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Prenatal Testing: Amniocentesis Versus Transabdominal Chorionic Villus Sampling (TA CVS)

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00065897
First received: August 1, 2003
Last updated: June 23, 2005
Last verified: June 2003

August 1, 2003
June 23, 2005
September 1996
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Complete list of historical versions of study NCT00065897 on ClinicalTrials.gov Archive Site
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Prenatal Testing: Amniocentesis Versus Transabdominal Chorionic Villus Sampling (TA CVS)
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.

Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Pregnancy
  • Procedure: Amniocentesis
  • Procedure: Transabdominal chorionic villus sampling (TA CVS)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6400
August 2000
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Inclusion Criteria

  • Singleton pregnancy confirmed by baseline ultrasound
  • At least 77 days gestation but not more than 104 days gestation confirmed by baseline ultrasound

Exclusion Criteria

  • Evidence of "vanishing" twin
  • Bleeding equivalent to a menstrual period at any time during this pregnancy
  • Medical history indicating serious maternal illness or potential teratogenic exposure
  • Oligohydramnios
  • Known fetal abnormality
  • Dating inconsistency: if the estimated gestation is 8 or more days less than estimated by LMP, the patient is excluded unless interval growth by ultrasound confirms the normalcy of the pregnancy
Female
34 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00065897
5R01HD031991, 1R01HD32109
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Laird G. Jackson, M.D. Drexel University College of Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
June 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP