This application accompanies a proposal entitled """"""""Randomized Trial of 11-14 Week Amniocentesis and TA CVS"""""""" submitted by Dr. Laird Jackson leading a group of twelve clinical centers. Together the proposals request funding for a multi-center randomized clinical trial of amniocentesis and transabdominal chorionic villus sampling (TA CVS) at 77-14 days gestation. This application proposes The George Washington University/Biostatistics Center as the Data Coordinating Center (DCC) for the study. The purpose of the study is to compare the two prenatal diagnosis techniques with regard to safety, measured primarily by a combined endpoint of fetal loss or preterm delivery before 196 days gestation and also by total fetal loss, amniotic fluid, gestational age at delivery, perinatal morbidity, neonatal morbidity and congenital abnormalities, including limb reduction effects. Success in obtaining a diagnosis from the two procedures will be compared. An ancillary study will evaluate the feasibility and accuracy of fluorescence in situ hybridization (FISH) as a rapid diagnostic method for certain cytogenetic abnormalities. A total of 6400 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 or trisomy in a previous pregnancy will be randomized to receive either TA CVS or amniocentesis following a baseline ultrasound. Five thousand eligible women who refuse randomization or for whom a procedure cannot be scheduled by 104 days will also be followed, one thousand of whom will have a standard amniocentesis procedure. The DCC will assist the group in implementing the study by: (1) setting up a randomization procedure;' (2) training study personnel; (3) setting up a computerized data processing an editing system; (4) monitoring recruitment, protocol adherence and data quality; (5) preparing interim analyses of the results for a Safety monitoring Committee; (6) conducting final analyses and preparing the publication of results; and (7) documenting the final data base.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD032109-02
Application #
2403415
Study Section
Special Emphasis Panel (SRC (JT))
Project Start
1996-09-16
Project End
2000-08-31
Budget Start
1997-09-01
Budget End
1998-08-31
Support Year
2
Fiscal Year
1997
Total Cost
Indirect Cost
Name
George Washington University
Department
Biostatistics & Other Math Sci
Type
Schools of Arts and Sciences
DUNS #
City
Washington
State
DC
Country
United States
Zip Code
20052
Goetzl, Laura (2010) Adverse pregnancy outcomes after abnormal first-trimester screening for aneuploidy. Clin Lab Med 30:613-28
Silver, Richard K; Wilson, R Douglas; Philip, John et al. (2005) Late first-trimester placental disruption and subsequent gestational hypertension/preeclampsia. Obstet Gynecol 105:587-92
Wapner, Ronald J (2005) First trimester screening: the BUN study. Semin Perinatol 29:236-9
Bahado-Singh, Ray O; Wapner, Ronald; Thom, Elizabeth et al. (2005) Elevated first-trimester nuchal translucency increases the risk of congenital heart defects. Am J Obstet Gynecol 192:1357-61
Goetzl, Laura; Krantz, David; Simpson, Joe Leigh et al. (2004) Pregnancy-associated plasma protein A, free beta-hCG, nuchal translucency, and risk of pregnancy loss. Obstet Gynecol 104:30-6
Philip, J; Silver, R K; Wilson, R D et al. (2004) Late first-trimester invasive prenatal diagnosis: results of an international randomized trial. Obstet Gynecol 103:1164-73
Platt, Lawrence D; Greene, Naomi; Johnson, Anthony et al. (2004) Sequential pathways of testing after first-trimester screening for trisomy 21. Obstet Gynecol 104:661-6
Krantz, David; Goetzl, Laura; Simpson, Joe Leigh et al. (2004) Association of extreme first-trimester free human chorionic gonadotropin-beta, pregnancy-associated plasma protein A, and nuchal translucency with intrauterine growth restriction and other adverse pregnancy outcomes. Am J Obstet Gynecol 191:1452-8
Wapner, Ronald; Thom, Elizabeth; Simpson, Joe Leigh et al. (2003) First-trimester screening for trisomies 21 and 18. N Engl J Med 349:1405-13