Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-25 @ 2:26 AM
NCT ID:
NCT03492034
Eligibility Criteria:
Inclusion Criteria:
1. Pregnant woman aged between 18 to 40 years old.
2. Scheduled for elective cesarean section at gestational age between 37 to 42 weeks.
3. Body mass index between 19-30 kg/m2
4. Seeking contraception after delivery.
Exclusion Criteria:
1. History of menorrhagia or severe dysmenorrhea.
2. History of pelvic inflammatory disease or current pelvic infection (ex: puerperal sepsis, purulent cervicitis).
3. Patients who have bleeding disorders.
4. Anemia (Hb \< 9 g %).
5. Chronic depilating diseases reducing immunity such as Diabetes.
6. Structural uterine anomaly or large uterine fibroids distorting anatomy.
7. History of previous IUD expulsion or removal for complications.
8. Unexplained uterine bleeding.
9. Copper allergy or Wilson disease.
10. Gestational trophoblastic disease with persistently elevated Beta HCG.
11. Predisposing factor to postoperative infection (e.g. rupture of membranes prior to admission or delivery of a stillborn baby at cesarean section).
12. Complications during cesarean section e.g. postpartum hemorrhage.
13. Cesarean section during placenta previa.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03492034
Study Brief:
Protocol Section:
NCT03492034