Eddleman Keith A, Malone Fergal D, Sullivan Lisa, Dukes Kim, Berkowitz Richard L, Kharbutli Yara, Porter T Flint, Luthy David A, Comstock Christine H, Saade George R, Klugman Susan, Dugoff Lorraine, Craigo Sabrina D, Timor-Tritsch Ilan E, Carr Stephen R, Wolfe Honor M, D'Alton Mary E
Mount Sinai School of Medicine, New York, New York, USA.
Obstet Gynecol. 2006 Nov;108(5):1067-72. doi: 10.1097/01.AOG.0000240135.13594.07.
The purpose of this study was to quantify the contemporary procedure-related loss rate after midtrimester amniocentesis using a database generated from patients who were recruited to the First And Second Trimester Evaluation of Risk for Aneuploidy trial.
A total of 35,003 unselected patients from the general population with viable singleton pregnancies were enrolled in the First And Second Trimester Evaluation of Risk for Aneuploidy trial between 10 3/7 and 13 6/7 weeks gestation and followed up prospectively for complete pregnancy outcome information. Patients who either did (study group, n=3,096) or did not (control group, n=31,907) undergo midtrimester amniocentesis were identified from the database. The rate of fetal loss less than 24 weeks of gestation was compared between the two groups, and multiple logistic regression analysis was used to adjust for potential confounders.
The spontaneous fetal loss rate less than 24 weeks of gestation in the study group was 1.0% and was not statistically different from the background 0.94% rate seen in the control group (P=.74, 95% confidence interval -0.26%, 0.49%). The procedure-related loss rate after amniocentesis was 0.06% (1.0% minus the background rate of 0.94%). Women undergoing amniocentesis were 1.1 times more likely to have a spontaneous loss (95% confidence interval 0.7-1.5).
The procedure-related fetal loss rate after midtrimester amniocentesis performed on patients in a contemporary prospective clinical trial was 0.06%. There was no significant difference in loss rates between those undergoing amniocentesis and those not undergoing amniocentesis.
II-2.
本研究旨在利用从参与早中孕期非整倍体风险评估试验招募的患者生成的数据库,量化孕中期羊膜腔穿刺术后当代与手术相关的流产率。
共有35003名来自普通人群、怀有单活胎的未经过筛选的患者在妊娠10 3/7至13 6/7周期间参加了早中孕期非整倍体风险评估试验,并进行前瞻性随访以获取完整的妊娠结局信息。从数据库中识别出接受(研究组,n = 3096)或未接受(对照组,n = 31907)孕中期羊膜腔穿刺术的患者。比较两组妊娠24周前的胎儿丢失率,并采用多因素逻辑回归分析调整潜在混杂因素。
研究组妊娠24周前的自然流产率为1.0%,与对照组中观察到的0.94%的背景率无统计学差异(P = 0.74,95%置信区间-0.26%,0.49%)。羊膜腔穿刺术后与手术相关的流产率为0.06%(1.0%减去0.94%的背景率)。接受羊膜腔穿刺术的女性自然流产的可能性高1.1倍(95%置信区间0.7 - 1.5)。
在当代前瞻性临床试验中,对患者进行孕中期羊膜腔穿刺术后与手术相关的胎儿丢失率为0.06%。接受羊膜腔穿刺术者与未接受者的流产率无显著差异。
II - 2。