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  • Title: Evaluation of methods for the prospective identification of early fetal losses in environmental epidemiology studies.
    Author: Sweeney AM, Meyer MR, Aarons JH, Mills JL, LaPorte RE.
    Journal: Am J Epidemiol; 1988 Apr; 127(4):843-50. PubMed ID: 3354549.
    Abstract:
    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. In order to determine the role of toxic agents in the work place or elsewhere in the environment in early fetal loss, it is necessary to be able to diagnose pregnancy within 2 weeks after ovulation. Normally, pregnancy tests are done when a woman misses her 2nd menstrual period. Early fetal loss is estimated to be about 40%, but women rarely seek medical attention for it, so there is no medical record, and it is not reported in retrospective studies due to recall bias; therefore, 3/4 of all early fetal loss is never recognized. The purpose of this study is to evaluate whether monoclonal antibody urine pregnancy testing kits are sensitive enough to detect human chorionic gonadotropin within 10 days of ovulation. 88 women, aged 20 to 38, who were trying to become pregnant, were taught cervical mucus-basal body temperature monitoring, so they could tell when ovulation occurred. 7 days later they began collecting daily urine samples. If they did not menstruate by the 16th postovulatory day, serum radioimmunoassay for the detection of the beta subunit of human chorionic gonadotropin was done. 32 women became pregnant, and their daily urine samples were analyzed using 5 monoclonal antibody urine pregnancy testing kits. 90% of the pregnancies were detected by all 5 kits by the 16th day. 6 of the pregnancies ended in early fetal loss within 90 days, 2/3 of them within 60 days. The urine testing kits all measured a sharp rise in human chorionic gonadotropin levels after the 14th postovulatory day for the women who maintained their pregnancy, but not for those who suffered the early fetal losses. Weekly, rather than daily, urine sampling would have revealed 66% of them. Thus, it is established that the monoclonal antibody urine pregnancy detection kits can diagnose pregnancy within 14 days after ovulation. Urine tests also have the advantage that they may also reveal traces of the environmental toxins. Moreover, they are economically feasible, since they cost on average $2.13 per test as opposed to $22.50 for each serum assay.
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