Pregnancy Clinical Trial
Official title:
Randomized Trial of 11-14 Week Amniocentesis and Transabdominal Chorionic Villus Sampling (TA CVS)
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).
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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