Early Prevention of Preeclampsia Study

Study Overview
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Brief Summary
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This is a randomized controlled trial to estimate the efficacy of low dose aspirin for preventing preeclampsia in women identified as high risk. The investigators hypothesize that the risk of preeclampsia in women identified by a first trimester multiparameter predictive model to be at high risk will be significantly reduced by initiating low dose aspirin early in pregnancy.

Detailed Description
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This will be a randomized control trial to estimate the efficacy of low dose aspirin in preventing preeclampsia in women identified in the first trimester to be at high risk. We will also obtain maternal blood, cord blood and placenta specimen for basic science studies to attempt to dissect biological mechanisms of aspirin effects. In addition we will conduct a cost-benefit analysis to determine the cost effectiveness of screening and using aspirin prophylaxis for screen positive women. Rationale for Design: The randomized control trial is the 'gold standard' of research design. Other designs such as case-control, retrospective cohort and prospective cohort are limited by potential bias and confounding. Randomly assigning subjects to different interventions minimizes selection bias. The random assignment also results in groups that are likely to be similar with regards to important confounding variables. This minimizes confounding by both measured and unmeasured factors. While random allocation does not guarantee the groups will be identical, it does ensure that any differences between them are due to chance alone. Finally, randomization produces groups that are random samples of the population. This permits use of standard statistical tests that are based on probability theory.

Official Title
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Early Prediction and Aspirin for Prevention of Preeclampsia

Conditions
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Preeclampsia

Intervention / Treatment
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* Drug: Aspirin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton pregnancy undergoing ultrasound examination at 9 0/7 - 14 6/7 weeks any one or more factors identified as high risk from the identified risk factors: Chronic hypertension, prepregnancy diabetes mellitus, previous preeclampsia, obesity (BMI >30), bilateral uterine artery notches preeclampsia risk score greater than 6, low PAPP-A ( < 0.52 MoM) Exclusion Criteria: Multiple gestations, fetal aneuploidy major fetal structural anomaly bleeding disorder allergy to aspirin women already on aspirin or heparin.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspirin<br>Aspirin 81mg one tablet once a day from recruitment until 37 weeks or labor whichever comes first | Drug: Aspirin<br> <br> |
| Placebo Comparator: placebo<br>placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Preeclampsia | Preeclampsia diagnosed per ACOG criteria: Blood pressure greater than 140/90 on 2 occasions 6 hrs apart and significant proteinuria (greater than 300mg in 24hrs). | within 3 months prior to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With IUGR, Early Preeclampsia, Severe Preeclampsia, Gestational Hypertension, Preterm Birth, Stillbirth, Placental Abruption, Antepartum Hemorrhage, Neonatal Death, NICU Admission, Miscarriage | Intrauterine growth restriction (IUGR) - estimated fetal weight less than 10th percentile early preeclampsia - preeclampsia delivered prior to 34 weeks severe preeclampsia - blood pressure greater then 160/110 gestational hypertension - hypertension without features of preeclampsia preterm birth, stillbirth, placental abruption, antepartum hemorrhage, neonatal death, NICU admission, miscarriage. Statistical significance not reported due to the low recruitment and poor patient compliance. | within 3 months of delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preeclampsia, Aspirin