Clinical and Ultrasonographic Predictors of IUD Related Complications (NCT06806358) | Clinical Trial Compass
RecruitingNot Applicable
Clinical and Ultrasonographic Predictors of IUD Related Complications
Egypt200 participantsStarted 2025-02-01
Plain-language summary
* All patients fulfilling the selection criteria undergo complete clinical examination and detailed medical history obtained. Each patient had a Case Record Form (CRF) recording participants' name. number, previous deliveries and abortions, age, height, weight, BMI, LMP, past medical and surgical history and contraceptive history.
* All participants will be subjected to transvaginal ultrasound to measure uterine size, endometrial and myometrial thickness, uterine position, cervical length, cervical diameter and for detection of any contraindications for IUD insertion.
Power Doppler Energy (PDE) measurement for subendometrial microvascularization will be done and categorized as women with minor subendometrial vascularization (Classifications I and II) and major subendometrial vascularization (Classifications III, IV and V)
Who can participate
Age range
20 Years – 41 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:
* Age 20 -41 years
* BMI 18-25 kg/m2
* Women with any parity seeking contraception and choosing IUD as their preferred method after proper and thorough counseling
* Regularly menstruating women (duration of menstruation 3-7 days and length of cycle 22- 35 days).
* Not using any hormonal therapy or anticoagulation
Exclusion Criteria:
* Cervical abnormalities.
* Pregnancy or suspicion of pregnancy
* Congenital or acquired uterine anomalies which distort the uterine cavity (fibroids, endometrial polyps, cervical stenosis, bicornuate uterus, hypoplastic uterus \< 6 cm)
* Acute PID or a history of PID within the past 3 months
* Postpartum or post-abortion endometritis within the past 3 months
* Current STI or within the past 3 months (including cervicitis)
* Cervical cancer
* Endometrial cancer
* Malignant gestational trophoblastic disease
* Undiagnosed vaginal bleeding
* Hypersensitivity to any component in the IUD (copper)
* Less than 6 weeks postpartum.
* Neurological or psychological conditions that may affect pain sensation
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.