CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 354 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02278536
NCT02278536N/ACompleted

Development of Non-invasive Prenatal Diagnostic Test for Multiple Gestation Pregnancies Based on Fetal DNA Isolated From Maternal Blood

Natera, Inc.·observational·Posted Oct 30, 2014·Updated Aug 26, 2019

In Brief

An observational study for Trisomy 13 and 3 related conditions. Completed, enrolled 354 participants across 8 sites in 3 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesIndia, Malaysia, United States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 30, 2014
Enrollment StartMar 1, 2013
Primary CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 11.7 years ago