CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 99 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/NCT02278874
NCT02278874N/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 Jun 13, 2019

In Brief

An observational study for Trisomy 13 and 3 related conditions. Completed, enrolled 99 participants across 4 sites.

Detailed Summary

The objectives of the clinical study are to demonstrate the accuracy of our proprietary algorithm 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 other currently available screening tests. This will result in fewer unnecessary amniocenteses and Chorionic Villus Sample (CVS) procedures, which are associated with a risk of miscarriage.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 30, 2014
Enrollment StartAug 1, 2014
Primary CompletionDec 1, 2018
Study CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 11.7 years ago