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: Completed
• 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 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

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
Number of Participants With Preeclampsia Diagnosis With Severe Features Based on Clinician Diagnosis	based on American College Obstetrics and Gynecology (ACOG) guidelines	3-7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Outcomes- Number of Participants Who Delivered Due to Preeclampsia With Severe Features		less than 37 weeks gestational age (GA)
Maternal Outcomes-Number of Participants With Gestational Hypertension	development of hypertension anytime during pregnancy based on ACOG guidelines	3-7 months
Maternal Outcomes- Number of Participants With 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- Number of Participants With Eclampsia	onset of seizures (convulsions) in a woman with pre-eclampsia per ACOG guidelines	20 weeks
Maternal Outcomes- Number of Participants With 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- Number of Participants With Postpartum Hemorrhage	excessive bleeding following the birth of a baby	1-24 hrs post delivery
Maternal Outcomes- Number of Participants With Other Maternal Bleeding	any other bleeding associated with birth not otherwise categorized	during labor to 24 hrs post delivery
Maternal Outcomes- Number of Participants That Required Blood Transfusion	peripartum	during delivery
Neonatal Outcome- Gestational Age at Delivery		at delivery
Neonatal Outcomes-Delivery at < 37 Weeks		at delivery
Neonatal Outcomes-Apgar Score < 5 at 5 Minutes	The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome.	5 minutes post delivery
Neonatal Outcome-Small for Gestational Age	Small for gestational age (SGA) means that a fetus or an infant is smaller or less developed than normal for the baby's sex and gestational age. Small for gestational age (SGA) is defined as a birth weight that is below the 10th percentile.	at delivery
Neonatal Outcome-Neonatal Intensive Care Unit (NICU) Length of Stay		from birth until discharge from NICU (about 1 to 4 weeks)
Neonatal Outcome- Number of Participants With Intraventricular Hemorrhage Grade III-IV	bleeding inside or around the ventricles in the brain.	from birth until discharge from NICU (about 1 to 4 weeks)
Neonatal Outcome-Number of Participants With Bronchopulmonary Dysplasia	chronic lung disease that affects newborns (mostly premature) and infants.	from birth until discharge from NICU (about 1 to 4 weeks)
Neonatal Outcome-Number of Participants With Necrotizing Enterocolitis	medical condition where a portion of the bowel dies	from birth until discharge from NICU (about 1 to 4 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 (Actual): April 10, 2023
• Study Completion (Actual): April 10, 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): May 8, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Hypertension; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; 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