Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065897
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2003-08-01
Brief Title:
Prenatal Testing Amniocentesis Versus Transabdominal Chorionic Villus Sampling TA CVS
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Randomized Trial of 11-14 Week Amniocentesis and Transabdominal Chorionic Villus Sampling TA CVS
Status:
COMPLETED
Status Verified Date:
2003-06
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:
None
Brief Summary:
Prenatal diagnosis can provide information to parents about specific fetal disorders However invasive prenatal diagnostic procedures are associated with risks to the fetus This study will compare the safety and effectiveness of two methods of invasive prenatal diagnosis amniocentesis and transabdominal chorionic villus sampling TA CVS
Detailed Description:
Amniocentesis is generally performed at 105 to 125 days post last menstrual period LMP and TA CVS at 63 to 76 days post LMP This study will compare the safety and accuracy of transabdominal amniocentesis and TA CVS each performed during the same modified gestational age window of 77 to 104 days post LMP
Healthy pregnant women at 77 to 104 days gestation whose only indication for prenatal diagnosis is advanced maternal age of at least 34 years at enrollment will be randomized to receive either TA CVS or amniocentesis following a baseline ultrasound Eligible women who refuse randomization or for whom a procedure cannot be scheduled by 104 days will also be followed Primary outcomes include fetal loss or preterm delivery before 196 days gestation as well as total fetal loss amniotic fluid loss gestational age at delivery perinatal morbidity neonatal morbidity and congenital abnormalities including limb reduction defects Success in obtaining a diagnosis from the two procedures will be compared One ancillary study will evaluate the feasibility and accuracy of fluorescence in situ hybridization FISH as a rapid diagnostic method for certain cytogenetic abnormalities another will collect data on amniotic fluid alphafetoprotein and acetylcholinesterase for the diagnosis of neural tube defects
Healthy pregnant women at 77 to 104 days gestation whose only indication for prenatal diagnosis is advanced maternal age of at least 34 years at enrollment will be randomized to receive either TA CVS or amniocentesis following a baseline ultrasound Eligible women who refuse randomization or for whom a procedure cannot be scheduled by 104 days will also be followed Primary outcomes include fetal loss or preterm delivery before 196 days gestation as well as total fetal loss amniotic fluid loss gestational age at delivery perinatal morbidity neonatal morbidity and congenital abnormalities including limb reduction defects Success in obtaining a diagnosis from the two procedures will be compared One ancillary study will evaluate the feasibility and accuracy of fluorescence in situ hybridization FISH as a rapid diagnostic method for certain cytogenetic abnormalities another will collect data on amniotic fluid alphafetoprotein and acetylcholinesterase for the diagnosis of neural tube defects
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HD032109 | NIH | None | httpsreporternihgovquickSearch1R01HD032109 |