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Trial record 4 of 18 for:    "trisomy 13"

Multiple Gestation Study

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ClinicalTrials.gov Identifier: NCT02278536
Recruitment Status : Recruiting
First Posted : October 30, 2014
Last Update Posted : April 14, 2017
Sponsor:
Collaborators:
Houston Perinatal Associates
Lyndhurst Clinical Research
Dr. Carpenter Maternal Fetal Medicine Clinic
San Diego Perinatal Center
Information provided by (Responsible Party):
Natera, Inc.

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
Trisomy 13 Trisomy 18 Trisomy 21 Sex Chromosome Abnormalities

Study Type : Observational
Estimated Enrollment : 200 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 : March 2013
Estimated Primary Completion Date : December 2018


Group/Cohort
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



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA

Maternal and Paternal blood samples

CVS or Amniocentesis sample (optional)

Child saliva sample (optional)

*Biospecimen retention is optional portion of consent form



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant Women
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278536


Contacts
Contact: Melissa Schirmer 650-249-9090 ext 696 research@natera.com

Locations
United States, California
Natera, Inc. Recruiting
San Carlos, California, United States, 94070
Principal Investigator: Zach Demko, PhD         
San Diego Perinatal Center Recruiting
San Diego, California, United States, 92123
Contact: Perla Gomez    858-966-6710    pgomez@rchsd.org   
United States, New York
Carnegie Hill Imaging for Women Active, not recruiting
New York, New York, United States, 10128
United States, North Carolina
Lyndhurst Clinical Research Active, not recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Texas
Office of Dr. Robert Carpenter Active, not recruiting
Houston, Texas, United States, 77030
Houston Perinatal Associates Recruiting
Houston, Texas, United States, 77054
Contact: Beckie Rodriguez, LVN    713-791-9700 ext 121    brodriguez@houstonperinatal.com   
Principal Investigator: Robert Kirshon, MD         
India
Bangalore Fetal Medicine Centre Recruiting
Bangalore, India
Contact: Prathima Radhakrishan, FRCOG    +91 99720 14081      
Malaysia
Fetal Medicine & Gynaecology Centre Recruiting
Selangor, Malaysia
Contact: Patrick Chia, MD    603 7956 3887    enquires@fmgc.com.my   
Sponsors and Collaborators
Natera, Inc.
Houston Perinatal Associates
Lyndhurst Clinical Research
Dr. Carpenter Maternal Fetal Medicine Clinic
San Diego Perinatal Center
Investigators
Principal Investigator: Brian Kirshon, MD Houston Perinatal Associates
Principal Investigator: Robert Lamar Parker, MD Lyndhurst Clinical Research
Principal Investigator: Robert Carpenter, MD Office of Dr. Robert Carpenter
Principal Investigator: Zach Demko, PhD Natera, Inc.

Additional Information:
Publications:

Responsible Party: Natera, Inc.
ClinicalTrials.gov Identifier: NCT02278536     History of Changes
Other Study ID Numbers: 13-016-NPT
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

Keywords provided by Natera, Inc.:
Trisomy 13
Trisomy 18
Trisomy 21
Sex Chromosome Abnormalities
Monosomy X
XXX
XXY
XYY

Additional relevant MeSH terms:
Congenital Abnormalities
Trisomy
Down Syndrome
Chromosome Aberrations
Chromosome Disorders
Sex Chromosome Aberrations
Aneuploidy
Pathologic Processes
Chromosome Duplication
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Genetic Diseases, Inborn