Maternal Thyroid Function in Early Pregnancy and Their Relationship With Gestational Diabetes Mellitus

Maternal TSH Level and TPOAb Status in Early Pregnancy and Their Relationship to the Risk of Gestational Diabetes Mellitus

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02555332

Enrollment

7729

Registered

2015-09-21

Start date

2012-12-31

Completion date

2014-03-31

Last updated

2015-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus, Pregnancy, Thyroid Function Tests

Brief summary

This study was conducted to analyze the role of TSH level and TPOAb status in early pregnancy and use this information in assessment of the risk of gestational diabetes mellitus at different weeks of gestation when the FT4 level is normal.

Detailed description

A total of 7,729 women with singleton pregnancies who were receiving antenatal care at Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine between December 2012 and March 2014 were included in the study. All these women underwent screening for thyroid function (TSH,FT4 and TPOAb) at the first antenatal visit and a 75 g oral glucose tolerance test at 24-28 weeks of gestation. The correlation between a combination of TSH level and TPOAb status and the risk of gestational diabetes mellitus was analyzed.

Interventions

OTHER75g oral glucose tolerance test (OGTT)

All these women underwent the 75g oral glucose tolerance test (OGTT) at 24-28 weeks of gestation.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

Criteria: Inclusion Criteria: 1. ≤19+6 weeks of gestation at the first antenatal visit; 2. singleton pregnancy; 3. FT4 level is within the normal range; 4. TSH level is normal or beyond the normal range.

Exclusion criteria

1. age \<18 years or \>40 years; 2. thyroid disease history before pregnancy, e.g. hyperthyroidism, clinical hypothyroidism and malignant tumors of the thyroid, regardless of medication treatment is needed or not; 3. twin or multiple gestations; 4. diagnosed with diabetes mellitus before pregnancy, or fasting blood-glucose level ≥ 7.0 mmol/L or HbA1C≥6.5% at the first antenatal visit; 5. diseases causing abnormal glycometabolism or severe co-morbidities or diseases causing abnormal glycometabolism.

Design outcomes

Primary

Measure	Time frame
75g oral glucose tolerance test (OGTT) positive or not	24-28 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026