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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02278536
Date of registration:	28/10/2014
Prospective Registration:	No
Primary sponsor:	Natera, Inc.
Public title:	Multiple Gestation Study
Scientific title:	Development of Non-invasive Prenatal Diagnostic Test for Multiple Gestation Pregnancies Based on Fetal DNA Isolated From Maternal Blood
Date of first enrolment:	March 2013
Target sample size:	354
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02278536
Study type:	Observational
Study design:
Phase:

Countries of recruitment
India	Malaysia	United States

Contacts

Name:	Robert Lamar Parker, MD
Address:
Telephone:
Email:
Affiliation:	Lyndhurst Clinical Research

Name:	Robert Carpenter, MD
Address:
Telephone:
Email:
Affiliation:	Office of Dr. Robert Carpenter

Name:	Brian Kirshon, MD
Address:
Telephone:
Email:
Affiliation:	Houston Perinatal Associates

Name:	Zach Demko, PhD
Address:
Telephone:
Email:
Affiliation:	Natera, Inc.

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Sex Chromosome Abnormalities

Trisomy 18

Trisomy 13

Trisomy 21

Intervention(s)

Primary Outcome(s)

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]

Secondary Outcome(s)

Secondary ID(s)

13-016-NPT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Dr. Carpenter Maternal Fetal Medicine Clinic

San Diego Perinatal Center

Lyndhurst Clinical Research

Houston Perinatal Associates

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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