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
  Purpose

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).


Condition Intervention
Pregnancy
Procedure: Amniocentesis
Procedure: Transabdominal chorionic villus sampling (TA CVS)

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

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 6400
Study Start Date: September 1996
Estimated Study Completion Date: August 2000
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.

  Eligibility

Ages Eligible for Study:   34 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065897

Sponsors and Collaborators
Investigators
Principal Investigator: Laird G. Jackson, M.D. Drexel University College of Medicine
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00065897     History of Changes
Other Study ID Numbers: 5R01HD031991, 1R01HD32109
Study First Received: August 1, 2003
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Amniocentesis
Transabdominal chorionic villus sampling
Fluorescence in situ hybridization
Alpha fetoprotein
Acetylcholinesterase
Prenatal testing
Prenatal diagnosis

ClinicalTrials.gov processed this record on April 21, 2014