TVS, SHG, and MRI in Uterine Niche (NCT07279181) | Clinical Trial Compass
CompletedNot Applicable
TVS, SHG, and MRI in Uterine Niche
China60 participantsStarted 2024-06-01
Plain-language summary
Uterine niche is a defect formed by poor healing of the lower uterine myometrium after cesarean section, defined as a depression of at least 2mm in the uterine myometrium at the cesarean scar; it is associated with gynecological symptoms and even life-threatening pregnancy complications, so accurate imaging evaluation is crucial for diagnosis, symptom grading, and treatment planning. Currently, transvaginal ultrasound (TVS), saline hysterosonography (SHG), and magnetic resonance imaging (MRI) are commonly used for evaluation, but there are controversies about the consistency of their measurements and repeatability of results. This observational study, conducted at the International Peace Maternity and Child Health Hospital affiliated with Shanghai Jiao Tong University School of Medicine, included women diagnosed with uterine niche.
Who can participate
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:
* Women (18-45 years) diagnosed with CSD at our center.
* Women having postmenstrual spotting after CS
* Signed informed consent.
Exclusion Criteria:
* Women who has a positive urine pregnancy test.
* Presence of an intrauterine device.
* With poor image quality from image will be excluded.
* Refuse to participate in this study.
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
Detection rates of niches
Timeframe: Periprocedural
Trial details
NCT IDNCT07279181
SponsorInternational Peace Maternity and Child Health Hospital