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OpenTrials
Completed

NCT Number: NCT03961360

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

  • 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

Treatment and study plan

Aspirin 81 mg

Drug

Low dose aspirin was initially reported as having a beneficial effect at preeclampsia

Aspirin 162 mg

Drug

Low dose aspirin was initially reported as having a beneficial effect at preeclampsia

Primary outcomes

  1. Number of Participants With Preeclampsia Diagnosis With Severe Features Based on Clinician Diagnosis

    Time frame: 3-7 months

    based on American College Obstetrics and Gynecology (ACOG) guidelines

Secondary outcomes

  1. Maternal Outcomes- Number of Participants Who Delivered Due to Preeclampsia With Severe Features

    Time frame: less than 37 weeks gestational age (GA)

  2. Maternal Outcomes-Number of Participants With Gestational Hypertension

    Time frame: 3-7 months

    development of hypertension anytime during pregnancy based on ACOG guidelines

  3. Maternal Outcomes- Number of Participants With 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- Number of Participants With Eclampsia

    Time frame: 20 weeks

    onset of seizures (convulsions) in a woman with pre-eclampsia per ACOG guidelines

  5. Maternal Outcomes- Number of Participants With 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- Number of Participants With Postpartum Hemorrhage

    Time frame: 1-24 hrs post delivery

    excessive bleeding following the birth of a baby

  7. Maternal Outcomes- Number of Participants With Other Maternal Bleeding

    Time frame: during labor to 24 hrs post delivery

    any other bleeding associated with birth not otherwise categorized

  8. Maternal Outcomes- Number of Participants That Required Blood Transfusion

    Time frame: during delivery

    peripartum

  9. Neonatal Outcome- Gestational Age at Delivery

    Time frame: at delivery

  10. Neonatal Outcomes-Delivery at < 37 Weeks

    Time frame: at delivery

  11. Neonatal Outcomes-Apgar Score < 5 at 5 Minutes

    Time frame: 5 minutes post delivery

    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.

  12. Neonatal Outcome-Small for Gestational Age

    Time frame: at delivery

    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.

  13. Neonatal Outcome-Neonatal Intensive Care Unit (NICU) Length of Stay

    Time frame: from birth until discharge from NICU (about 1 to 4 weeks)

  14. Neonatal Outcome- Number of Participants With Intraventricular Hemorrhage Grade III-IV

    Time frame: from birth until discharge from NICU (about 1 to 4 weeks)

    bleeding inside or around the ventricles in the brain.

  15. Neonatal Outcome-Number of Participants With Bronchopulmonary Dysplasia

    Time frame: from birth until discharge from NICU (about 1 to 4 weeks)

    chronic lung disease that affects newborns (mostly premature) and infants.

  16. Neonatal Outcome-Number of Participants With Necrotizing Enterocolitis

    Time frame: from birth until discharge from NICU (about 1 to 4 weeks)

    medical condition where a portion of the bowel dies

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study 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)

Acronym: ASPREO

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 23, 2019
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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