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

Shanghai First Maternity and Infant Hospital

Status: Completed

Conditions: Thyroid Function Tests; Gestational Diabetes Mellitus; Pregnancy

Treatments: Other: 75g oral glucose tolerance test (OGTT)

Study type: Observational

Funder types: Other

Identifiers

NCT02555332

REB#12-054

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,729 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

7,729 participants in 1 patient group

Women underwent screening for thyroid function

Description:

All these women underwent screening for thyroid function (TSH,FT4,TPOAb) at the first antenatal visit and the 75g oral glucose tolerance test (OGTT) at 24-28 weeks of gestation. The correlation between the combination of TSH level and TPOAb status and the risk of Gestational Diabetes Mellitus was analyzed.

Treatment:

Other: 75g oral glucose tolerance test (OGTT)