NCT03726177

Aspirin for Prevention of Preeclampsia

Comparison of Two Doses (81 mg Versus 162mg) of Aspirin for the Prevention of Preeclampsia in High-Risk Pregnant Women: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Aswan University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Prophylaxis with low-dose aspirin has been recommended to prevent preeclampsia, the rationale being that hypertension and abnormalities of coagulation in this disease are caused in part by an imbalance between vasodilating and vasoconstricting prostaglandins. Low-dose aspirin therapy inhibits thromboxane production more than prostacyclin production and therefore should protect against vasoconstriction and pathologic blood coagulation in the placenta. Initially, several single-center trials, mostly among women at increased risk for preeclampsia, demonstrated a substantial reduction in the risk of proteinuric hypertension as well as reductions in the incidences of preterm birth, infants small for gestational age, and perinatal death,

Detailed description

This will be a randomized control trial to estimate the efficacy of two doses (80 mg versus 160 mg) of aspirin for prevention of preeclampsia in High-Risk Pregnant Women identified in the first trimester to be at high risk.

Conditions

• Preeclampsia

Interventions

Type	Name	Description
DRUG	aspirin 162 mg	Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first
DRUG	aspirin 81 mg	Aspirin 81mg one tablet once a day from recruitment until 37 weeks or labor whichever comes first
DRUG	placebo	placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first

Timeline

• Start date: 2018-12-01
• Primary completion: 2020-11-30
• Completion: 2021-01-01
• First posted: 2018-10-31
• Last updated: 2019-01-10

Locations

1 site across 1 country: Egypt