Multiple Gestation Study

Sponsor

Natera, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02278536

Collaborator

Houston Perinatal Associates (Other), Lyndhurst Clinical Research (Other), Dr. Carpenter Maternal Fetal Medicine Clinic (Other), San Diego Perinatal Center (Other)

354

Enrollment

Locations

Duration (Months)

44.3

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trisomy 13 Trisomy 18 Trisomy 21 Sex Chromosome Abnormalities

Study Design

Study Type:

Observational

Actual Enrollment :

354 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary 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.' [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Natera, Inc.	San Carlos	California	United States	94070
2	San Diego Perinatal Center	San Diego	California	United States	92123
3	Carnegie Hill Imaging for Women	New York	New York	United States	10128
4	Lyndhurst Clinical Research	Winston-Salem	North Carolina	United States	27103
5	Office of Dr. Robert Carpenter	Houston	Texas	United States	77030
6	Houston Perinatal Associates	Houston	Texas	United States	77054
7	Bangalore Fetal Medicine Centre	Bangalore		India
8	Fetal Medicine & Gynaecology Centre	Petaling Jaya	Selangor	Malaysia