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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02966405
Enrollment
1000
Registered
2016-11-17
Start date
2016-12-31
Completion date
2020-12-31
Last updated
2020-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diseases Pregnancy Thyroid

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.

Interventions

None listed

Sponsors

Xiaomei Zhang
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Detection the FT3,FT4,TSH,TPOAb of the pregnant women in trimester of pregnancy.up to 2 yearsDetection the FT3,FT4,TSH,TPOAb of the pregnant women in trimester of pregnancy.

Secondary

MeasureTime frameDescription
The influence of thyroid disorders on pregnancy.up to 2 yearsPregnant women:subclinical hypothyroidism,hypertension of pregnancy, eclampsia gravidarum, gestational diabetes mellitus, abortion, stillbirth.
The influence of thyroid disorders its outcomes.up to 2 yearsNewborn:neonatal death,neonatal respiratory distress syndrome, low birth weight, macrosomia,et al.

Countries

China

Contacts

Primary ContactXiao M zhang, Chief
yuanning00076@126.com010 69006260

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026