Aspirin for Prevention of Preeclampsia

Aswan University Hospital

Status: Unknown

Conditions: Preeclampsia

Treatments: Drug: aspirin 81 mg; Drug: aspirin 162 mg; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03726177

aswu 194/7/18

Details and patient eligibility

About

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,

Full 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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women presenting prior to 17+0 weeks' gestation.
• Moderate to high risk of preeclampsia.
• One or more of the following: previous history of preeclampsia, antiphospholipid antibodies, pre-existing diabetes, pre-existing hypertension, pre-existing renal disease, autoimmune disease, nulliparity, family history of preeclampsia, elevated BMI > 25, and maternal age <20 or >35.
• Give written informed consent.

Exclusion criteria

• Multiple gestations,
• fetal aneuploidy
• major fetal structural anomaly
• bleeding disorder
• allergy to aspirin
• women already on aspirin or heparin.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups

aspirin 162 mg

Active Comparator group

Description:

Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first

Treatment:

Drug: aspirin 162 mg

aspirin 81 mg plus placebo

Active Comparator group

Description:

Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first plus placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first

Treatment:

Drug: placebo

Drug: aspirin 81 mg