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Completed

NCT Number: NCT02555332

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

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.

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Key information

Conditions

Pregnancy Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Thyroid Function Tests Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Criteria:

Inclusion criteria

  • ≤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.

Exclusion criteria

  • 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.

Treatment and study plan

75g oral glucose tolerance test (OGTT)

Other

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

Primary outcomes

  1. 75g oral glucose tolerance test (OGTT) positive or not

    Time frame: 24-28 weeks

Sponsors and collaborators

Lead sponsor

Shanghai First Maternity and Infant Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 21, 2015
Registry last updated
Sep 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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