Late first-trimester invasive prenatal diagnosis: results of an international randomized trial
| Autor: | Richard K. Silver, Elizabeth Thom, Douglas W. Hershey, Ronald J. Wapner, Karen Filkins, Anthony Johnson, J. R. Smith, Jens Bang, Patrick Mohide, R. D. Wilson, Maurice J. Mahoney, Julia Zachary, J. Simpson, MacGregor Sn, Lawrence D. Platt, Laird G. Jackson, Eugene Pergament, John Philip, Lee P. Shulman, D. Shaw |
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| Rok vydání: | 2004 |
| Předmět: |
medicine.medical_specialty
Time Factors Pregnancy High-Risk Chorionic villus sampling Prenatal diagnosis Trisomy Oligohydramnios Ultrasonography Prenatal law.invention fluids and secretions Obstetric Labor Premature Randomized controlled trial law Pregnancy medicine Humans Fetal Death Fetal Growth Retardation medicine.diagnostic_test Obstetrics business.industry Pregnancy Outcome Obstetrics and Gynecology Abortion Induced equipment and supplies medicine.disease Clinical trial Abortion Spontaneous Clubfoot Pregnancy Trimester First Chorionic Villi Sampling Amniocentesis Gestation Female Safety business Follow-Up Studies Maternal Age |
| Zdroj: | Obstetrics and gynecology. 103(6) |
| ISSN: | 0029-7844 |
| Popis: | 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.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.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.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.I |
| Databáze: | OpenAIRE |
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