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

The University of Texas System (UT)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pre-Eclampsia; Obesity; Hypertension in Pregnancy

Treatments: Drug: Aspirin 162 mg; Drug: Aspirin 81 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03961360

HSC-MS-18-1073

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

220 participants in 2 patient groups

162 mg/day Aspirin

Experimental group

Treatment:

Drug: Aspirin 162 mg

81 mg/day Aspirin

Active Comparator group

Treatment:

Drug: Aspirin 81 mg