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

Purpose

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.

Conditions

  • Pre-Eclampsia
  • Hypertension in Pregnancy
  • Obesity

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
162 mg/day Aspirin
  • Drug: Aspirin 162 mg
    Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Active Comparator
81 mg/day Aspirin
  • Drug: Aspirin 81 mg
    Low dose aspirin was initially reported as having a beneficial effect at preeclampsia

More Details

Status
Active, not recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact