Non-invasive screening for preeclampsia in pregnant women

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 study involves enrolling pregnant women between 11 and 14 weeks of gestation to collect blood samples and relevant medical history for evaluating preeclampsia. The goal is to validate the Labcorp Preeclampsia ScreenTM assay and gather data on pregnancy outcomes. Participants will provide blood samples at each trimester visit and agree to share prenatal and postnatal screening results. The collected data will help in assessing the performance of the assay and developing new testing methods.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subject is female and 18 years of age and older;
* Subject provides a signed and dated informed consent;
* Subject is pregnant with a singleton pregnancy at ≥11.0 - ≤14.0 weeks' gestation;
* Subject agrees to provide the Sponsor access to any prenatal and postnatal screening or diagnostic test results and supporting data;
* Subject agrees to have UtAPI calculated during their SOC first trimester ultrasound and MAP collected at the first trimester SOC visit;
* Subject agrees to provide up to 25mL of whole blood at each trimester visit;
* Subject agrees to provide relevant medical and pregnancy/postnatal information including outcome.

Exclusion Criteria:

* Subject is unlikely to return for second and third trimester testing;
* Subject is unlikely to have pregnancy outcome data available;
* Previous sample donation under this protocol with the same pregnancy;
* Subject is participating in a blinded aspirin study or taking unknown doses of aspirin.

Where it's running

• Valley Perinatal
  Glendale, Arizona, United States Recruiting
• Delaware Center for Maternal and Fetal Medicine
  Newark, Delaware, United States Recruiting
• Southern Clinical Research Associates
  Metairie, Louisiana, United States Recruiting
• New Jersey Perinatal Associates
  Livingston, New Jersey, United States Recruiting
• Rutgers Robert Wood Johnson Medical School
  New Brunswick, New Jersey, United States Recruiting
• Capital Health
  Pennington, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Emily Rosenfeld, DO — Rutgers Robert Wood Johnson Medical School
• Study coordinator: Graham McLennan, MS
• Email: mclenng@labcorp.com
• Phone: (858) 202-9162

Similar studies

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

• Preeclampsia and normal pregnancy: retinal microcirculation using OCTA

  This study tests retinal blood flow in pregnant people with preeclampsia compared to healthy pregnant people using OCTA imaging.

  Recruiting Muğla Sıtkı Koçman University · Muğla, Menteşe · NCT07874191

• Maternal insulin and fat metabolism in pregnancies at risk for preeclampsia and gestational diabetes

  This project will try to see if insulin resistance and how the body burns fats early in pregnancy predict later preeclampsia or gestational diabetes in people at higher risk.

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• Origins, features, and effects of preeclampsia on mother and baby

  This project will follow pregnant women diagnosed with preeclampsia through late pregnancy, delivery, and early postpartum to collect clinical data and biological samples to see how preeclampsia affects mothers and their babies.

  Recruiting Medical University of Graz · Graz · NCT07513558

• National first-trimester screening program to prevent preeclampsia in Denmark

  This program will try a new first-trimester screening for pregnant women with a single pregnancy in Denmark to find those at high risk of preeclampsia and offer early prevention such as low-dose aspirin.

  Recruiting at 3 sites Copenhagen University Hospital at Herlev · Aarhus and 2 other locations · NCT07485140

• Blood protein markers and heart changes in pregnant women with preeclampsia

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• Heart risk check for young women 3–6 years after pregnancy with or without placental complications.

  This project will test an app-based algorithm to see if it can identify cardiovascular risk in women 3–6 years after giving birth, including those who had preeclampsia or low-birth-weight infants.

  Recruiting Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Barcelona · NCT07356817

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.