RECRUITING

Postpartum Low-Dose Aspirin and Preeclampsia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-07-22
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03667326

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Singleton or Multiple gestation
  2. * Maternal age \>= 18 years
  3. * 20 0/7 weeks gestation or greater
  4. * Severe Preeclampsia diagnosed prior to delivery
  1. * Aspirin use postpartum for other medical indication
  2. * Lovenox, unfractionated heparin, or other anticoagulant use postpartum for an indication other than postoperative (in-house)
  3. * Aspirin use within 7 days of planned initial FMD testing postpartum
  4. * Hypersensitivity or allergy to Aspirin or other salicylates
  5. * Hypersensitivity or allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) - exception if taking LDA in pregnancy
  6. * Nasal polyps
  7. * Gastric or Duodenal ulcers, history of GI bleeding
  8. * Severe hepatic dysfunction
  9. * Bleeding disorders and diathesis
  10. * Breastfeeding a newborn with low platelets (NAIT)

Contacts and Locations

Study Contact

Aleha Aziz, MD, MPH
CONTACT
646-678-0289
aa4065@cumc.columbia.edu
Natalie Bello, MD, MPH
CONTACT
212-305-1436
nb338@cumc.columbia.edu

Principal Investigator

Aleha Aziz, MD, MPH
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University Irving Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Aleha Aziz, MD, MPH, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-07-22
Study Completion Date2025-12

Study Record Updates

Study Start Date2019-07-22
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Aspirin

Additional Relevant MeSH Terms

  • Preeclampsia Postpartum