Monitoring therapeutic response during pregnancy for preeclampsia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study aims to analyze the extracellular vesicle (EV) proteome profiles of pregnant individuals at risk for preeclampsia who are receiving aspirin treatment. Participants will provide blood samples up to four times during their pregnancy to generate proteomic data that could help identify distinct maternal and fetal EV profiles associated with aspirin use. The study seeks to develop and validate a multi-marker panel to monitor placental function and assess the effectiveness of aspirin in preventing preeclampsia. By focusing on placental-specific biomarkers, the research addresses the gap in therapeutic evaluations for pregnant individuals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants will be eligible to participate if they meet the following study inclusion criteria:

1. pregnant individuals age ≥18 years
2. enrolled ≤16 6/7 weeks of gestation based on the best obstetric estimate as defined by ACOG criteria
3. singleton live intrauterine gestation
4. Any of the following:

   1. 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
   2. 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)
   3. or participating in another clinical RCT of 81mg vs. 162mg aspirin for prevention of hypertensive disorders of pregnancy

Exclusion Criteria:

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

Where it's running

• The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Maged Costantine, MD, MBA — Ohio State University
• Study coordinator: Maged Costantine, MD, MBA
• Email: Maged.Costantine@osumc.edu
• Phone: 614-293-2222

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predicting Adverse Pregnancy Outcomes in Uganda through Partnerships and Innovation

  This study tests whether everyday health data, ultrasound, and blood samples from first-time pregnant women in Uganda can help predict problems like preeclampsia, fetal growth restriction, and preterm birth.

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• Internal jugular vein collapsibility to gauge volume status in preeclampsia vs. normal pregnancy

  This study tests whether ultrasound of the internal jugular vein can show differences in fluid status between preeclamptic pregnant people and those with normal blood pressure during planned cesarean delivery.

  Recruiting Tanta University · Tanta, El-Gharbia Govenorate · NCT07786246

• Higher vs lower daily aspirin in high-risk pregnant people

  This study tests whether taking 150 mg of aspirin daily is more effective than 75 mg daily in preventing preeclampsia among pregnant people at high risk.

  Recruiting Phase 4 Medicare Hospital (Pvt) Limited · Multan, Punjab Province · NCT07779057

• Community health worker support to lower blood pressure after pregnancy with high blood pressure

  Postpartum patients with high blood pressure after pregnancy will try a program where a trained community health worker helps them monitor blood pressure and manage care for 6 months to see if it lowers blood pressure compared with usual care.

  Recruiting University of Alabama at Birmingham · Birmingham, Alabama · NCT07778966

• Role of Progesterone Membrane Receptors in Preeclampsia

  This study looks at whether the levels of progesterone membrane receptors in the placenta differ between women with preeclampsia and healthy pregnant women to understand the condition better.

  Recruiting Samsun University · Samsun · NCT07745036

• Endothelial Biomarkers in Pregnancy: Endothelial Extracellular Vesicles and Hypertensive Disorders

  This study tests whether endothelial extracellular vesicles in the blood differ between normotensive pregnant women and those with hypertensive disorders of pregnancy.

  Recruiting Josip Juraj Strossmayer University of Osijek · Osijek · NCT07728656

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.