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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.