Preeclampsia (PE)NCT06643741
Non-Invasive Preeclampsia Screening and Biobank
An observational study of Preeclampsia (PE), run by Sequenom, Inc. at 21 sites in United States.
Trial summary
Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia (PE)
- How many people
- 6,550 participants
- Where
- 21 sitesUnited States
- Study dates
- 2 Feb 2025to 1 Jul 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subject is pregnant with a singleton pregnancy at ≥11.0 - ≤14.0 weeks' gestation
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
United States21 sites, 20 recruiting
- Recruiting
St. David's Women's Center of Texas
Austin, Texas, 78758
Adrianna Knight, BSN, RN, 512-493-6925, adrianna.knight@stdavids.com
Mollie McDonnold, MD
- Not yet recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Anna Modest, 781-956-5282, ammodest@bidmc.harvard.edu
Cassandra Duffy, MD, MPH
- Not yet recruiting
Cooper University Health Care
Camden, New Jersey, 08103
Ankur Patel, 856-342-2000 ext. 1007032, patel-ankur@cooperhealth.edu
Robin Perry, MD, MSEd
- Recruiting
Chattanooga Medical Research
Chattanooga, Tennessee, 37412
Yvonne Chester, 423-648-7794, ychester@chattmedresearch.com
Scott Harsberger, MD
- Not yet recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Cynthia Drazenovich, 570-271-8667, cdrazenovich1@geisinger.edu
Michael Paglia, MD, PhD
- Recruiting
University of Texas Medical Branch
Galveston, Texas, 77555
Sonia Robazetti, RN, scrobaze@utmb.edu
Hassan Harirah, MD, FRCSC
- Recruiting
Valley Perinatal
Glendale, Arizona, 85304
Tina Rommes, 480-660--4040, amin@valleyperinatal.com
Ravindu Gunatilake, MD
- Recruiting
UT Health
Houston, Texas, 77030
Sunbola S Ashimi, (713) 500-6484, sunbola.s.ashimi@uth.tmc.edu
Baha M Sibai, MD
- Recruiting
HCA Healthcare, Texas Maternal Fetal Medicine
Houston, Texas, 77054
Valencia Moore, BSN, RN, 346-581-4802, valencia.moore@hcahealthcare.com
David Kennedy, 832-237-6301, david.kennedy@hcahealthcare.com
- Recruiting
New Jersey Perinatal Associates
Livingston, New Jersey, 07039
Megha Soni, msoni@njperinatal.com
Kathy Mathews, MD
- Recruiting
Southern Clinical Research Associates
Metairie, Louisiana, 70001
Shaune Braud, RN, 504-810-4414, sbraud@scrallc.com
Samuel Alexander, MD
- Terminated
D&H National Research Centers
Miami, Florida, 33155
- Recruiting
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Emily Rosenfeld, DO, (732) 235-6200, er720@rwjms.rutgers.edu
Emily Rosenfeld, DO
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Casandra Almonte, 646-284-5360, ca2344@cumc.columbia.edu
Eve Overton, MD
- Recruiting
Lenox Hill Hospital
New York, New York, 10075
Tamika Wong, 212-434-4836, twong4@northwell.edu
Eran Bornstein, MD
- Recruiting
Delaware Center for Maternal and Fetal Medicine
Newark, Delaware, 19718
Carrie Kitto, 302-319-5680, ckitto@christianacare.org
Suneet Chauhan, MD, DSc
- Recruiting
Macon & Joan Brock Virginia Health Sciences at Old Dominion University
Norfolk, Virginia, 23507
Caitlyn Mcadams, (757) 446-5653, cmcadams@odu.edu
George Saade, MD
- Recruiting
Capital Health
Pennington, New Jersey, 08534
Saadia Kazmi, 609-3944-130, skazmi@capitalhealth.org
Thomas Westover, MD
- Recruiting
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
Elaina Symes, 267-438-2709, Elaina.symes@pennmedicine.UPenn.edu
Lorraine Dugoff, MD
- Not yet recruiting
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, 19140
Sarmina Hassan, MBSS, PhD, 267-473-0235, sarmina.hassan@tuhs.temple.edu
Laura Hart, MD
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 271057
Christina Tulbert, 336-716-2383, ctulbert@wakehealth.edu
David Stamilio, MD, MS
About this study
Official title: Collection of Pregnancy Outcome Data and Whole Blood Samples From Women Undergoing Non-Invasive Screening for Early, Preterm, and Term Preeclampsia
Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
Read the detailed description
To collect relevant pregnancy outcome data, medical history, and blood samples from pregnant women carrying a singleton fetus undergoing non-invasive screening for early, preterm and term pre-eclampsia (PE) starting at 11 weeks 0 days to 14 weeks 0 days (≥11 - ≤14) gestation in support of validating the Labcorp Preeclampsia ScreenTM assay. Data will be used to examine assay performance and develop new testing methods.
