What this study is
Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
Study details
- Official title
- Collection of Pregnancy Outcome Data and Whole Blood Samples From Women Undergoing Non-Invasive Screening for Early, Preterm, and Term Preeclampsia
- Sponsor
- Sequenom, Inc.
- Conditions
- Preeclampsia (PE)
- Enrolling
- 6,550 people
- Starts
- 2025-02-02
- Est. completion
- 2027-07-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (21)
20 openValley Perinatal
Glendale, Arizona, United States
- Tina Rommes · Contact480-660--4040amin@valleyperinatal.com
- Ravindu Gunatilake, MD · Principal investigator
RecruitingDelaware Center for Maternal and Fetal Medicine
Newark, Delaware, United States
- Carrie Kitto · Contact302-319-5680ckitto@christianacare.org
- Suneet Chauhan, MD, DSc · Principal investigator
RecruitingSouthern Clinical Research Associates
Metairie, Louisiana, United States
- Shaune Braud, RN · Contact504-810-4414sbraud@scrallc.com
- Samuel Alexander, MD · Principal investigator
RecruitingBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
- Anna Modest · Contact781-956-5282ammodest@bidmc.harvard.edu
- Cassandra Duffy, MD, MPH · Principal investigator
Not yet recruitingCooper University Health Care
Camden, New Jersey, United States
- Ankur Patel · Contact856-342-2000 ext. 1007032patel-ankur@cooperhealth.edu
- Robin Perry, MD, MSEd · Principal investigator
Not yet recruitingNew Jersey Perinatal Associates
Livingston, New Jersey, United States
- Megha Soni · Contactmsoni@njperinatal.com
- Kathy Mathews, MD · Principal investigator
RecruitingRutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
- Emily Rosenfeld, DO · Contact(732) 235-6200er720@rwjms.rutgers.edu
- Emily Rosenfeld, DO · Principal investigator
RecruitingCapital Health
Pennington, New Jersey, United States
- Saadia Kazmi · Contact609-3944-130skazmi@capitalhealth.org
- Thomas Westover, MD · Principal investigator
RecruitingColumbia University Medical Center
New York, New York, United States
- Casandra Almonte · Contact646-284-5360ca2344@cumc.columbia.edu
- Eve Overton, MD · Principal investigator
RecruitingLenox Hill Hospital
New York, New York, United States
- Tamika Wong · Contact212-434-4836twong4@northwell.edu
- Eran Bornstein, MD · Principal investigator
RecruitingWake Forest University Health Sciences
Winston-Salem, North Carolina, United States
- Christina Tulbert · Contact336-716-2383ctulbert@wakehealth.edu
- David Stamilio, MD, MS · Principal investigator
RecruitingGeisinger Medical Center
Danville, Pennsylvania, United States
- Cynthia Drazenovich · Contact570-271-8667cdrazenovich1@geisinger.edu
- Michael Paglia, MD, PhD · Principal investigator
Not yet recruitingUniversity of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, United States
- Elaina Symes · Contact267-438-2709Elaina.symes@pennmedicine.UPenn.edu
- Lorraine Dugoff, MD · Principal investigator
RecruitingLewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, United States
- Sarmina Hassan, MBSS, PhD · Contact267-473-0235sarmina.hassan@tuhs.temple.edu
- Laura Hart, MD · Principal investigator
Not yet recruitingChattanooga Medical Research
Chattanooga, Tennessee, United States
- Yvonne Chester · Contact423-648-7794ychester@chattmedresearch.com
- Scott Harsberger, MD · Principal investigator
RecruitingSt. David's Women's Center of Texas
Austin, Texas, United States
- Adrianna Knight, BSN, RN · Contact512-493-6925adrianna.knight@stdavids.com
- Mollie McDonnold, MD · Principal investigator
RecruitingUniversity of Texas Medical Branch
Galveston, Texas, United States
- Sonia Robazetti, RN · Contactscrobaze@utmb.edu
- Hassan Harirah, MD, FRCSC · Principal investigator
RecruitingUT Health
Houston, Texas, United States
- Sunbola S Ashimi · Contact(713) 500-6484sunbola.s.ashimi@uth.tmc.edu
- Baha M Sibai, MD · Principal investigator
RecruitingHCA Healthcare, Texas Maternal Fetal Medicine
Houston, Texas, United States
- Valencia Moore, BSN, RN · Contact346-581-4802valencia.moore@hcahealthcare.com
- David Kennedy · Contact832-237-6301david.kennedy@hcahealthcare.com
- Kjersti Aagaard, MD, PhD, FACOG · Principal investigator
RecruitingMacon & Joan Brock Virginia Health Sciences at Old Dominion University
Norfolk, Virginia, United States
- Caitlyn Mcadams · Contact(757) 446-5653cmcadams@odu.edu
- George Saade, MD · Principal investigator
RecruitingD&H National Research Centers
Miami, Florida, United States
Terminated
Study team
Sponsor
Sequenom, Inc.
Study ID SQNM-PRE-401
Principal investigator
Emily Rosenfeld, DO
Rutgers Robert Wood Johnson Medical School
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.