NCT03961360

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

Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida: An Open Label, Comparative Effectiveness, Randomized Controlled Trial (ASPREO Trial)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pre-Eclampsia
• Hypertension in Pregnancy
• Obesity

Interventions

Type	Name	Description
DRUG	Aspirin 81 mg	Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
DRUG	Aspirin 162 mg	Low dose aspirin was initially reported as having a beneficial effect at preeclampsia

Timeline

• Start date: 2019-05-06
• Primary completion: 2023-04-10
• Completion: 2023-04-10
• First posted: 2019-05-23
• Last updated: 2024-05-08
• Results posted: 2024-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study