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).
Status | Completed |
Enrollment | 6400 |
Est. completion date | August 2000 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 34 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Elejalde BR, de Elejalde MM, Acuña 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. — View 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. — View Citation
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