RECRUITING

APPLE: Aspirin to Prevent Pregnancy Loss 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 goal of this clinical trial is to investigate the effects of early initiation of double low-dose aspirin in pregnant women. The main questions it aims to answer are: Does this dose and timing of aspirin reduce the risk of pre-eclampsia compared to standard recommendations? Does this dose and timing of aspirin reduce the risk of pregnancy loss compared to standard recommendations? Participants will begin taking at no later than 6 weeks 6 days gestational age, either 162mg of aspirin through delivery or placebo until 12 weeks and then 81mg of aspirin through delivery.

Official Title

APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia

Quick Facts

Study Start:2024-06-12
Study Completion:2029-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06408181

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 to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Kurt T Barnhart, MD
CONTACT
215-662-2974
kbarnhart@pennmedicine.upenn.edu
Enrique Schisterman, PhD
CONTACT
enrique.schisterman@pennmedicine.upenn.edu

Principal Investigator

Enrique Schisterman, PhD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Kurt Barnhart, MD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Enrique Schisterman, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania
  • Kurt Barnhart, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

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 Date2024-06-12
Study Completion Date2029-06

Study Record Updates

Study Start Date2024-06-12
Study Completion Date2029-06

Terms related to this study

Additional Relevant MeSH Terms

  • Pre-Eclampsia
  • Pregnancy Loss