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

Postpartum Thyroiditis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03641638
• Other study ID #: CNNC416H
• Status: Recruiting
• Start date: August 31, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2018
• Source: China National Nuclear Corporation 416 Hospital
• Contact: Ren Bo, Master
• Phone: 8618602868203
• Email: 49520387[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postpartum Thyroiditis
• Thyroiditis

Locations

Country	Name	City	State
China	China National Nuclear corporation 416 Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
China National Nuclear Corporation 416 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the incidence rate of PPT in different TPOAb levels in early pregnancy.	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