Diseases Pregnancy ThyroidNCT02966405
The Establish of Specific Reference Ranges for Thyroid Tests in Pregnant Women
An observational study of Diseases Pregnancy Thyroid, run by Xiaomei Zhang at 2 sites in China.
Trial summary
A descriptive analysis involving 300 healthy pregnant women to the establish of trimester-specific reference ranges for thyroid tests in pregnant women. 700 cases were selected as the normal pregnant population to establish a self-sequential longitudinal reference range. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diseases Pregnancy Thyroid
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2016to Dec 2020
- How long will I take part?
- 2 Years
- 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 19 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: A descriptive analysis involving 300 healthy pregnant women according NACB to the establish of trimester-specific reference ranges for thyroid tests in pregnant women. According to the selection criteria, 700 cases were selected as the normal pregnant population to establish a self-sequential longitudinal reference range. The aim of this study to monitor the change of thyroid function and antibody during the course of pregnancy in those who suffer from various thyroid disorders and normal control.
Who may be able to join
- The people who lived in the city more than five years, aged between 19 and 45, or the single pregnancy women who registered or checked in Peking University international hospital would be enrolled.
- The pregnancy confirmed by the ultrasound or blood HCG test.
- In order to build a pregnancy reference range of normal pregnant women who must meet the NACB standard.
Who cannot join
- The history of thyroid disorders.
- Goiter.
- Oral contraceptives or any drugs affected the function of thyroid.
- With other chronic autoimmune disease, malignant tumor, blood disease, etc
- Twin pregnancies and multiple pregnancies
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Peking University International Hospital
Beijing, Beijing Municipality, 102206
Xiaomei Zhang, Director, 6900 6260, yuanning00076@126.com
Ning Yuan, 010 6900 6260, yuanning@pkuih.edu.cn
- Recruiting
Peking University International Hospital
Changping, Beijing Municipality, 102206
Xiaomei Zhang, Director, 6900 6294, yuanning00076@126.com
About this study
Official title: The Establish of Trimester-specific Reference Ranges for Thyroid Tests in Pregnant Women and the Influence of Thyroid Disorders on Pregnancy and Its Outcomes.
A descriptive analysis involving 300 healthy pregnant women to the establish of trimester-specific reference ranges for thyroid tests in pregnant women. 700 cases were selected as the normal pregnant population to establish a self-sequential longitudinal reference range.
Read the detailed description
A descriptive analysis involving 300 healthy pregnant women according NACB to the establish of trimester-specific reference ranges for thyroid tests in pregnant women. According to the selection criteria, 700 cases were selected as the normal pregnant population to establish a self-sequential longitudinal reference range. The aim of this study to monitor the change of thyroid function and antibody during the course of pregnancy in those who suffer from various thyroid disorders and normal control.
- Conditions
- Diseases Pregnancy Thyroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy pregnant women | A descriptive analysis involving 300 healthy pregnant women according NACB to the establish of trimester-specific reference ranges for thyroid tests in pregnant women. | |
| Normal pregnant population | According to the selection criteria, 700 cases were selected as the normal pregnant population to establish a self-sequential longitudinal reference range. The aim of this study to monitor the change of thyroid function and antibody during the course of pregnancy in those who suffer from various thyroid disorders and normal control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection the FT3,FT4,TSH,TPOAb of the pregnant women in trimester of pregnancy.
Detection the FT3,FT4,TSH,TPOAb of the pregnant women in trimester of pregnancy.
Measured: up to 2 years
Secondary outcomes (2)
The influence of thyroid disorders on pregnancy.
Pregnant women:subclinical hypothyroidism,hypertension of pregnancy, eclampsia gravidarum, gestational diabetes mellitus, abortion, stillbirth.
Measured: up to 2 years
The influence of thyroid disorders its outcomes.
Newborn:neonatal death,neonatal respiratory distress syndrome, low birth weight, macrosomia,et al.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diseases Pregnancy ThyroidStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Xiaomei Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaomei Zhang, Peking University International Hospital
- Investigators
- Xiao M zhang, Chief, Study chair, Peking University International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966405
- Sponsor's protocol ID
- PekingUIH
- Status last verified
- Aug 2020
- First submitted
- 24 Oct 2016
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Zhao D, Chai S, Yuan N, Sun J, Zhao X, Zhang X. Triglyceride-glycaemic index: Insights into predicting fetal macrosomia and its interaction with gestational diabetes mellitus: A cohort study of Chinese pregnant women. Eur J Clin Invest. 2024 Dec;54(12):e14300. doi: 10.1111/eci.14300. Epub 2024 Aug 13.
PubMed 39136403Zhang X, Yuan N, Sun J, Zhao X, Du J, Nan M, Zhang Q, Ji L. Association Between Iodine Nutritional Status and Adverse Pregnancy Outcomes in Beijing, China: a Single-Center Cohort Study. Biol Trace Elem Res. 2022 Jun;200(6):2620-2628. doi: 10.1007/s12011-021-02887-9. Epub 2021 Sep 27.
