Clinical Performance of NIPT in Multiple Gestation Pregnancies
Clinical Performance of NIPT (Noninvasive Prenatal Testing) in Multiple Gestation Pregnancies (SCMM-T21-110)
1 other identifier
observational
2,000
1 country
1
Brief Summary
This study plans to evaluate the clinical performance of the MaterniT21 PLUS and/or GENOME Laboratory Developed Test, in the detection of fetal trisomy 21 in circulating cell-free DNA extracted from maternal blood samples obtained from women pregnant with a twin gestation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
July 22, 2020
CompletedFirst Posted
Study publicly available on registry
July 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2022
CompletedDecember 7, 2022
December 1, 2022
1.7 years
July 22, 2020
December 5, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Determination of sensitivity of NIPT detection of trisomy 21 among a population of women with twin gestations.
time from maternal blood draw to delivery
Determination of specificity of NIPT detection of trisomy 21 among a population of women with twin gestations.
time from maternal blood draw to delivery
Study Arms (1)
Pregnancies with multiple gestations
Interventions
Both the MaterniT21 PLUS and GENOME are intended for use as laboratory developed test that analyze ccfDNA extracted from a maternal blood sample utilizing Massively Parallel Sequencing (MPS) technology.
Eligibility Criteria
The Study Population will consist of women 18 years of age and older who underwent testing with a Sequenom NIPT, were pregnant with a multiple gestation at the time of testing and whose pregnancies should have outcome based upon gestational age at the time of testing.
You may qualify if:
- subject pregnant with a multiple gestation and received NIPT from Sequenom Laboratories;
- subject was 18 or older at the time of NIPT
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
Siegel MR, James K, Bromley B, Koelper NC, Chasen ST, Griffin L, Roman AS, Limaye M, Ranzini A, Clifford C, Biggio JR, Subramaniam A, Seasely AR, Page JM, Nicholas SS, Idler J, Rao R, Shree R, McLennan G, Dugoff L; Twin cfDNA Study Consortium. First-Trimester Cell-Free DNA Fetal Fraction and Birth Weight in Twin Pregnancies. Am J Perinatol. 2025 Apr;42(5):605-611. doi: 10.1055/a-2413-2353. Epub 2024 Sep 11.
PMID: 39260415DERIVED
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Obstetrics and Gynecology
Study Record Dates
First Submitted
July 22, 2020
First Posted
July 28, 2020
Study Start
March 1, 2020
Primary Completion
November 15, 2021
Study Completion
June 19, 2022
Last Updated
December 7, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share