162 mg of Aspirin for Prevention of Preeclampsia

Study Overview
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Brief Summary
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This is a study to assess if 162 mg of aspirin will decrease rates of preeclampsia in pregnant patients compared to 81 mg of aspirin.

Detailed Description
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After screening to meet inclusion criteria, pregnant patients at the Family Medicine Clinic will be asked to take 162 mg aspirin daily for 6 months, starting at about 12 weeks gestation and continued until the end of pregnancy. They will be monitored every 4 weeks until week 28, then every 2 weeks until week 36, and then weekly from week 36 on. Participants will be screened at these visits for medication compliance (taking, missed doses, side effects, etc). Patients will be subject to lab work as is routinely indicated for preeclampsia. At the end of the study period, accumulated study data will be compared with historical data from the Family Medicine Clinic on rates of preeclampsia and outcomes in patients taking 81 mg for preeclampsia prevention.

Official Title
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162 mg of Aspirin for Prevention of Preeclampsia

Conditions
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Preeclampsia

Intervention / Treatment
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* Drug: Aspirin 162 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any pregnant patient at Peoria FMC Hx of pre-eclampsia Multifetal gestation Chronic hypertension Type 1 or 2 diabetes Autoimmune disease Renal disease Nulliparity Obesity Family Hx of pre-eclampsia Sociodemographic characteristics Age >= 35 years of age Personal history factors (LBW, SGA, > 10-year pregnancy interval, adverse pregnancy outcomes Exclusion Criteria: At high risk of side effects from ASA therapy Hx of hemorrhagic stroke Hx of GI bleed, G6PD Liver disease NSAID or Salicylate allergy) Patients confirmed to be not compliant with therapy
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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention with 162 mg aspirin<br>Aspirin 162 mg daily for prevention of preeclampsia in pregnant patients at Family Medicine Clinic | Drug: Aspirin 162 mg<br>* Daily aspirin 162 mg during pregnancy to prevent preeclampsia<br>* Other names: Aspirin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with preeclampsia | Dangerous pregnancy complication characterized by high blood pressure | Through study completion, estimated 18 months | 
| Number of participants with eclampsia | new onset of seizures in pregnant woman with preeclampsia | Anytime during pregnancy and 3 months post partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with placental abruption | Separation of placenta from the uterus prior to delivery | Through study completion, estimated 18 months | 
| Number of participants with post partum hemorrhage | blood loss after delivery | Through study completion, estimated 18 months | 
| Number of participants with aplastic anemia | deficiency of all blood cell lines | Through study completion, estimated 18 months | 
| Number of participants with agranulocytosis | deficiency of granulocytes | Through study completion, estimated 18 months | 
| Number of participants with anaphylaxis | serious allergic reaction | Through study completion, estimated 18 months |