Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida (ASPREO)
Primary Purpose
Pre-Eclampsia, Hypertension in Pregnancy, Obesity
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aspirin 81 mg
Aspirin 162 mg
Sponsored by
About this trial
This is an interventional treatment trial for Pre-Eclampsia
Eligibility Criteria
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
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
162 mg/day Aspirin
81 mg/day Aspirin
Arm Description
Outcomes
Primary Outcome Measures
Preeclampsia diagnosis
based on American College Obstetrics and Gynecology (ACOG) guidelines
Secondary Outcome Measures
Maternal Outcomes-Incidence of preterm preeclampsia
Maternal Outcomes-Gestational Hypertension
development of hypertension anytime during pregnancy based on ACOG guidelines
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
Maternal Outcomes-Eclampsia
onset of seizures (convulsions) in a woman with pre-eclampsia per ACOG guidelines
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
Maternal Outcomes-Postpartum Hemorrhage
excessive bleeding following the birth of a baby
Maternal Outcomes-Other maternal bleeding
any other bleeding associated with birth not otherwise categorized
Maternal Outcomes-Need for blood transfusion
peripartum
Neonatal Outcomes- Gestational age at delivery
Neonatal Outcomes-Delivery at < 37 weeks
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
Neonatal Outcomes-Small for gestational age
Neonatal Outcomes-Neonatal Intensive Care Unit (NICU) length of stay
Neonatal Outcomes-Intraventricular Hemorrhage Grade III-IV
bleeding inside or around the ventricles in the brain.
Neonatal Outcomes-Bronchopulmonary Dysplasia
chronic lung disease that affects newborns (mostly premature) and infants.
Neonatal Outcomes-Necrotizing Enterocolitis
medical condition where a portion of the bowel dies
Full Information
NCT ID
NCT03961360
First Posted
April 16, 2019
Last Updated
April 4, 2023
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT03961360
Brief Title
Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida
Acronym
ASPREO
Official Title
Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida: An Open Label, Comparative Effectiveness, Randomized Controlled Trial (ASPREO Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 6, 2019 (Actual)
Primary Completion Date
April 28, 2023 (Anticipated)
Study Completion Date
April 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia, Hypertension in Pregnancy, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
162 mg/day Aspirin
Arm Type
Experimental
Arm Title
81 mg/day Aspirin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Aspirin 81 mg
Intervention Description
Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Intervention Type
Drug
Intervention Name(s)
Aspirin 162 mg
Intervention Description
Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Primary Outcome Measure Information:
Title
Preeclampsia diagnosis
Description
based on American College Obstetrics and Gynecology (ACOG) guidelines
Time Frame
3-7 months
Secondary Outcome Measure Information:
Title
Maternal Outcomes-Incidence of preterm preeclampsia
Time Frame
less than 37 weeks gestational age (GA)
Title
Maternal Outcomes-Gestational Hypertension
Description
development of hypertension anytime during pregnancy based on ACOG guidelines
Time Frame
3-7 months
Title
Maternal Outcomes-Placenta Abruption
Description
Placental abruption occurs when the placenta separates from the inner wall of the uterus before birth. As assessed by treating OBGYN
Time Frame
1 day
Title
Maternal Outcomes-Eclampsia
Description
onset of seizures (convulsions) in a woman with pre-eclampsia per ACOG guidelines
Time Frame
20 weeks
Title
Maternal Outcomes-HELLP syndrome
Description
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
Time Frame
4 weeks
Title
Maternal Outcomes-Postpartum Hemorrhage
Description
excessive bleeding following the birth of a baby
Time Frame
1-24 hrs post delivery
Title
Maternal Outcomes-Other maternal bleeding
Description
any other bleeding associated with birth not otherwise categorized
Time Frame
during labor to 24 hrs post delivery
Title
Maternal Outcomes-Need for blood transfusion
Description
peripartum
Time Frame
during delivery
Title
Neonatal Outcomes- Gestational age at delivery
Time Frame
at delivery
Title
Neonatal Outcomes-Delivery at < 37 weeks
Time Frame
at delivery
Title
Neonatal Outcomes-Apgar score at 5 min ≤ 5
Description
A method to quickly summarize the health of newborn children against infant mortality Appearance, Pulse, Grimace, Activity, and Respiration. Scored from 0-10
Time Frame
5 min post delivery
Title
Neonatal Outcomes-Small for gestational age
Time Frame
at delivery
Title
Neonatal Outcomes-Neonatal Intensive Care Unit (NICU) length of stay
Time Frame
from birth until discharge from NICU (about 1 to 10 weeks)
Title
Neonatal Outcomes-Intraventricular Hemorrhage Grade III-IV
Description
bleeding inside or around the ventricles in the brain.
Time Frame
from birth until discharge from NICU (about 1 to 10 weeks)
Title
Neonatal Outcomes-Bronchopulmonary Dysplasia
Description
chronic lung disease that affects newborns (mostly premature) and infants.
Time Frame
from birth until discharge from NICU (about 1 to 10 weeks)
Title
Neonatal Outcomes-Necrotizing Enterocolitis
Description
medical condition where a portion of the bowel dies
Time Frame
from birth until discharge from NICU (about 1 to 10 weeks)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
farah Amro, MD
Organizational Affiliation
University of Texas Health Science Center of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida
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