Comparison of Two Doses (81 mg Versus 162mg) of Aspirin for the Prevention of Preeclampsia in High-Risk Pregnant Women: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Number of Participants With early Preeclampsia
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
both participants and researchers will be blinded to the intervention given.
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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 >
- •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.
Arms & Interventions
aspirin 162 mg
Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first
Intervention: aspirin 162 mg (Drug)
aspirin 81 mg plus placebo
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
Intervention: aspirin 81 mg (Drug)
aspirin 81 mg plus placebo
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
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants With early Preeclampsia
Time Frame: 6 months
The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy.Blood pressure greater than 140/90 on 2 occasions 6 hrs apart and significant proteinuria (greater than 300 mg in 24 hrs) before 34 weeks gestation
Secondary Outcomes
- The number of cases of Fetal Growth Restriction(6 months)
- Prevention of preeclampsia between 37 and 41(6 months)
- The number of cases of preterm birth(6 months)
Investigators
hany farouk
Principal Investigator
Aswan University Hospital