Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida

Study Overview
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Brief Summary
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To compare the incidence of preeclampsia in obese pregnant women (BMI greater than 30) with a singleton gestation at less than 20 weeks and either a history of preeclampsia in a prior pregnancy or stage I hypertension or pre-gestational diabetes who are randomized to either 81mg/day aspirin or 162mg/day aspirin.

Official Title
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Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida: An Open Label, Comparative Effectiveness, Randomized Controlled Trial (ASPREO Trial)

Conditions
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Pre-Eclampsia, Hypertension in Pregnancy, Obesity

Intervention / Treatment
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* Drug: Aspirin 81 mg
* Drug: Aspirin 162 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria A singleton gestation at less than 20 weeks at time of enrollment, with a BMI greater than or equal to 30 and one of the following: 1. History of preeclampsia in a prior pregnancy Diagnosis will be obtained by review of records, and if unavailable then patient history. Preeclampsia diagnosis may be made in antepartum or postpartum period. OR 2. At least stage I hypertension during pregnancy Stage I hypertension is defined as a systolic blood pressure between 130- 139 mm Hg or diastolic blood pressure between 80-89 mm Hg21 This blood pressure criteria is met regardless of medication usage The patient must have a blood pressure reading ≥ 130-139/80-89 mm Hg at least during 1 clinic visit during the current pregnancy; before or at time of enrollment OR 3. Pre-gestational diabetes Type 1 and Type 2 diabetics are included Gestational diabetes mellitus diagnosed prior to 20 weeks gestational age will also be included Exclusion Criteria Known allergy/prior adverse reaction/any medical condition where aspirin is contraindicated Already on aspirin prior to pregnancy Baseline renal Disease Baseline proteinuria identified at time of enrollment, defined as urine analysis with 3+ protein, or urine protein to creatinine ratio ≥ 0.3 Systemic Lupus Erythematosus Seizure disorder on medications HIV positive status Known major fetal anomalies Multifetal gestation

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 162 mg/day Aspirin<br> | Drug: Aspirin 162 mg<br>* Low dose aspirin was initially reported as having a beneficial effect at preeclampsia<br>|
| Active Comparator: 81 mg/day Aspirin<br> | Drug: Aspirin 81 mg<br>* Low dose aspirin was initially reported as having a beneficial effect at preeclampsia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preeclampsia diagnosis | based on American College Obstetrics and Gynecology (ACOG) guidelines | 3-7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Outcomes-Incidence of preterm preeclampsia |  | less than 37 weeks gestational age (GA) | 
| Maternal Outcomes-Gestational Hypertension | development of hypertension anytime during pregnancy based on ACOG guidelines | 3-7 months | 
| Maternal Outcomes-Placenta Abruption | Placental abruption occurs when the placenta separates from the inner wall of the uterus before birth. As assessed by treating OBGYN | 1 day | 
| Maternal Outcomes-Eclampsia | onset of seizures (convulsions) in a woman with pre-eclampsia per ACOG guidelines | 20 weeks | 
| Maternal Outcomes-HELLP syndrome | group of symptoms that occur in pregnant women who have: hemolysis(H): (the breakdown of red blood cells)elevated liver enzymes (EL). low platelet (LP) count. Assessed by ACOG guidelines and measured in urine and blood samples | 4 weeks | 
| Maternal Outcomes-Postpartum Hemorrhage | excessive bleeding following the birth of a baby | 1-24 hrs post delivery | 
| Maternal Outcomes-Other maternal bleeding | any other bleeding associated with birth not otherwise categorized | during labor to 24 hrs post delivery | 
| Maternal Outcomes-Need for blood transfusion | peripartum | during delivery | 
| Neonatal Outcomes- Gestational age at delivery |  | at delivery | 
| Neonatal Outcomes-Delivery at < 37 weeks |  | at delivery | 
| Neonatal Outcomes-Apgar score at 5 min ≤ 5 | A method to quickly summarize the health of newborn children against infant mortality Appearance, Pulse, Grimace, Activity, and Respiration. Scored from 0-10 | 5 min post delivery | 
| Neonatal Outcomes-Small for gestational age |  | at delivery | 
| Neonatal Outcomes-Neonatal Intensive Care Unit (NICU) length of stay |  | from birth until discharge from NICU (about 1 to 10 weeks) | 
| Neonatal Outcomes-Intraventricular Hemorrhage Grade III-IV | bleeding inside or around the ventricles in the brain. | from birth until discharge from NICU (about 1 to 10 weeks) | 
| Neonatal Outcomes-Bronchopulmonary Dysplasia | chronic lung disease that affects newborns (mostly premature) and infants. | from birth until discharge from NICU (about 1 to 10 weeks) | 
| Neonatal Outcomes-Necrotizing Enterocolitis | medical condition where a portion of the bowel dies | from birth until discharge from NICU (about 1 to 10 weeks) |