Clinical trial NCT02966405: The Establish of Specific Reference Ranges for Thyroid Tests in Pregnant Women
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diseases Pregnancy Thyroid
Lead sponsor: Peking University International Hospital
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection the FT3,FT4,TSH,TPOAb of the pregnant women in trimester of pregnancy.
timeFrame: up to 2 years
Secondary outcomes:
measure: The influence of thyroid disorders on pregnancy.
timeFrame: up to 2 years
measure: The influence of thyroid disorders its outcomes.
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University International Hospital
state: Beijing
city: Changping
country: China
facility: Peking University International Hospital
state: Beijing
Study officials:
affiliation: Peking University International Hospital
name: Xiao M zhang, Chief
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.