- Conditions
- Preeclampsia (PE)
- Keywords
- preeclampsia, pregnant
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant subjects between 11 and 14 weeks gestation. | This is an observational study and no study-specific intervention is defined. PE screen test results will not be reported back to the physician or subject but will be compared to birth outcome data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline serum samples will be used to evaluate the performance of the Labcorp Preeclampsia Screen assay
The results of the Preeclampsia Screen assay will be compared to pregnancy outcome data to evaluate how well the assay predicted early onset PE (<34 weeks gestational age) and preterm PE (<37 weeks gestational age).
Measured: From enrollment at 10-14 weeks gestation until pregnancy outcome is available, up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start2 Feb 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preeclampsia (PE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 6,550 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sequenom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rutgers Robert Wood Johnson Medical School, Laboratory Corporation of America
- Responsible party
- Sponsor
- Investigators
- Emily Rosenfeld, DO, Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643741
- Sponsor's protocol ID
- SQNM-PRE-401
- Status last verified
- Jul 2026
- First submitted
- 14 Oct 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Pregnancy Outcome Data and Whole Blood Samples From Women Undergoing Non-Invasive Screening for Early, Preterm, and Term Preeclampsia
- ClinicalTrials.gov ID
- NCT06643741
- Acronym / sponsor ID
- SQNM-PRE-401
- Conditions
- Preeclampsia (PE)
- Keywords
- preeclampsia, pregnant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,550 participants (estimated)
- Lead sponsor
- Sequenom, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Rutgers Robert Wood Johnson Medical School, Laboratory Corporation of America
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
Detailed description
To collect relevant pregnancy outcome data, medical history, and blood samples from pregnant women carrying a singleton fetus undergoing non-invasive screening for early, preterm and term pre-eclampsia (PE) starting at 11 weeks 0 days to 14 weeks 0 days (≥11 - ≤14) gestation in support of validating the Labcorp Preeclampsia ScreenTM assay. Data will be used to examine assay performance and develop new testing methods.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant subjects between 11 and 14 weeks gestation. | – | –This is an observational study and no study-specific intervention is defined. PE screen test results will not be reported back to the physician or subject but will be compared to birth outcome data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subject is pregnant with a singleton pregnancy at ≥11.0 - ≤14.0 weeks' gestation
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Baseline serum samples will be used to evaluate the performance of the Labcorp Preeclampsia Screen assay
Time frame: From enrollment at 10-14 weeks gestation until pregnancy outcome is available, up to 36 weeks
The results of the Preeclampsia Screen assay will be compared to pregnancy outcome data to evaluate how well the assay predicted early onset PE (<34 weeks gestational age) and preterm PE (<37 weeks gestational age).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Rosenfeld, DO principal investigator
Rutgers Robert Wood Johnson Medical School
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia (PE), run by Sequenom, Inc. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Graham McLennan, MS ((858) 202-9162, mclenng@labcorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline serum samples will be used to evaluate the performance of the Labcorp Preeclampsia Screen assay (time frame: From enrollment at 10-14 weeks gestation until pregnancy outcome is available, up to 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.