[Comparison of the effect of different diagnostic criteria of subclinical hypothyroidism and positive TPO-Ab on pregnancy outcomes].

OBJECTIVE: To explore the effect of different diagnositic criteria of subclinical hypothyroidism using thyroid stimulating hormone (TSH) and positive thyroid peroxidase antibodies (TPO-Ab) on the pregnancy outcomes.

METHODS: 3 244 pregnant women who had their antenatal care and delivered in Child and Maternity Health Hospital of Shannxi Province August from 2011 to February 2013 were recruited prospectively. According to the standard of American Thyroid Association (ATA), pregnant women with normal serum free thyroxine (FT4) whose serum TSH level> 2.50 mU/L were diagnosed as subclinical hypothyroidism in pregnancy (foreign standard group). According to the Guideline of Diagnosis and Therapy of Prenatal and Postpartum Thyroid Disease made by Chinese Society of Endocrinology and Chinese Society of Perinatal Medicine in 2012, pregnant women with serum TSH level> 5.76 mU/L, and normal FT4 were diagnosed as subclinical hypothyroidism in pregnancy(national standard group). Pregnant women with subclinical hypothyroidism whose serum TSH levels were between 2.50-5.76 mU/L were referred as the study observed group; and pregnant women with serum TSH level< 2.50 mU/L and negative TPO- Ab were referred as the control group. Positive TPO-Ab results and the pregnancy outcomes were analyzed.

RESULTS: (1) There were 635 cases in the foreign standard group, with the incidence of 19.57% (635/3 244). And there were 70 cases in the national standard group, with the incidence of 2.16% (70/3 244). There were statistically significant difference between the two groups (P < 0.01). There were 565 cases in the study observed group, with the incidence of 17.42% (565/3 244). There was statistically significant difference (P < 0.01) when compared with the national standard group; while there was no statistically significant difference (P > 0.05) when compared with the foreign standard group. (2) Among the 3 244 cases, 402 cases had positive TPO-Ab. 318 positive cases were in the foreign standard group, and the incidence of subclinical hypothyroidism was 79.10% (318/402). There were 317 negative cases in the foreign standard group, with the incidence of 11.15% (317/2 842). The difference was statistically significant (P < 0.01) between them. In the national standard group, 46 cases had positive TPO-Ab, with the incidence of 11.44% (46/402), and 24 cases had negative result, with the incidence of 0.84% (24/2 842). There were statistically significant difference (P < 0.01) between them. In the study observed group, 272 cases were TPO-Ab positive, with the incidence of 67.66% (272/402), and 293 cases were negative, with the incidence of 10.31% (293/2 842), the difference was statistically significant (P < 0.01). (3) The incidence of miscarriage, premature delivery, gestational hypertension disease, gestational diabetes mellitus(GDM)in the foreign standard group had statistically significant differences (P < 0.05) when compared with the control group, respectively. While there was no statistically significant difference (P > 0.05) in the incidence of placental abruption or fetal distress. And the incidence of miscarriage, premature delivery, gestational hypertension disease, GDM in the national standard group had statistical significant difference (P < 0.05) compared with the control group, respectively. While there was no statistically significant difference (P > 0.05) in the incidence of placental abruption or fetal distress. This study observed group of pregnant women's abortion, gestational hypertension disease, GDM incidence respectively compared with control group, the difference had statistical significance (P < 0.05); but in preterm labor, placental abruption, and fetal distress incidence, there were no statistically significant difference (P > 0.05). (4) The incidence of miscarriage, premature delivery, gestational hypertension disease, GDM, placental abruption, fetal distress in the TPO-Ab positive cases of the national standard group showed an increase trend when compared with TPO-Ab negative cases, with no statistically significant difference (P > 0.05). The incidence of gestational hypertension disease and GDM in the TPO-Ab positive cases of the study observed group had statistical significance difference (P < 0.05) when compared with TPO-Ab negative cases; while the incidence of miscarriage, premature birth, placental abruption, fetal distress had no statistically significant difference (P > 0.05). The incidence of gestational hypertension disease and GDM in the TPO-Ab positive cases had statistically significance difference when compared with TPO-Ab negtive cases of foreign standard group (P < 0.05).

CONCLUSIONS: (1) The incidence of subclinical hypothyroidism is rather high during early pregnancy and can lead to adverse pregnancy outcome. (2) Positive TPO-Ab result has important predictive value of the thyroid dysfunction and GDM. (3) Relatively, the ATA standard of diagnosis (serum TSH level> 2.50 mU/L) is safer for the antenatal care; the national standard (serum TSH level> 5.76 mU/L) is not conducive to pregnancy management.