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

• Conditions: Diseases Pregnancy Thyroid

• Registration Number: NCT02966405
• Lead Sponsor: Xiaomei Zhang

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.

Study Timeline

• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-11-14
• Study First Posted: 2016-11-17
• Study Start: 2016-12
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-13
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection the FT3,FT4,TSH,TPOAb of the pregnant women in trimester of pregnancy.	up to 2 years	Detection the FT3,FT4,TSH,TPOAb of the pregnant women in trimester of pregnancy.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University International Hospital; 🇨🇳 Changping, Beijing, China