The Establish of Specific Reference Ranges for Thyroid Tests in Pregnant Women
August 11, 2020 updated by: Xiaomei Zhang
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Beijing
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Beijing, Beijing, China, 102206
- Recruiting
- Peking University International Hospital
-
Contact:
- Xiaomei Zhang, Director
- Phone Number: 6900 6260
- Email: yuanning00076@126.com
-
Contact:
- Ning Yuan
- Phone Number: 010 6900 6260
- Email: yuanning@pkuih.edu.cn
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Changping, Beijing, China, 102206
- Recruiting
- Peking University International Hospital
-
Contact:
- Xiaomei Zhang, Director
- Phone Number: 6900 6294
- Email: yuanning00076@126.com
-
-
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
19 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The influence of thyroid disorders on pregnancy.
Time Frame: up to 2 years
|
Pregnant women:subclinical hypothyroidism,hypertension of pregnancy, eclampsia gravidarum, gestational diabetes mellitus, abortion, stillbirth.
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up to 2 years
|
|
The influence of thyroid disorders its outcomes.
Time Frame: up to 2 years
|
Newborn:neonatal death,neonatal respiratory distress syndrome, low birth weight, macrosomia,et al.
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Xiao M zhang, Chief, Peking University International 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
- Zhang 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.
- Yuan 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.
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 (Actual)
December 1, 2016
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
October 24, 2016
First Submitted That Met QC Criteria
November 14, 2016
First Posted (Estimate)
November 17, 2016
Study Record Updates
Last Update Posted (Actual)
August 13, 2020
Last Update Submitted That Met QC Criteria
August 11, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PekingUIH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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