经宫颈与经腹绒毛取样的随机对照研究。美国国立儿童健康与人类发展研究所绒毛取样与羊膜穿刺术研究组。

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.

作者信息

Jackson L G, Zachary J M, Fowler S E, Desnick R J, Golbus M S, Ledbetter D H, Mahoney M J, Pergament E, Simpson J L, Black S

机构信息

Division of Medical Genetics, Jefferson Medical College, Philadelphia, PA 19107.

出版信息

N Engl J Med. 1992 Aug 27;327(9):594-8. doi: 10.1056/NEJM199208273270903.

DOI:10.1056/NEJM199208273270903

PMID:1640952

Abstract

BACKGROUND

Chorionic-villus sampling is done in early pregnancy to obtain fetal cells for the prenatal diagnosis of genetic and chromosomal defects. Transcervical chorionic-villus sampling has been shown to be safe and effective in national trials. Recently, an alternative transabdominal technique has been suggested as potentially easier and safer.

METHODS

From April 1987 through September 1989, we prospectively compared transcervical and transabdominal chorionic-villus sampling in 3999 women with singleton pregnancies in whom the risk of a genetically abnormal fetus was increased. Women between 7 and 12 weeks of gestation underwent ultrasonographic evaluation of placental and uterine position. Those with active vaginal infections, active bleeding, or cervical polyps were excluded. If the obstetrician thought either sampling procedure was acceptable, the woman was asked to consent to random assignment to one of the two procedures. Both groups were followed to determine the outcome of pregnancy and the rate of spontaneous fetal loss after chorionic-villus sampling.

RESULTS

Among the 3999 women who entered the study, sampling was attempted in 3873 (97 percent), 1944 of whom had been assigned to undergo transcervical sampling and 1929 to undergo transabdominal sampling. Of these 3873 women, sampling was eventually successful in 3863. Sampling was successful after a single insertion of the sampling instrument in 94 percent of the transabdominal procedures and 90 percent of the transcervical procedures. Among the women with cytogenetically normal pregnancies who had sampling because of maternal age, the rate of spontaneous fetal loss through 28 weeks of pregnancy was 2.5 percent in the transcervical-sampling group and 2.3 percent in the transabdominal-sampling group (difference, 0.26 percent; 95 percent confidence interval, -0.5 to 1.0 percent).

CONCLUSIONS

Transabdominal and transcervical chorionic-villus sampling appear to be equally safe procedures for first-trimester diagnosis of fetal abnormalities.

摘要

背景

绒毛取样在妊娠早期进行，以获取胎儿细胞用于产前诊断遗传和染色体缺陷。经宫颈绒毛取样在全国性试验中已被证明是安全有效的。最近，一种替代的经腹技术被认为可能更容易且更安全。

方法

从1987年4月至1989年9月，我们对3999名单胎妊娠且胎儿发生基因异常风险增加的妇女，前瞻性地比较了经宫颈和经腹绒毛取样。妊娠7至12周的妇女接受胎盘和子宫位置的超声评估。排除有活动性阴道感染、活动性出血或宫颈息肉的妇女。如果产科医生认为两种取样方法均可接受，则要求该妇女同意随机分配至两种方法之一。对两组进行随访，以确定妊娠结局及绒毛取样后胎儿自然丢失率。

结果

在3999名进入研究的妇女中，3873名（97%）尝试了取样，其中1944名被分配接受经宫颈取样，1929名接受经腹取样。在这3873名妇女中，最终3863名取样成功。经腹取样94%、经宫颈取样90%在取样器械单次插入后取样成功。在因母亲年龄而进行取样的细胞遗传学正常妊娠妇女中，经宫颈取样组至妊娠28周时胎儿自然丢失率为2.5%，经腹取样组为2.3%（差异为0.26%；95%置信区间为-0.5%至1.0%）。