Role of ASpirin in Placental and Maternal Endothelial Cell Regulation IN Pre-eclampsia
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 3/30/2019 |
| Start Date: | April 2019 |
| End Date: | June 2021 |
| Contact: | Aarthi Srinivasan, MD, MS |
| Email: | asr224@uky.edu |
| Phone: | 8592180765 |
Role of Aspirin in Maternal Endothelial Dysfunction and Uterine Artery Blood Flow in Women at Risk for Preeclampsia
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.
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.
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 11-13 weeks, 18-22 weeks, and 28-32 weeks
gestation. Biologic samples of serum and urine will be obtained at the same intervals.
Medication treatment will continue until 36 weeks gestation. Pregnancy and neonatal outcome
data will be recorded.
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 11-13 weeks, 18-22 weeks, and 28-32 weeks
gestation. Biologic samples of serum and urine will be obtained at the same intervals.
Medication treatment will continue until 36 weeks gestation. Pregnancy and neonatal outcome
data will be recorded.
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
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