Low-Dose Aspirin in the Postpartum Period and Endothelial Function in Patients With Preeclampsia

Who is this study for? Patients with preeclampsia
What treatments are being studied? Aspirin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this research study is to find out whether women with severe preeclampsia taking low-dose aspirin (LDA) for 3 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 severe preeclampsia prior to delivery will be enrolled and randomized to receive either low-dose aspirin (81mg) or placebo to take daily for up to 3 weeks post-delivery. Exploratory objective includes healthy control postpartum patients without preeclampsia and not on LDA during pregnancy or postpartum in comparison with the primary study population affected by preeclampsia with severe features.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• Singleton or Multiple gestation

• Maternal age \>= 18 years

• 20 0/7 weeks gestation or greater

• Severe Preeclampsia diagnosed prior to delivery

Locations
United States
New York
Columbia University Irving Medical Center
RECRUITING
New York
Contact Information
Primary
Aleha Aziz, MD, MPH
aa4065@cumc.columbia.edu
646-678-0289
Backup
Natalie Bello, MD, MPH
nb338@cumc.columbia.edu
212-305-1436
Time Frame
Start Date: 2019-07-22
Estimated Completion Date: 2025-12
Participants
Target number of participants: 100
Treatments
Active_comparator: Low-Dose Aspirin (LDA) Intervention Group
Subjects diagnosed with severe preeclampsia prior to delivery (antepartum or intrapartum) will take 81mg of aspirin daily for up to 3 weeks postpartum, starting within 4 days after delivery.
Placebo_comparator: Placebo Control Group
Subjects diagnosed with severe preeclampsia prior to delivery (antepartum or intrapartum) will take placebo oral capsule daily for up to 3 weeks postpartum, starting within 4 days after delivery.
No_intervention: Healthy Controls Group
Subjects who are healthy volunteers (n = 10) without severe preeclampsia prior to delivery.
Authors
Kirsten Cleary, Natalie Bello
Related Therapeutic Areas
Sponsors
Leads: Columbia University

This content was sourced from clinicaltrials.gov