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.
Full Title of Study: “Development of Non-invasive Prenatal Diagnostic Test for Multiple Gestation Pregnancies Based on Fetal DNA Isolated From Maternal Blood”
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: March 2019
Arms, Groups and Cohorts
- Multiple high risk gestation pregnancies
- women pregnant with twins or triplets at high risk for aneuploidy
- Multiple low risk gestation pregnancies
- women pregnant with twins or triplets at low risk for aneuploidy
Clinical Trial Outcome Measures
- 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.’
- Time Frame: 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.
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Natera, Inc.
- Houston Perinatal Associates
- Provider of Information About this Clinical Study
- Overall Official(s)
- Brian Kirshon, MD, Principal Investigator, Houston Perinatal Associates
- Robert Lamar Parker, MD, Principal Investigator, Lyndhurst Clinical Research
- Robert Carpenter, MD, Principal Investigator, Office of Dr. Robert Carpenter
- Zach Demko, PhD, Principal Investigator, Natera, Inc.
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