Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In Trans-Abdomi… (NCT02733952) | Clinical Trial Compass
UnknownPhase 3
Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In Trans-Abdominal Myomectomy
Egypt70 participantsStarted 2015-08
Plain-language summary
Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In Trans-Abdominal Myomectomy
Who can participate
Age range
20 Years – 40 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:
* • Women in the reproductive age (20 - 40 years) diagnosed as having uterine fibroids who are consenting to have trans-abdominal myomectomy in the postmenstrual period diagnosed by:
Clinical symptoms and signs:
* Abnormal uterine bleeding (menorrhagia or (and) metrorrhagia).
* Pain (dull aching lower abdominal pain or dysmenorrhea).
* Pressure symptoms (dyspareunia, dysuria, dyschezia or (and) backache).
* Progressive abdominal enlargement (abdominal swelling).
All women with clinical presentation suggestive of uterine fibroid will undergo abdominal and trans-vaginal ultrasound to confirm the clinical diagnosis and to exclude patients with:
* Submucous uterine myomas.
* Cervical or supracervical myomas.
* Broad ligamentary and pedunculated myomas.
* Associated pelvic pathology.
Ultrasound criteria of uterine fibroids of included patients:
* Maximum diameter of the largest fibroid is greater than 4cm.
* Maximum number of uterine myomas is not to be more than 5 myomas.
* Uterine fibroid may be subserous or intramural.
Exclusion Criteria:
* Obesity (body mass index \>30 kg/m2).
* Cardiac, endocrine, pulmonary or hematological disease (including anemia; hemoglobin level below 10gm/dl).
* Patients known to be allergic to tranexamic acid.
* Patients who received pre-operative hormonal therapy (such as a GnRH analogue).
* Patients presented by or with suspected malignant gynecological disease.
* Patients diagnosed as having submucous uterine fibroids, c…
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
Estimated intra-operative blood loss measured in milliliters