Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida (NCT03961360) | Clinical Trial Compass
CompletedPhase 2/3
Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida
United States220 participantsStarted 2019-05-06
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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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
What they're measuring
1
Number of Participants With Preeclampsia Diagnosis With Severe Features Based on Clinician Diagnosis
Timeframe: 3-7 months
Trial details
NCT IDNCT03961360
SponsorThe University of Texas Health Science Center, Houston