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 range20 Years – 41 Years
SexFEMALE
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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