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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555332
• Other study ID #: REB#12-054
• Status: Completed
• Phase: N/A
• First received: September 17, 2015
• Last updated: September 17, 2015
• Start date: December 2012
• Est. completion date: March 2014

Study information

• Verified date: September 2015
• Source: Shanghai First Maternity and Infant Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Chinese Medical Association
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7729
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus
• Pregnancy
• Thyroid Function Tests

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital

References & Publications (5)

Agarwal MM, Dhatt GS, Punnose J, Bishawi B, Zayed R. Thyroid function abnormalities and antithyroid antibody prevalence in pregnant women at high risk for gestational diabetes mellitus. Gynecol Endocrinol. 2006 May;22(5):261-6. — View Citation

Karakosta P, Alegakis D, Georgiou V, Roumeliotaki T, Fthenou E, Vassilaki M, Boumpas D, Castanas E, Kogevinas M, Chatzi L. Thyroid dysfunction and autoantibodies in early pregnancy are associated with increased risk of gestational diabetes and adverse bir — View Citation

Olivieri A, Valensise H, Magnani F, Medda E, De Angelis S, D'Archivio M, Sorcini M, Carta S, Baccarini S, Romanini C. High frequency of antithyroid autoantibodies in pregnant women at increased risk of gestational diabetes mellitus. Eur J Endocrinol. 2000 — View Citation

Pascual Corrales E, Andrada P, Aubá M, Ruiz Zambrana A, Guillén Grima F, Salvador J, Escalada J, Galofré JC. Is autoimmune thyroid dysfunction a risk factor for gestational diabetes? Endocrinol Nutr. 2014 Aug-Sep;61(7):377-81. doi: 10.1016/j.endonu.2014.0 — View Citation

Tudela CM, Casey BM, McIntire DD, Cunningham FG. Relationship of subclinical thyroid disease to the incidence of gestational diabetes. Obstet Gynecol. 2012 May;119(5):983-8. doi: 10.1097/AOG.0b013e318250aeeb. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	75g oral glucose tolerance test (OGTT) positive or not		24-28 weeks	No