Multiple Gestation Study

Completed

• Conditions: Trisomy 18; Sex Chromosome Abnormalities; Trisomy 13; Trisomy 21

• Registration Number: NCT02278536
• Lead Sponsor: Natera, Inc.

Brief Summary

The objectives of the clinical study are to demonstrate the accuracy of our new NATUS diagnostic method to determine the genetic health of the developing fetuses in a multiple gestation pregnancy from a maternal blood sample. The long term goal of this study will be the development of a method of minimally invasive prenatal diagnosis that has a higher sensitivity and lower false positive rate in the intended population (e.g. multiple gestation pregnancies) than any currently available screening tests. This will result in fewer unnecessary amniocenteses and CVS procedures, which are associated with a risk of miscarriage.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-10-28
• Study First Submitted QC: 2014-10-28
• Study First Posted: 2014-10-30
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 354

Inclusion Criteria

• Age 18 or older at enrollment
• Clinically confirmed multiple gestation pregnancy
• Gestational age between ≥ 9 weeks, 0 days and ≤26 weeks 0 days by best obstetrical estimate
• Able to provide informed consent

Exclusion Criteria

• Women carrying singleton pregnancy
• Surrogate or egg donor used

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be to confirm the diagnostic capability of NATUS risk results classified as positive result for aneuploidy, negative result for aneuploidy or 'no call.'	2 years	The chromosomal status will be determined from the CVS or amniocentesis results, if available. A cheek swab or saliva sample will be collected from live-born children if there are no CVS or amniocentesis results.

Trial Locations

Locations (8)

Fetal Medicine & Gynaecology Centre; 🇲🇾 Petaling Jaya, Selangor, Malaysia

Carnegie Hill Imaging for Women; 🇺🇸 New York, New York, United States

Office of Dr. Robert Carpenter; 🇺🇸 Houston, Texas, United States

Houston Perinatal Associates; 🇺🇸 Houston, Texas, United States

Bangalore Fetal Medicine Centre; 🇮🇳 Bangalore, India

Natera, Inc.; 🇺🇸 San Carlos, California, United States

San Diego Perinatal Center; 🇺🇸 San Diego, California, United States

Lyndhurst Clinical Research; 🇺🇸 Winston-Salem, North Carolina, United States