High Risk Multiple Gestation Study
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Other Indications, Women's Studies |
| Therapuetic Areas: | Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/12/2018 |
| Start Date: | August 2014 |
| End Date: | December 1, 2018 |
Development of Non-invasive Prenatal Diagnostic Test for Multiple Gestation Pregnancies Based on Fetal DNA Isolated From Maternal Blood
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.
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.
Inclusion Criteria:
- Age 18 or older at enrollment
- Clinically confirmed multiple gestation pregnancy
- Pregnancy at high risk for genetic aneuploidy as defined below:
- Confirmed positive aneuploidy by invasive testing
- Non invasive prenatal testing "high risk" result
- Serum screening risk of greater than 1:100
- Ultrasound abnormalities indicative of aneuploidy
- Structural abnormality of the posterior fossa
- Holoprosencephaly
- Structural cardiac anomaly
- Omphalocele
- Nuchal translucency greater than or equal to 3.5 mm or a nuchal fold greater
Hydrops of unknown etiology
- Age ≥ 38 years at delivery (if serum screening risk is not less than 1:100)
- 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
We found this trial at
4
sites
800 Washington St
Boston, Massachusetts 02111
Boston, Massachusetts 02111
(617) 636-5000
Phone: 617-636-0186
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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3550 Jerome Avenue
Bronx, New York 10467
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Peer Dar, MD
Phone: 718-405-8214
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Glen Cove, New York 11542
Principal Investigator: Rajeevi Madankumar, MD
Phone: 718-470-5563
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New York, New York 10029
Principal Investigator: Joanne Stone, MD
Phone: 212-241-3888
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