Ignite Creation Date:
2024-05-05 @ 9:22 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00871195
Status:
COMPLETED
Last Update Posted:
2012-05-10
First Post:
2009-03-26
Brief Title:
A Noninvasive Test for Fetal RHD Genotype
Sponsor:
Sequenom Inc
Organization:
Sequenom Inc
Study Overview
Official Title:
Evaluation Of The Performance Of A Noninvasive Test For Fetal RHD Genotype On The Sequenom MassARRAY System
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAFTnet RHD
Brief Summary:
The objective of this study is to evaluate the performance of Sequenoms noninvasive test for fetal RHD genotype The test uses MALDI-TOF mass spectrometry to detect DNA The study is specifically designed to determine whether RHD typing using free fetal DNA in maternal circulation can accurately predict the neonatal RhD phenotype at birth
Detailed Description:
In the United States and Canada routine obstetrical care includes a blood test to determine the blood type of the mother ABO and RhD An antibody screen for anti-red cell antibodies in the mothers serum is also performed
Postpartum prophylactic treatment of RhD negative women with anti-D immunoglobulin to prevent RhD Disease or hemolytic disease of the fetusnewborn was initiated in the 1960s In the mid 1980s the routine administration of antenatal anti-D immunoglobulin became the standard of care as well Although these treatments have dramatically reduced the incidence of RhD Disease approximately 40 of all RhD negative pregnancies continue to receive unnecessary injections of antenatal anti-D immunoglobulin
Genotyping platforms such as MALDI-TOF mass spectrometry allow for precise and sensitive detection of fetal-specific paternally derived alleles in maternal plasma In this study Sequenoms MassARRAY technology will be used to assess a noninvasive test for fetal RHD genotyping in a clinical setting
Postpartum prophylactic treatment of RhD negative women with anti-D immunoglobulin to prevent RhD Disease or hemolytic disease of the fetusnewborn was initiated in the 1960s In the mid 1980s the routine administration of antenatal anti-D immunoglobulin became the standard of care as well Although these treatments have dramatically reduced the incidence of RhD Disease approximately 40 of all RhD negative pregnancies continue to receive unnecessary injections of antenatal anti-D immunoglobulin
Genotyping platforms such as MALDI-TOF mass spectrometry allow for precise and sensitive detection of fetal-specific paternally derived alleles in maternal plasma In this study Sequenoms MassARRAY technology will be used to assess a noninvasive test for fetal RHD genotyping in a clinical setting
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None