New York, New York 10032


Purpose:

The purpose of this research study is to find out whether women with preeclampsia taking low-dose aspirin (LDA) for 6 weeks post-delivery will experience an improvement in endothelial function (measured as flow-mediated dilation - FMD) and severity of disease, as the effects of preeclampsia can persist postpartum. Women diagnosed with preeclampsia prior to delivery will be enrolled and randomized to receive either low-dose aspirin (81mg) or placebo to take daily for up to 6 weeks post-delivery.


Study summary:

Preeclampsia is a serious disease of pregnancy that manifests with increased blood pressure and can affect all the organs in a woman's body. It usually develops after 20 weeks of pregnancy. There is an abnormal amount of protein in the urine and with worsening disease known as "severe features," patients can have pain in the upper abdomen, changes in vision, fluid in the lungs, an intense headache, low number of platelets in the blood, and abnormal liver or kidney function. Very high blood pressure is also considered a severe feature. The exact cause of preeclampsia is unknown but women with the condition are at increased risk for complications during pregnancy, including seizures - eclampsia. Babies are at risk of being born premature because the only cure for preeclampsia is delivery. Women who have had preeclampsia are also at increased risk of cardiovascular and kidney disease later in life, including heart attack, stroke and high blood pressure.Studies show that women at high risk for preeclampsia, ie. have had preeclampsia in a prior pregnancy, are carrying more than one fetus, have a history of high blood pressure, kidney disease or both, have certain medical problems such as diabetes, thrombophilia or lupus, have a modestly decreased risk of disease with daily intake of low-dose aspirin starting after 12 weeks of pregnancy. Due to the limited data available on the topic of LDA in preeclamptic patients in the postpartum period, particularly as applicable to the American population, the investigator intends to start with a small pilot study involving the collection of information on 10 women not exposed to study intervention. This will allow for confirmation of the sample size based on the baseline FMD measurements 2 days after delivery.


Criteria:

Inclusion Criteria: - Singleton gestation - Maternal age >= 18 years - 20 0/7 to 40 6/7 weeks gestation - Preeclampsia diagnosed prior to delivery Exclusion Criteria: - Multiple gestation - Aspirin use postpartum for other medical indication - Hypersensitivity or allergy to Aspirin or other salicylates - Hypersensitivity or allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) - Nasal polyps - Gastric or Duodenal ulcers, history of GI bleeding - Renal or severe hepatic dysfunction - Bleeding diathesis - Breastfeeding a newborn with low platelets (NAIT) - Patients enrolled in the Pravastatin and Chronic Hypertension and Pregnancy (CHAP) studies


NCT ID:

NCT03667326


Primary Contact:

Principal Investigator
Kirsten Cleary, MD
Assistant Professor of Obstetrics and Gynecology at the Columbia

Kirsten Cleary, MD
Phone: 212-305-6293
Email: klc2108@cumc.columbia.edu


Backup Contact:

Email: aa4065@cumc.columbia.edu
Aleha Aziz, MD, MPH
Phone: 646-678-0289


Location Contact:

New York, New York 10032
United States

Aleha Aziz, MD
Phone: 646-678-0289
Email: aa4065@cumc.columbia.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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