The New York State Early Pregnancy Detection Study was a prospective s
tudy 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 pha
se 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 pr
egnancy. 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 greater than or equal to 4.00 pmol/l, 2 day
s greater than or equal to 5.33 pmol/l or the last day of HCG greater
than or equal to 6.67 pmol/l, we identified 115 positive cycles; 95 cy
cles were clinically confirmed pregnancies and 20 cycles were EPL, giv
ing an EPL, rate of 17.4% [95% confidence interval (CI) 11.0-25.6]. Tn
addition, we observed an EPL rate of 19.5% (95% CI 11.3-30.1) for sam
ples 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
.