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

NCT06249178 | Recruiting

• 2 other identifiers: 2024H00501R24HD113024
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preeclampsia

Keywords

Extracellular vesicles proteome profile; Aspirin treatment; Pregnancy; Preeclampsia

Outcome Measures

Primary Outcomes (1)

• multi-marker panel

  Multi-marker panel (list of proteins) associated with placental function in people at-risk of PE and in response to aspirin treatment.

  From enrollment till delivery; up to 29 weeks

Secondary Outcomes (9)

• Preeclampsia

  From enrollment to deliver; up to 29 weeks

• Preterm birth < 37 weeks gestation

  From enrollment to deliver; up to 25 weeks

• Preterm birth < 34 weeks gestation

  From enrollment to deliver; up to 22 weeks

• Preeclampsia with severe features

  From enrollment to deliver; up to 29 weeks

• Gestational hypertension

  From enrollment to deliver, up to 29 weeks

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women greater than 18 years of age at risk of preeclampsia (PE), receiving aspirin to prevent PE or a candidate to receive aspirin.

You may qualify if:

• pregnant individuals age ≥18 years
• enrolled ≤16 6/7 weeks of gestation based on the best obstetric estimate as defined by ACOG criteria
• singleton live intrauterine gestation
• Any of the following:
• At least one of the high-risk criteria for HDP (per US Preventive Services Task Force Recommendation Statement \[USPSTF\]); i) any prior pregnancy complicated by Preeclampsia ii) current pregnancy complicated by chronic hypertension iii) chronic kidney disease iv) autoimmune disease (e.g., antiphospholipid syndrome, lupus) or
• Two or more moderate-risk criteria for HDP (per USPSTF); i) nulliparity (no prior delivery at or after 20 weeks 0 days of gestation) ii) obesity (body mass index ≥30 kg/m2 at time of enrollment) iii) age ≥35 years (at time of expected estimated due date) iv) Black race v) Low income vi) Personal risk factors (previous pregnancy with low birth weight or SGA infant, previous adverse pregnancy outcome \[unexplained stillbirth\], placental abruption, interval \>10 years between pregnancies).
• vii) Pregnancy after in vitro conception viii) family history of preeclampsia ( i.e., mother or sister)
• or participating in another clinical RCT of 81mg vs. 162mg aspirin for prevention of hypertensive disorders of pregnancy

You may not qualify if:

• age \< 18 years,
• involuntarily confined or detained
• considered as having a diminished decision-making capacity
• multifetal gestation
• pregestational diabetes mellitus or gestational diabetes diagnosed \< 20 weeks due to the impact on exosome response
• known or suspected fetal aneuploidy or major congenital abnormality, fetal demise, or planned pregnancy termination
• 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)
• plan to deliver at another center or participating in another intervention study that influences the primary outcome in this study, without prior approval

Sponsors & Collaborators

• University of Texas: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Ohio State University: lead

Study Sites (1)

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

Columbus, Ohio, 43210, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and optional placenta samples will be collected.

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Maged Costantine, MD, MBA

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maged Costantine, MD, MBA

CONTACT

614-293-2222; Maged.Costantine@osumc.edu

Kara Rood, MD

CONTACT

614-293-8045; Kara.Rood@osumc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MBA, Professor

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: July 2, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)