PregnancyNCT02555332
Maternal Thyroid Function in Early Pregnancy and Their Relationship With Gestational Diabetes Mellitus
An observational study of Pregnancy and Thyroid Function Tests, run by Shanghai First Maternity and Infant Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnancy, Thyroid Function Tests, Gestational Diabetes Mellitus
- What is being tested?
- 75g oral glucose tolerance test (OGTT)
- Type of treatment
- Pill or oral medicine
- How many people
- 7,729 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- ≤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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Being tested
- 75g oral glucose tolerance test (OGTT)
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
75g oral glucose tolerance test (OGTT)Other
All these women underwent the 75g oral glucose tolerance test (OGTT) at 24-28 weeks of gestation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 75g oral glucose tolerance test (OGTT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
75g oral glucose tolerance test (OGTT) positive or not
Measured: 24-28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study startDec 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,729 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Ying, Shanghai First Maternity and Infant Hospital
- Investigators
- Hao Ying, PHD, Principal investigator, Shanghai First Maternity and Infant Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555332
- Sponsor's protocol ID
- REB#12-054
- Status last verified
- Sep 2015
- First submitted
- 17 Sep 2015
- Last updated
- 21 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16785147Pascual 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.
PubMed 24680382Tudela 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.
PubMed 22525909Olivieri 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.
PubMed 11124856Karakosta 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.
PubMed 23015651
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal TSH Level and TPOAb Status in Early Pregnancy and Their Relationship to the Risk of Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02555332
- Acronym / sponsor ID
- REB#12-054
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,729 participants (actual)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 21 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women underwent screening for thyroid function | – | Other: 75g oral glucose tolerance test (OGTT)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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- ≤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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 75g oral glucose tolerance test (OGTT)All these women underwent the 75g oral glucose tolerance test (OGTT) at 24-28 weeks of gestation. | Other | Women underwent screening for thyroid function |
Primary outcome
75g oral glucose tolerance test (OGTT) positive or not
Time frame: 24-28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2015.
- Results publication: PubMed 16785147Agarwal 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.
- Results publication: PubMed 24680382Pascual 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.
- Results publication: PubMed 22525909Tudela 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.
- Results publication: PubMed 11124856Olivieri 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.
- Results publication: PubMed 23015651Karakosta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Ying, PHD principal investigator
Shanghai First Maternity and Infant Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Thyroid Function Tests, run by Shanghai First Maternity and Infant Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
75g oral glucose tolerance test (OGTT) positive or not (time frame: 24-28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02555332, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2015.