Postpartum Low-Dose Aspirin After Preeclampsia for Optimization of Cardiovascular Risk (PAPVASC) (PAPVASC)
Preeclampsia Severe, Cardiovascular Diseases, Primary Prevention
About this trial
This is an interventional basic science trial for Preeclampsia Severe
Eligibility Criteria
Inclusion Criteria:
Confirmed severe preeclampsia diagnosed prior to delivery
Preeclampsia defined as: Blood pressure > 140/90 AND proteinuria > 300mg/24 hours OR 2+ on repeat dip stick
Severe Preeclampsia defined as the presence of one or more of the following:
i. systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 110 mmHg on 2 occasions at least 4 hours apart
ii. new-onset cerebral or visual disturbance
iii. severe persistent right upper quadrant pain or serum transaminase concentrations ≥ 2 times the upper limit of normal
iv. thrombocytopenia (platelets < 100 x 109/L)
v. renal insufficiency (serum creatinine > 97.2 umol/L)
vi. pulmonary edema
- A singleton gestation
- Gestation between 24+0/7 to 40+6/7 weeks.Exclusion Criteria:
Exclusion Criteria:
- Multiple pregnancy
- Chronic hypertension or other condition requiring the use of BP-lowering medication
- Cardiovascular disorders: Unstable angina pectoris, heart failure, life-threatening arrhythmia, atrial fibrillation, kidney failure
- Known allergy or sensitivity to aspirin used in the study
- Any medical comorbidity that is a contraindication to LD-ASA: Hemophilia or other bleeding disorder, history of GI bleeding, renal failure, severe liver disease, thrombocytopenia, gout, G6PD deficiency
- Recent history of drug/alcohol abuse (< 1 year prior to delivery), or receiving treatment for such
- Nasal polyps
- Hypercholesterolemia requiring pharmaceutical treatment
- Raynaud's phenomenon
- Collagen-vascular disease: lupus, scleroderma, rheumatoid arthritis
- History of pre-existing diabetes
- Ongoing use of any of the following medications: methotrexate, anti-coagulants, thrombolytics, oral hypoglycemics, uricsuric agents, valproic acid, glucocorticosteroids, digoxin
Sites / Locations
- Queen's University Department of Obstetrics and GynecologyRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
PO LD-ASA
PO Placebo
Study participants who are assigned to the oral aspirin arm of the study will receive 81mg oral aspirin. Over-encapsulated 81mg aspirin tablets will be used. Study participants in this arm will take 81mg aspirin daily for 6 months.
A standard placebo pill, the same size, shape and color of the oral aspirin will be used. The placebo pills will be over-encapsulated in the same manner as the aspirin tablets. The placebo will be administered to the participants randomized to placebo group in the same manner the oral aspirin would be administered - they will take the pill daily for 6 months.