Purpose

Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Case-Control
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555
Contact:
Sonia Robazetti, RN
scrobaze@utmb.edu

More Details

Status
Recruiting
Sponsor
Sequenom, Inc.

Study Contact

Graham McLennan, MS
(858) 202-9162
mclenng@labcorp.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.