Ultrasonographic and Hormonal Characteristics of Malawian Women With and Without Obstetric Fistula (NCT01891149) | Clinical Trial Compass
CompletedNot Applicable
Ultrasonographic and Hormonal Characteristics of Malawian Women With and Without Obstetric Fistula
Malawi112 participantsStarted 2012-12
Plain-language summary
This study is a cross-sectional study of 110 Malawian women to compare the ultrasonographic and hormonal characteristics of women and without obstetric fistula.
Hypothesis #1: Women with obstetric fistula have a mean cervical length measurement that is at least 10 mm shorter than the mean cervical length measurement of similar women without obstetric fistula.
Hypothesis #2: Evaluation of the hormonal and ultrasonographic characteristics of women with obstetric fistula will allow us to assess the cause of amenorrhea in these women.
Who can participate
Age range
18 Years – 45 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
. Presentation to the Fistula Care Centre in Lilongwe for medical evaluation
. Ability to consent for study participation in Chichewa
. Female aged 18-45 years
. Willingness to undergo pelvic ultrasound for assessment of pelvic organs
Exclusion criteria
. No history of pregnancy
. History of hysterectomy
. Current pregnancy or pregnancy within the past six weeks
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.
1This study compared women with and without obstetric fistula in Malawi — since it's already completed, would the findings from it change anything about how you would approach my diagnosis or care for obstetric fistula?
2The study measured cervical length as a primary outcome — what does cervical length tell us about obstetric fistula, and is that something you think is relevant to my specific situation?
3Since this was an observational study rather than a treatment trial, it wasn't testing a new therapy — does that mean I should be looking at separate trials if I'm hoping to find an experimental treatment option for my condition?
4This research was done specifically with women in Malawi, so I'm wondering whether those findings would apply to my own background and circumstances — is the data relevant enough to inform decisions about my care?
5Given that this study has already been completed, would it be worth asking whether the results have been published, and whether those results point toward any next steps or follow-up studies I should know about?
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.