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

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ClinicalTrials.gov Identifier: NCT03961360
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Farah Hassan Amro, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Pre-Eclampsia Hypertension in Pregnancy Obesity Drug: Aspirin 81 mg Drug: Aspirin 162 mg Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 6, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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




Primary Outcome Measures :
  1. Preeclampsia diagnosis [ Time Frame: 3-7 months ]
    based on American College Obstetrics and Gynecology (ACOG) guidelines


Secondary Outcome Measures :
  1. Maternal Outcomes-Incidence of preterm preeclampsia [ Time Frame: less than 37 weeks gestational age (GA) ]
  2. Maternal Outcomes-Gestational Hypertension [ Time Frame: 3-7 months ]
    development of hypertension anytime during pregnancy based on ACOG guidelines

  3. Maternal Outcomes-Placenta Abruption [ Time Frame: 1 day ]
    Placental abruption occurs when the placenta separates from the inner wall of the uterus before birth. As assessed by treating OBGYN

  4. Maternal Outcomes-Eclampsia [ Time Frame: 20 weeks ]
    onset of seizures (convulsions) in a woman with pre-eclampsia per ACOG guidelines

  5. Maternal Outcomes-HELLP syndrome [ Time Frame: 4 weeks ]
    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

  6. Maternal Outcomes-Postpartum Hemorrhage [ Time Frame: 1-24 hrs post delivery ]
    excessive bleeding following the birth of a baby

  7. Maternal Outcomes-Other maternal bleeding [ Time Frame: during labor to 24 hrs post delivery ]
    any other bleeding associated with birth not otherwise categorized

  8. Maternal Outcomes-Need for blood transfusion [ Time Frame: during delivery ]
    peripartum

  9. Neonatal Outcomes- Gestational age at delivery [ Time Frame: at delivery ]
  10. Neonatal Outcomes-Delivery at < 37 weeks [ Time Frame: at delivery ]
  11. Neonatal Outcomes-Apgar score at 5 min ≤ 5 [ Time Frame: 5 min post delivery ]
    A method to quickly summarize the health of newborn children against infant mortality Appearance, Pulse, Grimace, Activity, and Respiration. Scored from 0-10

  12. Neonatal Outcomes-Small for gestational age [ Time Frame: at delivery ]
  13. Neonatal Outcomes-Neonatal Intensive Care Unit (NICU) length of stay [ Time Frame: from birth until discharge from NICU (about 1 to 10 weeks) ]
  14. Neonatal Outcomes-Intraventricular Hemorrhage Grade III-IV [ Time Frame: from birth until discharge from NICU (about 1 to 10 weeks) ]
    bleeding inside or around the ventricles in the brain.

  15. Neonatal Outcomes-Bronchopulmonary Dysplasia [ Time Frame: from birth until discharge from NICU (about 1 to 10 weeks) ]
    chronic lung disease that affects newborns (mostly premature) and infants.

  16. Neonatal Outcomes-Necrotizing Enterocolitis [ Time Frame: from birth until discharge from NICU (about 1 to 10 weeks) ]
    medical condition where a portion of the bowel dies



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961360


Contacts
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Contact: Farah Amro, MD 713-500-6421 farah.h.amro@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Farah H Amro, MD    713-500-6421    farah.h.amro@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: farah Amro, MD University of Texas Health Science Center of Houston

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Responsible Party: Farah Hassan Amro, Clinical Fellow OBGYN, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03961360     History of Changes
Other Study ID Numbers: HSC-MS-18-1073
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Hypertension
Vascular Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics