Ellish N J, Saboda K, O'Connor J, Nasca P C, Stanek E J, Boyle C
Division of Epidemiology, New York State Department of Health, Albany 12237, USA.
Hum Reprod. 1996 Feb;11(2):406-12. doi: 10.1093/humrep/11.2.406.
The New York State Early Pregnancy Detection Study was a prospective study of early pregnancy loss, between implantation and menses, in 217 women attempting to become pregnant during 1989-1992. Women collected urine samples on three consecutive mornings during the late luteal phase of their menstrual cycle, for up to 12 cycles, contributing samples for 1253 menstrual cycles. Urinary human chorionic gonadotrophin (HCG), measured using an immunoradiometric assay, was the biomarker for pregnancy. We observed a range of early pregnancy loss (EPL) rates, from a low estimate of 11.0% to a high estimate of 26.9%, depending on the definition used and the subgroup analysed. Based on a definition of 3 days of HCG concentration > or = 4.00 pmol/l, 2 days > or = 5.33 pmol/l or the last day of HCG > or = 6.67 pmol/l, we identified 115 positive cycles; 95 cycles were clinically confirmed pregnancies and 20 cycles were EPL, giving an EPL rate of 17.4% [95% confidence interval (CI) 11.0-25.6]. In addition, we observed an EPL rate of 19.5% (95% CI 11.3-30.1) for samples collected within a 15 day window around menses, and a rate of 20.3% (95% CI 11.3-32.2) for samples limited to the first three menstrual cycles. Because studies use urine collection schemes other than daily sampling, the definition of pregnancy will be crucial in defining EPL.
纽约州早期妊娠检测研究是一项关于1989年至1992年间217名试图怀孕的女性在着床至月经期间早期妊娠丢失情况的前瞻性研究。女性在月经周期黄体晚期连续三个早晨收集尿液样本，最长达12个周期，共提供了1253个月经周期的样本。使用免疫放射分析测定的尿人绒毛膜促性腺激素（HCG）是妊娠的生物标志物。根据所使用的定义和分析的亚组不同，我们观察到早期妊娠丢失（EPL）率的范围较广，低估计值为11.0%，高估计值为26.9%。基于HCG浓度≥4.00 pmol/l持续3天、≥5.33 pmol/l持续2天或HCG最后一天≥6.67 pmol/l的定义，我们确定了115个阳性周期；95个周期为临床确诊妊娠，20个周期为EPL，EPL率为17.4%[95%置信区间（CI）11.0 - 25.6]。此外，我们观察到在月经前后15天窗口内收集的样本的EPL率为19.5%（95% CI 11.3 - 30.1），限于前三个月经周期的样本的EPL率为20.3%（95% CI 11.3 - 32.2）。由于研究使用的是除每日采样以外的尿液收集方案，妊娠的定义对于定义EPL至关重要。
