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:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT03907735
Eligibility Criteria:
Inclusion Criteria:
* Women age 18-50
* Gestational age 14-26 weeks; or 6-13 weeks, 37-42 weeks, or non-pregnant (controls)
* Undergoing another planned surgical procedure with anesthesia (suction D\&C, D\&E, gravid hysterectomy, cesarean section, or laparoscopic tubal ligation)
* Able to give informed consent in English or Spanish
Exclusion Criteria:
To optimize biopsy safety, we will exclude patients with anticipated difficult cases, that have additional risks of hemorrhage, or those with features that limit ultrasound visualization.
Increased risk of hemorrhage:
* Anemia (Hgb \< 9)
* Anticoagulation, bleeding disorder, or coagulopathy
* Multiple gestation
* Infection or sepsis
For ultrasound-guided procedures:
* Obese, BMI ≥ 40
* History of ≥2 cesarean sections
* Large fibroids or uterine anomalies obstructing view
* Other poor visualization
* Thin myometrium \< 1cm
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03907735
Study Brief:
Protocol Section:
NCT03907735