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

September 17, 2015 updated by: Hao Ying, Shanghai First Maternity and Infant Hospital

Maternal TSH Level and TPOAb Status in Early Pregnancy and Their Relationship to the Risk of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

7729

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai First Maternity and Infant Hospital

Investigators

  • Principal Investigator: Hao Ying, PHD, Shanghai first maternity and infant hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

September 17, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (Estimate)

September 21, 2015

Study Record Updates

Last Update Posted (Estimate)

September 21, 2015

Last Update Submitted That Met QC Criteria

September 17, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB#12-054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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