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

NCT00065897 | Completed

• 2 other identifiers: 5R01HD0319911R01HD032109
• Study Type: interventional
• Target: 6,400
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pregnancy

Keywords

Amniocentesis; Transabdominal chorionic villus sampling; Fluorescence in situ hybridization; Alpha fetoprotein; Acetylcholinesterase; Prenatal testing; Prenatal diagnosis

Interventions

Amniocentesis PROCEDURE

Transabdominal chorionic villus sampling (TA CVS) PROCEDURE

Eligibility Criteria

• Age: 34 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Related Publications (2)

• 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.

  PMID: 1640952 BACKGROUND

• 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.

  PMID: 2309757 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Amniocentesis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Paracentesis; Specimen Handling; Prenatal Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Laird G. Jackson, M.D.

  Drexel University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 1, 2003
• First Posted: August 5, 2003
• Study Start: September 1, 1996
• Study Completion: August 1, 2000
• Last Updated: June 24, 2005

Record last verified: 2003-06