCap database to the extent that it is available and complete.
Prospective Arm Nurses will obtain informed consent from all patients admitted to Bwaila Hospital for obstetric fistula evaluation to participate in the research study.
They will then interview the patients with a clinical history form. The information collected with the form will be relevant to the care of the patient, and is part of routine care for obstetric fistula patients.
The form includes demographic data, sexual history, obstetric history, and medical history, and a depression screening and diagnostic tool.
After the interview the patient will receive standard of care with their obstetrics doctor for their fistulas (this is not part of the study): assessed for the presence of an obstetric fistula; discuss possible repair; have repair; recuperate; discharged; return for follow-up visits at one month and three months to assess how the patient is doing.
At these visits patient will have 5 minute study interviews discussing their ability to control their urination, and also how well they are getting by in their community, both financially and socially.
Additional data will be extracted directly from the patient chart as a secondary chart review for the study, and will include a review of physical exam findings, preoperative findings, intraoperative findings, postoperative results and follow-up findings at the one-month and three-month review dates.
This data will be transferred from the patient charts to REDCap. All information collected will be de-identified.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants are women admitted to Bwaila Hospital for repair of obstetric fistulas.
Key inclusion criteria (4 listed)
- Women aged 12 years and above
- Present to Bwaila Hospital with obstetric fistula
- Allow retrospective chart review
- Willing to provide consent
Key exclusion criteria (1 listed)
- Not allow retrospective chart review
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
Successful obstetric fistula repair
Time frame: 3-months after obstetric fistula repair
Successful obstetric fistula repair is defined by having a negative dye test (no leakage of dye into the vagina after dye is infused into the bladder). Factors associated with successful obstetric fistula repair will be evaluated.
1 secondary outcome
Rates of depression among women undergoing obstetric fistula repair and associated factors
Time frame: 3-months 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 4 Sep 2020.
- Individual participant dataSharing planned: No
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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, MSCR 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 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 4 Sep 2020. 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?
Successful obstetric fistula repair (time frame: 3-months after obstetric fistula repair). 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 4 Sep 2020.