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Clinical Trials/NCT02966405
NCT02966405
Unknown
Not Applicable

The Establish of Trimester-specific Reference Ranges for Thyroid Tests in Pregnant Women and the Influence of Thyroid Disorders on Pregnancy and Its Outcomes.

Xiaomei Zhang1 site in 1 country1,000 target enrollmentDecember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diseases Pregnancy Thyroid
Sponsor
Xiaomei Zhang
Enrollment
1000
Locations
1
Primary Endpoint
Detection the FT3,FT4,TSH,TPOAb of the pregnant women in trimester of pregnancy.
Last Updated
5 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
December 2020
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Xiaomei Zhang
Responsible Party
Sponsor Investigator
Principal Investigator

Xiaomei Zhang

Director

Peking University International Hospital

Eligibility Criteria

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.
  • 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • The influence of thyroid disorders its outcomes.(up to 2 years)
  • The influence of thyroid disorders on pregnancy.(up to 2 years)

Study Sites (1)

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