Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
354 participants
OBSERVATIONAL
2013-03-31
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Multiple high risk gestation pregnancies
women pregnant with twins or triplets at high risk for aneuploidy
No interventions assigned to this group
Multiple low risk gestation pregnancies
women pregnant with twins or triplets at low risk for aneuploidy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Surrogate or egg donor used
18 Years
ALL
Yes
Sponsors
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Houston Perinatal Associates
UNKNOWN
Lyndhurst Clinical Research
UNKNOWN
Dr. Carpenter Maternal Fetal Medicine Clinic
UNKNOWN
San Diego Perinatal Center
UNKNOWN
Natera, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Brian Kirshon, MD
Role: PRINCIPAL_INVESTIGATOR
Houston Perinatal Associates
Robert Lamar Parker, MD
Role: PRINCIPAL_INVESTIGATOR
Lyndhurst Clinical Research
Robert Carpenter, MD
Role: PRINCIPAL_INVESTIGATOR
Office of Dr. Robert Carpenter
Zach Demko, PhD
Role: PRINCIPAL_INVESTIGATOR
Natera, Inc.
Locations
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Natera, Inc.
San Carlos, California, United States
San Diego Perinatal Center
San Diego, California, United States
Carnegie Hill Imaging for Women
New York, New York, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Office of Dr. Robert Carpenter
Houston, Texas, United States
Houston Perinatal Associates
Houston, Texas, United States
Bangalore Fetal Medicine Centre
Bangalore, , India
Fetal Medicine & Gynaecology Centre
Petaling Jaya, Selangor, Malaysia
Countries
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References
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Pergament E, Cuckle H, Zimmermann B, Banjevic M, Sigurjonsson S, Ryan A, Hall MP, Dodd M, Lacroute P, Stosic M, Chopra N, Hunkapiller N, Prosen DE, McAdoo S, Demko Z, Siddiqui A, Hill M, Rabinowitz M. Single-nucleotide polymorphism-based noninvasive prenatal screening in a high-risk and low-risk cohort. Obstet Gynecol. 2014 Aug;124(2 Pt 1):210-218. doi: 10.1097/AOG.0000000000000363.
Ehrich M, Deciu C, Zwiefelhofer T, Tynan JA, Cagasan L, Tim R, Lu V, McCullough R, McCarthy E, Nygren AO, Dean J, Tang L, Hutchison D, Lu T, Wang H, Angkachatchai V, Oeth P, Cantor CR, Bombard A, van den Boom D. Noninvasive detection of fetal trisomy 21 by sequencing of DNA in maternal blood: a study in a clinical setting. Am J Obstet Gynecol. 2011 Mar;204(3):205.e1-11. doi: 10.1016/j.ajog.2010.12.060. Epub 2011 Feb 18.
Palomaki GE, Kloza EM, Lambert-Messerlian GM, Haddow JE, Neveux LM, Ehrich M, van den Boom D, Bombard AT, Deciu C, Grody WW, Nelson SF, Canick JA. DNA sequencing of maternal plasma to detect Down syndrome: an international clinical validation study. Genet Med. 2011 Nov;13(11):913-20. doi: 10.1097/GIM.0b013e3182368a0e.
Sehnert AJ, Rhees B, Comstock D, de Feo E, Heilek G, Burke J, Rava RP. Optimal detection of fetal chromosomal abnormalities by massively parallel DNA sequencing of cell-free fetal DNA from maternal blood. Clin Chem. 2011 Jul;57(7):1042-9. doi: 10.1373/clinchem.2011.165910. Epub 2011 Apr 25.
Bianchi DW, Platt LD, Goldberg JD, Abuhamad AZ, Sehnert AJ, Rava RP; MatErnal BLood IS Source to Accurately diagnose fetal aneuploidy (MELISSA) Study Group. Genome-wide fetal aneuploidy detection by maternal plasma DNA sequencing. Obstet Gynecol. 2012 May;119(5):890-901. doi: 10.1097/AOG.0b013e31824fb482.
Palomaki GE, Deciu C, Kloza EM, Lambert-Messerlian GM, Haddow JE, Neveux LM, Ehrich M, van den Boom D, Bombard AT, Grody WW, Nelson SF, Canick JA. DNA sequencing of maternal plasma reliably identifies trisomy 18 and trisomy 13 as well as Down syndrome: an international collaborative study. Genet Med. 2012 Mar;14(3):296-305. doi: 10.1038/gim.2011.73. Epub 2012 Feb 2.
Norton ME, Brar H, Weiss J, Karimi A, Laurent LC, Caughey AB, Rodriguez MH, Williams J 3rd, Mitchell ME, Adair CD, Lee H, Jacobsson B, Tomlinson MW, Oepkes D, Hollemon D, Sparks AB, Oliphant A, Song K. Non-Invasive Chromosomal Evaluation (NICE) Study: results of a multicenter prospective cohort study for detection of fetal trisomy 21 and trisomy 18. Am J Obstet Gynecol. 2012 Aug;207(2):137.e1-8. doi: 10.1016/j.ajog.2012.05.021. Epub 2012 Jun 1.
Canick JA, Kloza EM, Lambert-Messerlian GM, Haddow JE, Ehrich M, van den Boom D, Bombard AT, Deciu C, Palomaki GE. DNA sequencing of maternal plasma to identify Down syndrome and other trisomies in multiple gestations. Prenat Diagn. 2012 Aug;32(8):730-4. doi: 10.1002/pd.3892. Epub 2012 May 14.
Other Identifiers
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13-016-NPT
Identifier Type: -
Identifier Source: org_study_id
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