Aspirin to Prevent Preeclampsia in Women With Elevated Blood Pressure and Stage 1 Hypertension (ASPPIRE)
Condition: Pre-Eclampsia; Stage 1 Hypertension; Elevated Blood Pressure
MeSH terms: Pre-Eclampsia; Eclampsia; Hypertension
Intervention: Aspirin 81 mg; Placebo
Intervention description: Participants randomized to 81 mg of Aspirin daily; Participants randomized to placebo daily
Intervention MeSH terms: Aspirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Aspirin

Summary:

      To determine if low dose aspirin reduces the incidence of hypertensive disorders of pregnancy
      (gestational hypertension, preeclampsia, eclampsia, and HELLP syndrome) in pregnant women
      with stage 1 hypertension and elevated blood pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Singleton pregnancy

          -  Elevated blood pressure (At least 2 systolic BP 120-129 mm Hg within 1 year
             pre-pregnancy until 20 weeks gestational age on at least 2 separate healthcare
             encounters) or Stage 1 hypertension (At least 2 systolic BP 130-139 and/or diastolic
             BP 80-89 within 1 year pre-pregnancy until 20 weeks gestational age on at least 2
             separate healthcare encounters)

          -  Speaks English or Spanish

          -  Informed and written consent

          -  Confirmed single live intrauterine pregnancy (confirmed by positive cardiac motion by
             transvaginal or transabdominal ultrasound)

        Exclusion Criteria:

          -  Chronic hypertension

          -  Pre-gestational diabetes

          -  Chronic renal disease

             - diagnosis of stage 1 chronic kidney disease or higher and/or GFR <60 mL/min with
             duration at least 3 months and/or history of kidney transplantation and/or undergoing
             peritoneal or hemodialysis

          -  Systemic lupus erythematous

          -  Antiphospholipid antibody syndrome (diagnosis made by having 1 or more clinical
             criteria and 1 or more laboratory criteria)

               -  Clinical criteria: venous thrombosis, arterial thrombosis, obstetric
                  complications (3 or more unexplained consecutive spontaneous abortions <10 weeks
                  gestation, 1 or more unexplained deaths of a morphologically normal fetus after
                  10 weeks gestation, 1 or more premature births before 34 weeks gestation
                  attributable to placental insufficiency, including severe preeclampsia or fetal
                  growth restriction)

               -  Laboratory criteria: lupus anticoagulant, anti-cardiolipin IgG or IgM with titer
                  >99th percentile, anti-beta 2 glycoprotein IgG or IgM with titer >99th
                  percentile. Laboratory result must be positive twice at least 12 weeks apart

          -  Multifetal gestation

          -  20 weeks gestation at time of randomization based on American College of Obstetricians
             and Gynecologists dating criteria. Dating will be based on last menstrual period (LMP)
             if regular, sure LMP is available that agrees with ultrasound dating. Otherwise,
             earliest ultrasound will be used for dating purposes.

          -  Prior history of hypertensive disorder of pregnancy

          -  Current pregnancy with known chromosomal, genetic, major malformations or fetal
             demise, or planned termination of pregnancy

          -  Women with contraindications to taking aspirin (bleeding diathesis such as Von
             Willebrand's disease, peptic ulcer disease, aspirin hypersensitivity, nasal polyps,
             asthma with aspirin-induced bronchospasm, severe liver disease).

          -  Concurrent participation in another study that influences risk of preeclampsia

          -  Women who do not plan to deliver within the YNHH system