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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT03961360
Eligibility Criteria:
Inclusion Criteria
* A singleton gestation at less than 20 weeks at time of enrollment, with a BMI greater than or equal to 30 and one of the following:
1\. History of preeclampsia in a prior pregnancy
* Diagnosis will be obtained by review of records, and if unavailable then patient history. Preeclampsia diagnosis may be made in antepartum or postpartum period.
OR 2. At least stage I hypertension during pregnancy
* Stage I hypertension is defined as a systolic blood pressure between 130- 139 mm Hg or diastolic blood pressure between 80-89 mm Hg21
* This blood pressure criteria is met regardless of medication usage
* The patient must have a blood pressure reading ≥ 130-139/80-89 mm Hg at least during 1 clinic visit during the current pregnancy; before or at time of enrollment
OR
3\. Pre-gestational diabetes
* Type 1 and Type 2 diabetics are included
* Gestational diabetes mellitus diagnosed prior to 20 weeks gestational age will also be included
Exclusion Criteria
* Known allergy/prior adverse reaction/any medical condition where aspirin is contraindicated
* Already on aspirin prior to pregnancy
* Baseline renal Disease
* Baseline proteinuria identified at time of enrollment, defined as urine analysis with 3+ protein, or urine protein to creatinine ratio ≥ 0.3
* Systemic Lupus Erythematosus
* Seizure disorder on medications
* HIV positive status
* Known major fetal anomalies
* Multifetal gestation
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03961360
Study Brief:
Protocol Section:
NCT03961360