Predicting complications related to IUD insertion using clinical and ultrasound assessments
Clinical and Ultrasonographic Predictors of IUD Related Complications: A Prospective Cohort Study
NA · Cairo University · NCT06806358
This study is testing if certain medical exams and ultrasound checks can help predict complications for women aged 20-41 getting an IUD inserted.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 20 Years to 41 Years |
| Sex | Female |
| Sponsor | Cairo University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06806358 on ClinicalTrials.gov |
What this trial studies
This study evaluates clinical and ultrasonographic predictors of complications associated with intrauterine device (IUD) insertion. Participants aged 20-41 years with a BMI of 18-25 kg/m2 will undergo a thorough clinical examination and detailed medical history collection. Transvaginal ultrasound will be performed to assess uterine size, endometrial and myometrial thickness, and other relevant parameters. Additionally, Power Doppler Energy measurements will categorize subendometrial microvascularization to identify potential risks for IUD insertion.
Who should consider this trial
Good fit: Ideal candidates are women aged 20-41 years with a BMI between 18-25 kg/m2 who are seeking contraception and prefer IUDs.
Not a fit: Patients with cervical abnormalities, pregnancy, or certain uterine anomalies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of IUD insertion by identifying patients at risk for complications.
How similar studies have performed: While similar studies have explored predictors of IUD complications, this specific approach combining clinical and ultrasound assessments is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cairo
- Kasr Alainy medical school — Cairo, Egypt (RECRUITING)
Study contacts
- Principal investigator: Ahmed Maged — Cairo University
- Study coordinator: Ahmed Maged
- Email: ahmedmaged@cu.edu.eg
- Phone: +201005227404
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: IUCD Complication