RECRUITING

EV Based Platform for Monitoring Therapeutics Response During Pregnancy (ARISE)

Conditions

Preeclampsia Extracellular vesicles proteome profile Aspirin treatment Pregnancy

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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 prospective observational cohort study of pregnant people at-risk of preeclampsia receiving aspirin as part of clinical care or a planned randomized controlled trial of 81mg vs. 162mg of aspirin is to generate proteomic data to show a distinct maternal and fetal Extracellular Vesicle (EV) proteome profile with aspirin treatment, and develop and validate a multi-marker panel for the monitoring of placental function in people at-risk of Preeclampsia and in response to aspirin treatment. The primary research question is: 1\. Does the maternal and fetal Positive for Placental Alkaline Phosphatase (PLAP+) Extracellular Vesicle (EV) proteome profile in the 2nd and 3rd trimester of pregnancy differ between people who receive aspirin and develop (or not) preeclampsia? Participants will be asked to give blood samples up to four times during and at the end of their pregnancy.

Official Title

Developing Extracellular Vesicle Based MPRINT Translational Resource Platform for Monitoring Therapeutics Response During Pregnancy

Quick Facts

Study Start:2024-07-02

Study Completion:2028-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06249178

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:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	1. age \< 18 years, 2. involuntarily confined or detained 3. considered as having a diminished decision-making capacity 4. multifetal gestation 5. pregestational diabetes mellitus or gestational diabetes diagnosed \< 20 weeks due to the impact on exosome response 6. known or suspected fetal aneuploidy or major congenital abnormality, fetal demise, or planned pregnancy termination 7. known allergy or hypersensitivity to aspirin or any medical condition where aspirin is contraindicated (e.g., peptic ulcer disease, nasal polyps, NSAID-induced asthma, gastrointestinal bleeding, G6PD deficiency, severe hepatic dysfunction, bleeding disorders) 8. plan to deliver at another center or participating in another intervention study that influences the primary outcome in this study, without prior approval

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

1. age \< 18 years,
2. involuntarily confined or detained
3. considered as having a diminished decision-making capacity
4. multifetal gestation
5. pregestational diabetes mellitus or gestational diabetes diagnosed \< 20 weeks due to the impact on exosome response
6. known or suspected fetal aneuploidy or major congenital abnormality, fetal demise, or planned pregnancy termination
7. known allergy or hypersensitivity to aspirin or any medical condition where aspirin is contraindicated (e.g., peptic ulcer disease, nasal polyps, NSAID-induced asthma, gastrointestinal bleeding, G6PD deficiency, severe hepatic dysfunction, bleeding disorders)
8. plan to deliver at another center or participating in another intervention study that influences the primary outcome in this study, without prior approval

Contacts and Locations

Study Contact

Maged Costantine, MD, MBA

CONTACT

614-293-2222

Maged.Costantine@osumc.edu

Kara Rood, MD

CONTACT

614-293-8045

Kara.Rood@osumc.edu

Principal Investigator

Maged Costantine, MD, MBA

PRINCIPAL_INVESTIGATOR

Ohio State University

Study Locations (Sites)

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Ohio State University

Maged Costantine, MD, MBA, PRINCIPAL_INVESTIGATOR, Ohio State 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 Date2024-07-02

Study Completion Date2028-09-01

Study Record Updates

Study Start Date2024-07-02

Study Completion Date2028-09-01

Terms related to this study

Keywords Provided by Researchers

Extracellular vesicles proteome profile
Aspirin treatment
Pregnancy
Preeclampsia

Additional Relevant MeSH Terms

Preeclampsia