| Objective:The aim of our study was to assess whether the use of levothyroxine was beneficial in pregnancy women with subclinical hypothyroidism or TPOAb~+Methods:This was a prospective cohort study involving1845 populations of pregnant women who attended the Clinical Reproductive Center of the Second Affiliated Hospital of Soochow University or the Kunshan Maternal and Child Health Care Center between October 1,2015 and December 31,2017.Our study was conducted into two groups[825normal pregnancy women,609 pregnancy women with a history of recurrent pregnancy loss(RPL)],each group was divided into subclinical hypothyroidism(SCH)group and TPOAb positive group:Normal Pregnancy Group(NP):Normal pregnant womenrecruited in the study RPL Pregnancy Group(RPL-P):Pregnant women who had a history of recurrent pregnancy loss recruited in the study NP and RPL-P group were divided into SCH group and TPOAb positive group respectively,the details are as follows:NP-SCHGroup:Normal pregnant women who were negative for TPOAb and have TSH concentrations greater than 2.5?IU/mL and below 10.0?IU/mL in the first trimester NP-TPOAb~+Group:Normal pregnant women who were positive for TPOAb and have normal TSH reference range in the first trimester RPL-P-SCHGroup:RPL pregnant women who were negative for TPOAb and have TSH concentrations greater than 2.5?IU/mL and below 10.0?IU/mL in the first trimester RPL-P-TPOAb~+Group:RPL pregnant women who were positive for TPOAb and have normal TSH reference range in the first trimester The patients of four groups were randomized into either the L-T4 treatment group or control group.Results:1.A total of 1434 patients were enrolled in the study according to inclusion and exclusion criteria in 1845 pregnant women.825 patients were consisted in NP group,age was 28.56±3.16 years and serum TSH value was 1.98+2.22?IU/mL.The preverence of SCH was 26.3%,and TPOAb~+was 8.6%in NP group.609 patients were consisted in RPL-P group,age was 29.12±3.73 years and serum TSH value was 2.04±1.35 IU/m L.The preverence of SCH was 27.8%,and TPOAb~+was9%in RPL-P group.Patients in NP group were younger than those in RPL-P group,and the difference between the two groups was statistically significant(p=0.030).There was no significant difference between the two groups in the preverence of SCHand TPOAb~+(P>0.05).2.InNP group,there were 825 pregnant women,686 were live births and the live births rate was 83.2%.InRPL-P group,there were 609 pregnant women,418 were live births and the live births rate was 68.6%.The live births rate of NP group was significantly higher than that of RPL-P group,the difference was statistically significant(p<0.001);Two groups of patients who were pregnancy loss,81 were in NP group,the pregnancy loss rate was 9.8%,165 were in RPL-P group,the pregnancy loss rate was 27.1%.The pregnancy loss rate in NP group was significantly lower than that of RPL-P group,and the difference was statistically significant(p<0.001);Since obstetric complications in pregnancy,the preverence of premature birthand gestationai hypertension in NP group were lower than that in RPL-P group,and the difference was statistically significant(NP group to RPL-P group:5.5%vs 13.9%,p<0.001;2.5%vs 4.6%,p=0.034);In NP group,242 pregnant women underwent caesarean section,the cesarean section rate was 35.3%and in RPL-P group were 237,the cesarean section rate was 56.7%.NP group cesarean section rate was lower than RPL-P group,the difference was statistically significant(p<0.001).3.There were 217 patientsin NP-SCHgroup,107 werein L-T4 treatment group and110 were in control group,68 and 71 were live birth,the live birth rate were 63.6%and64.5%,24 and 20 werepregnancy loss,the pregnancy loss rate were 22.4%and20.0%,respectively.There was no significant difference between the treatment group and control group in the rate of live birth and the pregnancy loss rate(P>0.05);There were 71 patientsin NP-TPOAb~+group,36 werein L-T4 treatment group and 35 were in control group,30 and 32 were live birth,the live birth rate were 83.3%and 91.4%,4 and2 werepregnancy loss,the pregnancy loss rate were 11.1%and 5.7%,respectively.There was no significant difference between the treatment group and control group in the rate of live birth and the pregnancy loss rate(P>0.05).4.There were 169 patientsin RPL-P-SCHgroup,82 werein L-T4 treatment group and87 were in control group,56 and 34 were live birth,the live birth rate were 68.3%and39.1%,20 and 47 werepregnancy loss,the pregnancy loss rate were 24.4%and54.0%,respectively.TheL-T4 treatment group had higher live births rate and lower pregnancy loss ratecompared to control group,the difference was statistically significant(p<0.001);There were 55 patientsin RPL-P-TPOAb~+group,27 werein L-T4 treatment group and 28 were in control group,25 and 19 were live birth,the live birth rate were 92.6%and 67.9%,1 and 9werepregnancy loss,the pregnancy loss rate were 3.7%and32.1%,respectively.TheL-T4 treatment group had higher live births rate and lower pregnancy loss ratecompared to control group,the difference was statistically significant(p<0.001);Conclusions:1.There was no significant difference between the normal pregnant women and the pregnant women who had a history of recurrent pregnancy lossin the preverence of SCHand TPOAb~+.2.Treatmentwith L-T4 decrease the risk of the pregnancy loss and increase the rate of live births in RPL pregnant women who were positive for TPOAb or subclinical hypothyroidism.Levothyroxine therapy is recommended for TPO antibody negative RPL women with TSH concentrations greater than the pregnancy specific reference range and below 10.0 uIU/m L and TPO antibody positive RPL women with a normal TSH.3.The replacement therapy with L-T4 was no beneficial in normal pregnant women who were TPOAb~+or SCH.Larger randomized clinical trials with TSH-based stratification should be conducted in various geographic regions to confirm whether the serumTSH levels of the pregnancy specific reference range should be upgraded. |
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