Role of ASpirin in Placental and Maternal Endothelial Cell Regulation IN Pre-eclampsia
Purpose
Endothelial dysfunction and defective placental vascularization are hypothesized to be significant causes of preeclampsia. In preeclampsia, due to vascular endothelial dysfunction, vasoconstriction and platelet activation can result in severe features which alter pregnancy outcomes. However, studies have shown that acetylsalicylic acid (Aspirin) can decrease endothelial dysfunction leading to decreased platelet aggregation which reduces adverse outcomes. The objective of our study is to determine if Aspirin has a dose-dependent response for modifying biomarkers reflective of maternal endothelial dysfunction when indicated for preeclampsia prevention in a cohort of women identified at risk for developing preeclampsia. Pregnant women who are at risk for preeclampsia will be randomized to receive either 81mg Aspirin or 162mg Aspirin daily starting from 11-16 weeks of gestation until 36 weeks of gestation. A third, control group of women at low risk for preeclampsia will not receive aspirin. All women will be assessed with uterine artery Doppler studies and mean arterial blood pressures at three time points during pregnancy. Blood, urine, and cord blood samples will also be collected.
Condition
- Pre-Eclampsia
Eligibility
- Eligible Ages
- Between 18 Years and 45 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
(control) • No risk factors for preeclampsia Inclusion Criteria (pre-eclampsia) - History of preterm preeclampsia - Chronic hypertension - Type 1 and Type 2 diabetes - Renal diseases - Autoimmune disease
Exclusion Criteria
- Pregnant women younger than 18 years or older than 45 years - Multiple gestations - History of allergy (urticaria or anaphylaxis) to aspirin or aspirin-related products asthma that worsens after aspirin use - Patients with gastrointestinal or genitourinary bleeding - Patients with peptic ulcer disease - Patients with severe liver dysfunction - Patients who have undergone bypass surgery - Patients on anticoagulant medication(s) - Women with anomalous fetus
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Control Group |
Patients will receive standard of care. |
|
|
Experimental Acetylsalicylic Acid 81mg |
Patients will receive low dose (81mg) acetylsalicylic acid (Aspirin). |
|
|
Experimental Acetylsalicylic Acid 162mg |
Patients will receive low dose (162mg) acetylsalicylic acid (Aspirin). |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
Lexington, Kentucky 40536
More Details
- NCT ID
- NCT03893630
- Status
- Recruiting
- Sponsor
- John O'Brien, MD
Detailed Description
Eligible women will be identified in the late first or early second trimesters. Once recruited, women will be randomly assigned to either 81 mg or 162 mg per day dosing schedules. The randomization scheme will vary based on the body mass index (BMI) with separate schemes for women <=30 kg/m2 versus >30 kg/m2. Ultrasonographic assessment of biophysical biomarkers will be obtained at 11-16 weeks, 18-22 weeks, and 28-32 weeks gestation. Biologic samples of serum and urine will be obtained at the 11-16 week and 28-32 week visit. Upon delivery, cord blood and a placental specimen will also be obtained. Medication treatment will continue until 36 weeks gestation. Pregnancy and neonatal outcome data will be recorded.