Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies

Completed

Conditions studied: Aneuploidy, Down Syndrome, Noninvasive Prenatal Screening

In brief

Pregnant women with low risk indicators for fetal chromosomal aneuploidy will be enrolled. Study blood will be collected in the first or second trimester at a scheduled prenatal screening visit, processed to plasma, and stored frozen until analysis. Each pregnancy will be followed until delivery and the birth outcome recorded.

Key facts

Study ID

NCT01597063

Run by

Sequenom, Inc.

People needed

3333

Starts

2012-07-01

Expected to finish

2015-12-01

Last updated by the study team

2016-04-20

Who can join

Age: 18 and older, up to 34. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pregnancy is 10-22 weeks gestation
• Between 18-34 years of age inclusive at estimated date of delivery
• No prenatal screening indicators for high risk including serum biochemical and ultrasound screening
• No personal or family history of Down syndrome
• Willing to provide written informed consent
• Willing to provide a whole blood sample
• Willing to provide access to medical records supporting fetal outcome

You may not qualify if…

• Fetal demise at the time of the blood draw
• Previous specimen donation under this protocol

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• New Horizon Women's Care — Chandler, Arizona, United States
• Precision Trials — Phoenix, Arizona, United States
• Visions Clinical Research Tuscon — Tucson, Arizona, United States
• Descanso OBGYN — Glendale, California, United States
• Woodglen Medical Group — Glendora, California, United States
• White Memorial GYN/OB Medical Group — Los Angeles, California, United States
• Fair Oaks Women's Health — Pasadena, California, United States
• IGO Medical Group — San Diego, California, United States
• West Coast OBGYN — San Diego, California, United States
• Women's Health Care Research — San Diego, California, United States
• Women's Clinical Research — Vista, California, United States
• Hawaii Pacific Health — Honolulu, Hawaii, United States
• University of Iowa Health Care — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Spectrum Health - Maternal Fetal Medicine — Grand Rapids, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Virtua Health — Moorestown, New Jersey, United States
• Virtua Health — Mount Holly, New Jersey, United States
• Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• Saint Peter's Hospital — New Brunswick, New Jersey, United States
• Virtua Health — Sewell, New Jersey, United States
• Virtua Health — Voorhees Township, New Jersey, United States
• Providence Health Partners - Center for Clinical Research — Dayton, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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