The Establish of Specific Reference Ranges for Thyroid Tests in Pregnant Women

NCT ID: NCT02966405

Last Updated: 2020-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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

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Diseases Pregnancy Thyroid

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. The pregnancy confirmed by the ultrasound or blood HCG test.
3. In order to build a pregnancy reference range of normal pregnant women who must meet the NACB standard.

Exclusion Criteria

1. The history of thyroid disorders.
2. Goiter.
3. Oral contraceptives or any drugs affected the function of thyroid.
4. With other chronic autoimmune disease, malignant tumor, blood disease, etc
5. Twin pregnancies and multiple pregnancies
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Xiaomei Zhang

OTHER

Sponsor Role lead

Responsible Party

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Xiaomei Zhang

Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xiao M zhang, Chief

Role: STUDY_CHAIR

Peking University International Hospital

Locations

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Peking University International Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking University International Hospital

Changping, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiao M zhang, Chief

Role: CONTACT

010 69006260

Facility Contacts

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Xiaomei Zhang, Director

Role: primary

6900 6260

Ning Yuan

Role: backup

010 6900 6260

Xiaomei Zhang, Director

Role: primary

6900 6294

References

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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.

Reference Type DERIVED
PMID: 39136403 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34570342 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32847542 (View on PubMed)

Other Identifiers

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PekingUIH

Identifier Type: -

Identifier Source: org_study_id

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