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

Diseases Pregnancy Thyroid Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02966405
• Other study ID #: PekingUIH
• Status: Recruiting
• Start date: December 2016
• Est. completion date: December 2020

Study information

• Verified date: August 2020
• Source: Peking University International Hospital
• Contact: Xiao M zhang, Chief
• Phone: 010 69006260
• Email: yuanning00076[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diseases Pregnancy Thyroid
• Thyroid Diseases

Locations

Country	Name	City	State
China	Peking University International Hospital	Beijing	Beijing
China	Peking University International Hospital	Changping	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xiaomei Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 2 years
Secondary	The influence of thyroid disorders on pregnancy.	Pregnant women:subclinical hypothyroidism,hypertension of pregnancy, eclampsia gravidarum, gestational diabetes mellitus, abortion, stillbirth.	up to 2 years
Secondary	The influence of thyroid disorders its outcomes.	Newborn:neonatal death,neonatal respiratory distress syndrome, low birth weight, macrosomia,et al.	up to 2 years