Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies

Completed

• Conditions: Down Syndrome; Noninvasive Prenatal Screening; Aneuploidy
• Interventions: Device: SEQureDx Trisomy Test

• Registration Number: NCT01597063
• Lead Sponsor: Sequenom, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-09
• Study First Submitted QC: 2012-05-10
• Study First Posted: 2012-05-11
• Study Start: 2012-07
• Primary Completion: 2014-02
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3333

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
low risk pregnancies	SEQureDx Trisomy Test	-

Primary Outcome Measures

Name	Time	Method
Estimate the false positive rate of SEQureDx Trisomy 21 Test	pregnancy outcome

Trial Locations

Locations (24)

Virtua Health; 🇺🇸 Voorhees, New Jersey, United States

Visions Clinical Research Tuscon; 🇺🇸 Tucson, Arizona, United States

University of South Alabama; 🇺🇸 Mobile, Alabama, United States

New Horizon Women's Care; 🇺🇸 Chandler, Arizona, United States

Fair Oaks Women's Health; 🇺🇸 Pasadena, California, United States

Descanso OBGYN; 🇺🇸 Glendale, California, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

IGO Medical Group; 🇺🇸 San Diego, California, United States

Women's Health Care Research; 🇺🇸 San Diego, California, United States

Saint Peter's Hospital; 🇺🇸 New Brunswick, New Jersey, United States

Jersey Shore University Medical Center; 🇺🇸 Neptune, New Jersey, United States

Precision Trials; 🇺🇸 Phoenix, Arizona, United States

University of Iowa Health Care; 🇺🇸 Iowa City, Iowa, United States

White Memorial GYN/OB Medical Group; 🇺🇸 Los Angeles, California, United States

Women's Clinical Research; 🇺🇸 Vista, California, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Woodglen Medical Group; 🇺🇸 Glendora, California, United States

West Coast OBGYN; 🇺🇸 San Diego, California, United States

Providence Health Partners - Center for Clinical Research; 🇺🇸 Dayton, Ohio, United States

Magnolia OB/GYN Research Center- Recruiting; 🇺🇸 Myrtle Beach, South Carolina, United States

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Hawaii Pacific Health; 🇺🇸 Honolulu, Hawaii, United States

Spectrum Health - Maternal Fetal Medicine; 🇺🇸 Grand Rapids, Michigan, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States