Postpartum ThyroiditisNCT03641638
Correlation Between Different Levels of Thyroid Peroxidase Antibody and Postpartum Thyroiditis in Early Pregnancy
An observational study of Postpartum Thyroiditis, run by China National Nuclear Corporation 416 Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Thyroiditis
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China National Nuclear corporation 416 Hospital
Chengdu, Sichuan, 610000
Ren BO, Master, 8618602868203, 49520387@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Postpartum Thyroiditis
- Keywords
- Postpartum thyroiditis, PPT, TPOAb
- Medical subject headings
- Postpartum Thyroiditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start31 Aug 2018 (estimated)
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum ThyroiditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Nuclear Corporation 416 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BO Ren, China National Nuclear Corporation 416 Hospital
- Investigators
- Ren Bo, Master, Principal investigator, China National Nuclear Corporation 416 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641638
- Sponsor's protocol ID
- CNNC416H
- Status last verified
- Aug 2018
- First submitted
- 8 Jul 2018
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Different Levels of Thyroid Peroxidase Antibody and Postpartum Thyroiditis in Early Pregancy
- ClinicalTrials.gov ID
- NCT03641638
- Acronym / sponsor ID
- CNNC416H
- Conditions
- Postpartum Thyroiditis
- Keywords
- Postpartum thyroiditis, PPT, TPOAb
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- China National Nuclear Corporation 416 HospitalUniversity, hospital or other
- Study start
- 31 Aug 2018 (estimated)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (8 listed)
- Observation group:
- Control group:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ren Bo, Master principal investigator
China National Nuclear Corporation 416 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Thyroiditis, run by China National Nuclear Corporation 416 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ren Bo, Master (8618602868203, 49520387@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the incidence rate of PPT in different TPOAb levels in early pregnancy. (time frame: 22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018; AzTrials last refreshed its copy on 1 Nov 2026.