Evaluation of methods for the prospective identification of early fetal losses in environmental epidemiology studies.

A major problem in the epidemiologic investigation of early fetal losses has been incomplete or biased ascertainment. In order to assess early fetal losses more accurately, one must first develop a simple method to identify early pregnancy. This study, conducted at the University of Pittsburgh from October 1985 through October 1986, has developed such a method through the use of monoclonal antibody urine pregnancy testing kits. A total of 88 volunteers collected urine samples beginning on the seventh postovulatory day and continued until either menses occurred or a serum radioimmunoassay pregnancy test was performed on day 16. If pregnancy was diagnosed, all of the participants' urine specimens from that menstrual cycle were analyzed by five monoclonal antibody tests. A total of 34 pregnancies were diagnosed, six (18%) of which resulted in early fetal losses. Pregnancy was first detectable between eight and 18 days postovulation. The mean time to the first positive test was 14 days for all five kits. The results indicate that it is possible to diagnose early pregnancy with urine testing and that this method is likely to prove acceptable for use in large-scale prospective studies.