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Pre-EclampsiaPhase 2/3ASPREONCT03961360

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

A Phase 2/3 study testing Aspirin 81 mg and Aspirin 162 mg in people with Pre-Eclampsia and Hypertension in Pregnancy, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Pre-Eclampsia, Hypertension in Pregnancy, Obesity
What is being tested?
Aspirin 81 mg and Aspirin 162 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
1 siteUnited States
Study dates
6 May 2019to 10 Apr 2023
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • HIV positive status
  • Known major fetal anomalies
  • Multifetal gestation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

Other trials in United States

About this study

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)

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.

Being tested
Aspirin 81 mg, Aspirin 162 mg
Medical subject headings
Pre-Eclampsia, Hypertension, Pregnancy-Induced, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aspirin 81 mgDrug

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

  • Aspirin 162 mgDrug

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

Study groups in NCT03961360
Study groupRoleWhat they receive
162 mg/day AspirinExperimentalNot described
Receives: Drug: Aspirin 162 mg
81 mg/day AspirinActive comparatorNot described
Receives: Drug: Aspirin 81 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    based on American College Obstetrics and Gynecology (ACOG) guidelines

    Measured: 3-7 months

Secondary outcomes (16)

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

    Measured: less than 37 weeks gestational age (GA)

  2. Maternal Outcomes-Number of Participants With Gestational Hypertension

    development of hypertension anytime during pregnancy based on ACOG guidelines

    Measured: 3-7 months

  3. 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

    Measured: 1 day

  4. Maternal Outcomes- Number of Participants With Eclampsia

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

    Measured: 20 weeks

  5. 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

    Measured: 4 weeks

  6. Maternal Outcomes- Number of Participants With Postpartum Hemorrhage

    excessive bleeding following the birth of a baby

    Measured: 1-24 hrs post delivery

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

    any other bleeding associated with birth not otherwise categorized

    Measured: during labor to 24 hrs post delivery

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

    peripartum

    Measured: during delivery

  9. Neonatal Outcome- Gestational Age at Delivery

    Measured: at delivery

  10. Neonatal Outcomes-Delivery at < 37 Weeks

    Measured: at delivery

  11. 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.

    Measured: 5 minutes post delivery

  12. 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.

    Measured: at delivery

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

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

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

    bleeding inside or around the ventricles in the brain.

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

  15. Neonatal Outcome-Number of Participants With Bronchopulmonary Dysplasia

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

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

  16. Neonatal Outcome-Number of Participants With Necrotizing Enterocolitis

    medical condition where a portion of the bowel dies

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2019
  2. Study start6 May 2019
  3. Primary completion10 Apr 2023
  4. Study completion10 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03961360
Sponsor's protocol ID
HSC-MS-18-1073
Acronym
ASPREO
Status last verified
Apr 2024
First submitted
16 Apr 2019
Last updated
8 May 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Aspirin 81 mg and Aspirin 162 mg in people with Pre-Eclampsia and Hypertension in Pregnancy, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Preeclampsia Diagnosis With Severe Features Based on Clinician Diagnosis (time frame: 3-7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03961360.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.

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