Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age14-35
SponsorOhio State University

About this trial

The overall goal of this large, pragmatic, comparative effectiveness trial is to test the hypothesis that among at-risk individuals, 162 mg/day aspirin is superior to 81 mg/day in preventing Hypertensive disorders of pregnancy (HDP), and that there are multiple factors associated with adherence with aspirin therapy that will be important to identify to enable optimal implementation of study findings and population-level benefits.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

live intrauterine gestation ≤16 6/7 weeks gestational age based on best clinical obstetric estimate,

age 14 years or older and able to provide informed consent,

at least one of the following high-risk criteria: i) any prior pregnancy complicated by preeclampsia ii) current pregnancy complicated by chronic hypertension diagnosed before randomization (ACOG) iii) pre-gestational diabetes (on medication for diabetes prior to pregnancy, or diabetes is diagnosed prior to randomization with hemoglobin A1C of 6.5% or greater or abnormal 3-hour glucose tolerance test) iv) twin gestation (including higher order pregnancy reduced to twins prior to 14 weeks) v) chronic kidney disease vi) autoimmune disease (e.g., antiphospholipid syndrome, systemic lupus erythematous)

or two or more moderate-risk criteria for HDP (per USPSTF), i) nulliparity (no prior delivery at or after 20 weeks 0 days of gestation) ii) obesity (body mass index ≥30 kg/m2 at time of randomization) iii) age ≥35 years (at time of expected estimated due date) iv) Black race v) low income vi) personal risk factors (previous pregnancy with low birth weight or SGA infant, previous adverse pregnancy outcome [unexplained stillbirth], placental abruption, interval >10 years between pregnancies) vii) Family history of preeclampsia (i.e., mother or sister) viii) In vitro fertilization

Disqualifiers

known allergy or hypersensitivity to aspirin or any medical condition where aspirin is contraindicated (e.g., active peptic ulcer disease, nasal polyps, NSAID-induced asthma, active gastrointestinal bleeding, known G6PD deficiency, severe hepatic dysfunction, bleeding disorders, history of bariatric surgery),

current or planned aspirin use in pregnancy for non-obstetrical indication (e.g., prior stroke/prior myocardial infraction),

age < 14 years,

involuntarily confined or detained,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aspirin 81 mg

    Drug

    Participants will be assigned to 81mg Aspirin

  • Aspirin 162 mg

    Drug

    Participants will be assigned to 162mg Aspirin

Treatment groups

10,742 Participants
are divided into 2 treatment groups
Group A: 81 mg AspirinExperimental treatment 1 intervention
Group B: 162 mg AspirinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Hypertensive Disorder of Pregnancy (HDP)

HDP defined as preeclampsia or antepartum gHTN based on ACOG criteria

Time frame
From >20 weeks gestation until hospital discharge following delivery, up to 22 weeks

Secondary outcomes

1

Preeclampsia

preeclampsia based on ACOG criteria

Time frame
From >20 weeks gestation until hospital discharge following delivery, up to 22 weeks
2

Preterm preeclampsia

Preeclampsia per ACOG criteria with delivery \< 37 weeks'

Time frame
From >20 weeks and ≤ 36 weeks 6 days, up to 17 weeks
3

Postpartum preeclampsia

Postpartum preeclampsia per ACOG criteria

Time frame
From delivery weeks till 6 weeks postpartum; 6 weeks
4

Gestational hypertension

Gestational hypertension per ACOG criteria

Time frame
From >20 weeks until onset of labor, up to 22 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Northwestern University

Collaborator

Preeclampsia Foundation

Collaborator