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Late First-Trimester Invasive Prenatal Diagnosis: Results of an International Randomized Trial

J Philip, MD^*, R K. Silver, MD, R D. Wilson, MD, E A. Thom, PhD, J M. Zachary, P Mohide, MD^¶, M J. Mahoney, MD^||, J L. Simpson, MD^**, L D. Platt, MD, E Pergament, MD, PhD, D Hershey, MD, K Filkins, MD^||||, A Johnson, DO^¶¶, L P. Shulman, MD^***, J Bang, MD^*, S MacGregor, DO, J R. Smith, MD^¶, D Shaw, MB, R J. Wapner, MD and L G. Jackson, MD the NICHD EATA Trial Group^*

From the *Rigshospitalet, Copenhagen, Denmark; Evanston Hospital of Northwestern University Medical School, Evanston, Illinois; BC Women's Hospital, Vancouver, BC; The Biostatistics Center, George Washington University, Rockville, Maryland; ¶McMaster University Medical Centre, Hamilton, Ontario; ||Yale University, New Haven, Connecticut; **Baylor College of Medicine, Houston, Texas; Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, California; Department of Obstetrics and Gynecology, Northwestern University Medical School, Chicago, Illinois; Prenatal Diagnosis of Northern California Medical Group, Sacramento, California; ¶¶UCLA Center for the Health Sciences, Los Angeles, California; ||||Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan; ***University of Tennessee, Memphis, Tennessee; and Drexel University College of Medicine, Philadelphia, Pennsylvania.

Address reprint requests to: Laird Jackson, MD, Drexel University College of Medicine, Department of Obstetrics and Gynecology, Drexel University College of Medicine, Philadelphia, PA 19129; e-mail: lgj25{at}drexel.edu.

OBJECTIVE: To assess, in a randomized trial, the safety and accuracy of amniocentesis and transabdominal chorionic villus sampling (CVS) performed at 11–14 weeks of gestation, given that this time frame is increasingly relevant to early trisomy screening.

METHODS: We compared amniocentesis with CVS from 77 to 104 days of gestation in a randomized trial in a predominantly advanced maternal age population. Before randomization, the feasibility of both procedures was confirmed by ultrasonography, and experienced operators performed sampling under ultrasound guidance; conventional cytogenetic analysis was employed. The primary outcome measure was a composite of fetal loss plus preterm delivery before 28 weeks of gestation in cytogenetically normal pregnancies.

RESULTS: We randomized 3,775 women into 2 groups (1,914 to CVS; 1,861 to amniocentesis), which were comparable at baseline. More than 99.6% had the assigned procedure, and 99.9% were followed through delivery. In contrast to previous thinking, in the cytogenetically normal cohort (n = 3,698), no difference in primary study outcome was observed: 2.1% (95% confidence interval 1.5, 2.8) for CVS and 2.3% (95% confidence interval, 1.7, 3.1) for amniocentesis. However, spontaneous losses before 20 weeks and procedure-related, indicated terminations combined were increased in the amniocentesis group (P = .07, relative risk 1.74). We found a 4-fold increase in the rate of talipes equinovarus after amniocentesis (P = .02) overall and in week 13 (P = .03, relative risk = 4.65), but data were insufficient to determine this risk in week 14.

CONCLUSION: Amniocentesis at 13 weeks carries a significantly increased risk of talipes equinovarus compared with CVS and also suggests an increase in early, unintended pregnancy loss.

LEVEL OF EVIDENCE: I

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