CClinicalTrials.gg
Status unknownNCT02966405Updated Aug 13, 2020

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

An observational study in Diseases Pregnancy Thyroid, sponsored by Xiaomei Zhang. Status unknown at 2 sites in China. Open to female participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-13.

Sponsored by Xiaomei Zhang · Observational

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,000
Ages
19 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Diseases Pregnancy Thyroid

Browse trials for

03

In context

Thyroid Diseases

967 studies on the registry are indexed under Thyroid Diseases; 197 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 150 across 381 observational studies indexed under Thyroid Diseases.

Browse Thyroid Diseases studies →

Lead sponsor

Xiaomei Zhang is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • Healthy pregnant women

    A descriptive analysis involving 300 healthy pregnant women according NACB to the establish of trimester-specific reference ranges for thyroid tests in pregnant women.

  • Normal pregnant population

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 2 years

Secondary outcomes

  1. The influence of thyroid disorders on pregnancy.

    Pregnant women:subclinical hypothyroidism,hypertension of pregnancy, eclampsia gravidarum, gestational diabetes mellitus, abortion, stillbirth.

    Time frame: up to 2 years

  2. The influence of thyroid disorders its outcomes.

    Newborn:neonatal death,neonatal respiratory distress syndrome, low birth weight, macrosomia,et al.

    Time frame: up to 2 years

07

Study locations

2 of 2 sites recruiting
  • Peking University International Hospital
    Beijing, Beijing 102206, China
    Recruiting
  • Peking University International Hospital
    Changping, Beijing 102206, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 34570342 ↗
  • 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. PubMed 32847542 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02966405
Lead sponsor
Xiaomei Zhang
Responsible party
Xiaomei Zhang (Director, Peking University International Hospital) — Sponsor-investigator
First posted
Nov 17, 2016
Start date
Dec 2016
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Aug 13, 2020

Study contacts

Xiao M zhang, Chief
Contact
yuanning00076@126.com
010 69006260
Xiao M zhang, Chief
study chair · Peking University International Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion