The Effect of Thyroid Antibodies on Female Reproductive Function and Pregnancy Outcomes
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04952012
Collaborator
First People's Hospital of Yuhang (Other), Taizhou Women and Children's Hospital Affiliated to Wenzhou Medical University (Other), Changxing People's Hospital (Other)
4,000
1
24
166.8
Study Details
Study Description
Brief Summary
Some women at reproductive age have positive antithyroid antibodies (ATAs). Thyroid peroxidase antibody (TPOAb) and thyroglobulin antibody (TgAb) are the most common ATAs. This study aimed to evaluate the impact of ATAs on maturation of women reproductive system and pregnancy outcomes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
4000 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
The Effect of Thyroid Antibodies on Female Reproductive Function and Pregnancy Outcomes
Actual Study Start Date
:
Nov 30, 2020
Anticipated Primary Completion Date
:
Nov 30, 2021
Anticipated Study Completion Date
:
Nov 30, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ATA-positive
|
Drug: LT4
LT4 is used to improve the thyroid function of pregnant women.
|
| ATA-negative
|
Drug: LT4
LT4 is used to improve the thyroid function of pregnant women.
|
Outcome Measures
Primary Outcome Measures
- Incidence rate of pregnancy complications in women with or without thyroid antibodies [1 year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Age during 18-45y;
-
Women tested for TPOAb and/or TgAb, TSH, free T3, free T4, total T3 and total T4 during the 1st trimester of pregnancy
Exclusion Criteria:
-
Multiple pregnancies;
-
Age < 18 y or > 40 y;
-
L-T4 or PTU intervention before pregnancy;
-
Other autoimmune diseases.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | China | 310009 |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- First People's Hospital of Yuhang
- Taizhou Women and Children's Hospital Affiliated to Wenzhou Medical University
- Changxing People's Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04952012
Other Study ID Numbers:
- 2020-678
First Posted:
Jul 7, 2021
Last Update Posted:
Jul 7, 2021
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms: