Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

To compare the incidence of preeclampsia in obese pregnant women (BMI greater than 30) with a singleton gestation at less than 20 weeks and either a history of preeclampsia in a prior pregnancy or stage I hypertension or pre-gestational diabetes who are randomized to either 81mg/day aspirin or 162mg/day aspirin.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Aspirin

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