Clinical trial NCT00065897: Prenatal Testing: Amniocentesis Versus Transabdominal Chorionic Villus Sampling (TA CVS)
Official title: Randomized Trial of 11-14 Week Amniocentesis and Transabdominal Chorionic Villus Sampling (TA CVS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Amniocentesis
Transabdominal chorionic villus sampling
Fluorescence in situ hybridization
Alpha fetoprotein
Acetylcholinesterase
Prenatal testing
Prenatal diagnosis
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2003-08-05
Enrollment: 6400
Sex: FEMALE
Minimum age (years): 34
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Drexel University College of Medicine
name: Laird G. Jackson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jackson LG, Zachary JM, Fowler SE, Desnick RJ, Golbus MS, Ledbetter DH, Mahoney MJ, Pergament E, Simpson JL, Black S, et al. A randomized comparison of transcervical and transabdominal chorionic-villus sampling. The U.S. National Institute of Child Health and Human Development Chorionic-Villus Sampling and Amniocentesis Study Group. N Engl J Med. 1992 Aug 27;327(9):594-8. doi: 10.1056/NEJM199208273270903.
citation: Elejalde BR, de Elejalde MM, Acuna JM, Thelen D, Trujillo C, Karrmann M. Prospective study of amniocentesis performed between weeks 9 and 16 of gestation: its feasibility, risks, complications and use in early genetic prenatal diagnosis. Am J Med Genet. 1990 Feb;35(2):188-96. doi: 10.1002/ajmg.1320350210.