Aspirin for Prevention of Preeclampsia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Preeclampsia

Intervention / Treatment
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* Drug: aspirin 162 mg
* Drug: aspirin 81 mg
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: aspirin 162 mg<br>Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first | Drug: aspirin 162 mg<br>* Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first<br>* Other names: Active Comparator;|
| Active Comparator: aspirin 81 mg plus placebo<br>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 | Drug: aspirin 81 mg<br>* Aspirin 81mg one tablet once a day from recruitment until 37 weeks or labor whichever comes first<br>* Other names: active comparator;Drug: placebo<br>* placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first<br>* Other names: Placebo to asprin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With early Preeclampsia | 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of preeclampsia between 37 and 41 | The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy. | 6 months | 
| The number of cases of Fetal Growth Restriction | The number of cases of fetal growth restriction, defined as a fetal weight below the 10th percentile and an abnormal umbilical cord doppler that appear in both groups at any given time during pregnancy. | 6 months | 
| The number of cases of preterm birth | The number of cases delivered before 37 weeks gestation | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preeclampsia, low dose aspirin, high risk pregnancy