Database - (CIANE)

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Created on : 27 Jul 2004
Modified on : 27 Dec 2007

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Bibliographical entry (without author) :

Late first-trimester invasive prenatal diagnosis: results of an international randomized trial. Obstet Gynecol. 2004 Jun;103(6):1164-73.

Author(s) :

Philip J, Silver RK, Wilson RD, Thom EA, et al.

Year of publication :

2004

URL(s) :

http://www.greenjournal.org/cgi/content/abstract/1…

Résumé (français)  :

Abstract (English)  :

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

Sumário (português)  :

Resumen (español)  :

Comments :

Argument (français) :

L’amniocentèse pendant le 1er trimestre de grossesse entraîne un risque de pied bot 4 fois plus élevé que le prélèvement des villosités choriales.

Argument (English):

Argumento (português):

Argumento (español):

Keywords :

➡ evidence-based medicine/midwifery ; amniocentesis ; screening ; stillbirth ; maternal age ; trisomy

Author of this record :

Cécile Loup — 27 Jul 2004