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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Pre-Eclampsia; Hypertension in Pregnancy
• Intervention / Treatment: Drug: Aspirin 162 mg; Drug: Aspirin 81 mg

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Farah Amro, MD; Phone Number: 713-500-6421; Email: farah.h.amro@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: farah Amro, MD, University of Texas Health Science Center of Houston

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2019
• Primary Completion (Anticipated): April 28, 2023
• Study Completion (Anticipated): April 28, 2023

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Hypertension; Eclampsia; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: HSC-MS-18-1073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No