PubMed 34570342Yuan N, Sun J, Li Z, Chai S, Zhang X, Ji L. Relationship between anti-thyroid peroxidase antibody positivity and pregnancy-related and fetal outcomes in Euthyroid women: a single-center cohort study. BMC Pregnancy Childbirth. 2020 Aug 26;20(1):491. doi: 10.1186/s12884-020-03176-4.
PubMed 32847542
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Establish of Trimester-specific Reference Ranges for Thyroid Tests in Pregnant Women and the Influence of Thyroid Disorders on Pregnancy and Its Outcomes.
- ClinicalTrials.gov ID
- NCT02966405
- Acronym / sponsor ID
- PekingUIH
- Conditions
- Diseases Pregnancy Thyroid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xiaomei ZhangUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 Nov 2016 (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.
A descriptive analysis involving 300 healthy pregnant women to the establish of trimester-specific reference ranges for thyroid tests in pregnant women. 700 cases were selected as the normal pregnant population to establish a self-sequential longitudinal reference range.
Detailed description
A descriptive analysis involving 300 healthy pregnant women according NACB to the establish of trimester-specific reference ranges for thyroid tests in pregnant women. According to the selection criteria, 700 cases were selected as the normal pregnant population to establish a self-sequential longitudinal reference range. The aim of this study to monitor the change of thyroid function and antibody during the course of pregnancy in those who suffer from various thyroid disorders and normal control.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy pregnant women | – | –A descriptive analysis involving 300 healthy pregnant women according NACB to the establish of trimester-specific reference ranges for thyroid tests in pregnant women. |
| Normal pregnant population | – | –According to the selection criteria, 700 cases were selected as the normal pregnant population to establish a self-sequential longitudinal reference range. The aim of this study to monitor the change of thyroid function and antibody during the course of pregnancy in those who suffer from various thyroid disorders and normal control. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A descriptive analysis involving 300 healthy pregnant women according NACB to the establish of trimester-specific reference ranges for thyroid tests in pregnant women. According to the selection criteria, 700 cases were selected as the normal pregnant population to establish a self-sequential longitudinal reference range. The aim of this study to monitor the change of thyroid function and antibody during the course of pregnancy in those who suffer from various thyroid disorders and normal control.
Key inclusion criteria (3 listed)
- The people who lived in the city more than five years, aged between 19 and 45, or the single pregnancy women who registered or checked in Peking University international hospital would be enrolled.
- The pregnancy confirmed by the ultrasound or blood HCG test.
- In order to build a pregnancy reference range of normal pregnant women who must meet the NACB standard.
Key exclusion criteria (5 listed)
- The history of thyroid disorders.
- Goiter.
- Oral contraceptives or any drugs affected the function of thyroid.
- With other chronic autoimmune disease, malignant tumor, blood disease, etc
- Twin pregnancies and multiple pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection the FT3,FT4,TSH,TPOAb of the pregnant women in trimester of pregnancy.
Time frame: up to 2 years
Detection the FT3,FT4,TSH,TPOAb of the pregnant women in trimester of pregnancy.
2 secondary outcomes
The influence of thyroid disorders on pregnancy.
Time frame: up to 2 years
The influence of thyroid disorders its outcomes.
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Derived from this study: PubMed 39136403Zhao D, Chai S, Yuan N, Sun J, Zhao X, Zhang X. Triglyceride-glycaemic index: Insights into predicting fetal macrosomia and its interaction with gestational diabetes mellitus: A cohort study of Chinese pregnant women. Eur J Clin Invest. 2024 Dec;54(12):e14300. doi: 10.1111/eci.14300. Epub 2024 Aug 13.
- Derived from this study: PubMed 34570342Zhang X, Yuan N, Sun J, Zhao X, Du J, Nan M, Zhang Q, Ji L. Association Between Iodine Nutritional Status and Adverse Pregnancy Outcomes in Beijing, China: a Single-Center Cohort Study. Biol Trace Elem Res. 2022 Jun;200(6):2620-2628. doi: 10.1007/s12011-021-02887-9. Epub 2021 Sep 27.
- Derived from this study: PubMed 32847542Yuan N, Sun J, Li Z, Chai S, Zhang X, Ji L. Relationship between anti-thyroid peroxidase antibody positivity and pregnancy-related and fetal outcomes in Euthyroid women: a single-center cohort study. BMC Pregnancy Childbirth. 2020 Aug 26;20(1):491. doi: 10.1186/s12884-020-03176-4.
- Individual participant dataSharing planned: Undecided
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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.
Xiao M zhang, Chief study chair
Peking University International Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diseases Pregnancy Thyroid, run by Xiaomei Zhang at 2 sites in China.
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 3 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: status not confirmed, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao M zhang, Chief (010 69006260, yuanning00076@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection the FT3,FT4,TSH,TPOAb of the pregnant women in trimester of pregnancy. (time frame: up to 2 years). 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 NCT02966405, which also lists 3 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 13 Aug 2020.