Correlation Between Different Levels of Thyroid Peroxidase Antibody and Postpartum Thyroiditis in Early Pregnancy

August 21, 2018 updated by: BO Ren, China National Nuclear Corporation 416 Hospital

Correlation Between Different Levels of Thyroid Peroxidase Antibody and Postpartum Thyroiditis in Early Pregancy

At present, attention to thyroid disease during pregnancy is increasing at home and abroad, but there is relatively little concern about postpartum thyroid disease, especially high incidence of postpartum thyroiditis (PPT). This observational study is to investigate the relationship between different levels of thyroid peroxidase antibody (TPOAb) and postpartum thyroiditis (PPT) in early pregnancy (1-12 weeks of pregnancy), and to explore whether PPT can be predicted by different TPOAb levels. According to the TPOAb level in early pregnancy, the postpartum of pregnant women was followed up, PPT was detected early, and intervention was performed according to thyroid dysfunction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

First pregnant women who between the ages of 18 to 35 years old and normal thyroid function before pregnancy were selected. Recruit 300 pregnant women who early pregnancy (1-12 weeks of pregnancy) screening TPOAb positive and normal Free triiodothyronine (FT3), normal free thyroxine (FT4) ,Thyroid Stimulating Hormone (TSH) <4.78mIU / L as the observation group. They will be divided into low-level group (TPOAb at 34-102 IU/ml), medium-level group (TPOAb at 103-204 IU/ml), and high-level group (TPOAb>205) according to TPOAb. Recruit 100 pregnant women who early pregnancy (1-12 weeks of pregnancy) screening TPOAb negative and normal FT3, normal FT4,TSH <4.78mIU / L as the Control group.

Thyroid function (FT3, FT4, TSH) and TPOAb, thyroglobulin antibody(TgAb) ,thyroid hormone receptor antibody(TRAb) will be screened in the observation group and the control group at 3 months, 6 months, and 12 months after delivery. If the mother is diagnosed with postpartum thyroiditis (PPT), continue to screen for thyroid function (FT3, FT4, TSH) and thyroid antibodies (TPOAb, TRAb, TgAb) 18 months after delivery. The correlation between the early pregnancy TPOAb level and postpartum thyroiditis was analyzed between the observation group and the control group and the observation group. It was explored whether the occurrence of postpartum thyroiditis (PPT) can be predicted according to the TPOAb level in the first trimester. And targeted maternal effective follow-up and timely intervention to treat PPT provide important basis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Tang shi, Master
  • Phone Number: +860288221514
  • Email: 49520387@qq.com

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • China National Nuclear corporation 416 Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

300 pre-pregnancy tests for thyroid function (FT3, FT4, TSH) were normal, initial pregnancy under 30 years old, early screening (1-12 weeks of pregnancy), initial screening of TPOAb positive, thyroid function: normal FT3, FT4, TSH <4.78 mIU/L Females were observed and divided into low-level groups (TPOAb at 34-102 IU/ml), medium-level groups (TPOAb at 103-204 IU/ml), and high-level groups (TPOAb > 205 IU/ml) according to TPOAb.

100 cases. 100 pre-pregnancy tests for thyroid function (FT3, FT4, TSH) and normal antibodies, first pregnancy under 30 years old, early pregnancy (1-12 weeks of pregnancy), initial screening for thyroid-related antibody negative and thyroid function: FT3, FT4 normal, TSH<4.78 Healthy women with mIU/L were the control group.

Description

Inclusion Criteria:

  1. Observation group:

    • Pre-pregnancy tests for normal thyroid function (FT3, FT4, TSH)
    • First pregnancy between the ages of 18 to 35 years old
    • Early screening (1-12 weeks of pregnancy) initial screening TPOAb positive，thyroid function FT3, FT4 normal, TSH<4.78mIU/ L

  2. Control group:

    • Pre-pregnancy tests for normal thyroid function (FT3, FT4, TSH) and antibodies
    • First pregnancy between the ages of 18 to 35 years old
    • Early pregnancy (1-12 weeks of pregnancy) initial screening negative thyroid-related antibody and thyroid function FT3, FT4 normal, TSH< 4.78 mIU/L.

Exclusion Criteria:

  • Combined with other autoimmune diseases (such as systemic lupus erythematosus, etc.)
  • Type 1 diabetes
  • Gestational diabetes;
  • Primary screening TRAb positive;
  • Previous patients with Graves, subacute thyroiditis,chronic hepatitis
  • Artificial pregnancy
  • Suffering from liver and kidney dysfunction and other major diseases
  • Have a history of adverse pregnancy
  • Pregnant women with premature birth, miscarriage, intrauterine dysplasia and other unhealthy pregnancies withdrew from observation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Low level of TPOAb
normal thyroid function (FT3, FT4, TSH) before pregnancy, First pregnancy under 35 years old, early screening (1-12 weeks of pregnancy), initial screening of TPOAb positive, thyroid function: normal FT3 and FT4, TSH<4.78mIU/L，TPOAb at 34-102 IU/ml.
Medium level of TPOAb
normal thyroid function (FT3, FT4, TSH) before pregnancy, First pregnancy under 35 years old, early screening (1-12 weeks of pregnancy), initial screening of TPOAb positive, thyroid function: normal FT3 and FT4, TSH<4.78mIU/L，TPOAb at 103-204 IU/ml.
High level of TPOAb
normal thyroid function (FT3, FT4, TSH) before pregnancy, First pregnancy under 35 years old, early screening (1-12 weeks of pregnancy), initial screening of TPOAb positive, thyroid function: normal FT3 and FT4, TSH<4.78mIU/L，TPOAb >205IU/ml.
Control group
normal thyroid function (FT3, FT4, TSH) before pregnancy, First pregnancy under 35 years old, early screening (1-12 weeks of pregnancy), initial screening of negative Thyroid antibody, thyroid function: normal FT3 and FT4, TSH<4.78mIU/L.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measure the incidence rate of PPT in different TPOAb levels in early pregnancy.
Time Frame: 22 months
The levels of TPOAb include:Low level of TPOAb(34-102 IU/ml),Medium level of TPOAb(103-204 IU/ml),High level of TPOAb(>205IU/m), TPOAb negative.
22 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Nuclear Corporation 416 Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ren Bo, Master, China National Nuclear corporation 416 Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CNNC416H

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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