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

NCT02555332 | Completed

• 1 other identifier: REB#12-054
• Study Type: observational
• Target: 7,729
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy; Thyroid Function Tests; Gestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 75g oral glucose tolerance test (OGTT) positive or not

  24-28 weeks

Study Arms (1)

Women underwent screening for thyroid function

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.

Other: 75g oral glucose tolerance test (OGTT)

Interventions

75g oral glucose tolerance test (OGTT) OTHER

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

Women underwent screening for thyroid function

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All the pregnant women who were receiving antenatal care at Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine were invited to participate in the study.Informed consents were obtained from all subjects.

You may qualify if:

• ≤19+6 weeks of gestation at the first antenatal visit;
• singleton pregnancy;
• FT4 level is within the normal range;
• TSH level is normal or beyond the normal range.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead

Related 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. doi: 10.1080/09513590600630470.

  PMID: 16785147 RESULT

• Pascual Corrales E, Andrada P, Auba M, Ruiz Zambrana A, Guillen Grima F, Salvador J, Escalada J, Galofre 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.2014.01.009. Epub 2014 Mar 26. English, Spanish.

  PMID: 24680382 RESULT

• 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.

  PMID: 22525909 RESULT

• 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 Dec;143(6):741-7. doi: 10.1530/eje.0.1430741.

  PMID: 11124856 RESULT

• 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 birth outcomes. J Clin Endocrinol Metab. 2012 Dec;97(12):4464-72. doi: 10.1210/jc.2012-2540. Epub 2012 Sep 26.

  PMID: 23015651 RESULT

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Hao Ying, PHD

  Shanghai First Maternity and Infant Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director,Clinical research

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: September 21, 2015
• Study Start: December 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 21, 2015

Record last verified: 2015-09