| ObjectiveTo explore the clinical value of measuring the ratio of human chorionic gonadotropin and hCG related protein (i-hCG?hCGRP) in the urine of the early pregnancy women only one time in the prediction of the pregnancy outcome of threatened abortion.MethodsA total of 107 women with threatened abortion (threatened abortion group), 122 women with normal intrauterine pregnancies (normal control group) were eligible for the study between July 2009 to June 2010 in Jinan women and children's hospital. The threatened abortion cases had clear last menstrual periods with 5～7 gestational week and intrauterine pregnancy confirmed by type B ultrasonic. The cases whose bleeding was caused by lesions of vulva, vagina or cervix were excluded. The 122 cases of normal early pregnancy women who wondered to know the long-dated survivability of the embyos in advance also had clear last menstrual periods with 5～7 gestational week. The two groups had no habitual abortions previously or chemicals and radiation exposure or familial history of hereditary diseases. The patients age was at 21～35 years old and had no serious heart, kidneys, liver, blood and endocrine diseases or merger cervical dysfunctional, multiple pregnancies, ovarian tumor and through assisted reproductive technologies pregnancies. Patients had to be informed consent. The patient's name, age, the history of pregnancies and labors, history of spontaneous abortion, the contact method and other basic situations were detailed recorded. Took 5ml clean medistream urine under room temperature to determine the ratio of i-hCG?hCGRP through double antibody sandwich enzyme-linked immuno sorbent assay( ELISA) by the InExscreen immuosorbent. There were printed color ladder intensities in it to contrast A and B two windows through the colorimetric method within two test line T of strong degree (0 ~ 10 scale). When the color of the C test line appeared both in A and B windows without the appearance of the T test line, noted for negative result; when the color of the T test line in A window was lighter than it in B window or two windows colour-displayed similar(namely A≤B), noted for positive 1; when the color of the T test line in A window was deeper than it in B window(namely A>B), noted for positive 2. At the same time we could also speculate the content of urine i-hCG based on A window test intensity (1 ~ 5 level, half quantitative method) to assist clinical diagnosis and record results. All the cases were informed to take regular antenatal examination. We followed up pregnancy outcomes through the outpatient appointment, telephoned and the information retrieval of the hospitalized patients, and recorded the pregnancy complications, labor gestational age, delivery methods and birth weight and other information.The experimental data statistics was evaluated by SPSS13.0 statistical software package, P< 0.05 for difference was statistically significant.Results1. Effective cases and general information of the two groupsThere were 107 cases in threatened abortion group, 101 effective cases were available for analysis due to 6 cases lost to follow-up. There were 122 cases in normal control group, 108 effective cases were available for analysis due to 14 cases lost to follow-up. There were no statistical significant differences between the two groups as regards the age, gravidity and parity (P>0.05), which were comparable.2. Result of i-hCG?hCGRPThe cases of positive 2 and positive 1 were 36 and 65 in the threatened abortion group separately and the positive 2 ratios were 35.64%. The cases of positive 2 and positive 1 were 16 and 92 in the normal control group separately and the positive 2 ratios were 14.81%. There was statistical significance between the two groups (P<0.05). The distribution of level 1～4 of the content of urine i-hCG was 6, 34, 59, 2 in threatened abortion group and 0, 29, 69, 10 in the normal control group respectively. The content of urine i-hCG was lower in threatened abortion group than that in the normal control group. There were significant differences between the two groups (P<0.05).3. Pregnancy outcomes21 cases were pregnancy loss in the threatened abortion group and no one in the normal control group. The abortion rate (20.79%) was higher in the threatened abortion group than that in the normal control group. There were 2 cases of premature delivery, 1 case of preeclamia, 3 cases of placental abruption and 74 cases of full-term normal delivery of 80 cases of the threatened abortion-ongoing pregnancy group. There were 15 cases undergone inevitable abortion 5 days to 5 weeks after seeing the doctor, and 6 cases undergone missed abortion of 21 cases in the threatened abortion-pregnancy loss group. There were 5 cases of premature delivery, 7 cases of preeclamia, 1 case of placental abruption and 95 cases of full-term normal delivery of 108 cases in the normal control group. There were no significant differences between the threatened abortion-ongoing pregnancy group and the normal control group as regards the pregnancy outcome of premature delivery, preeclamia, placental abruption and full-term normal delivery (P>0.05).4. The relationship between the i-hCG?hCGRP result and the pregnancy outcomeThe result of positive 2 can predict pregnancy loss with a diagnosis index of 181.25% (sensitivity 100%, specificity 81.25%), Youden′s index of 0.8125, negative predictive value of 100% and positive predictive value of 58.33%.ConclusionMeasuring the ratio of i-hCG?hCGRP in the urine only one time between 5～7 gestational week can predict the pregnancy outcome of the threatened abortion more accurately. The result of positive 2 can predict pregnancy loss with a diagnosis index of 181.25% (sensitivity 100%, specificity 81.25%), Youden′s index of 0.8125, negative predictive value of 100% and positive predictive value of 58.33%. Pregnancy will be successful if the i-hCG?hCGRP result is positive 1 without the affection of random urine, but the morning urine testing may be more helpful to estimate the outcome of threatened abortion if the i-hCG?hCGRP result is positive 2 because the level of i-hCG may be lower in the diluting urine. |
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