Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653907
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Levothyroxine Intervention in Pregnant Women with TSH 25 MIUL-upper Limit of Reference Range and Negative Thyroid Peroxidase Antibody
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Control Study of Levothyroxine Intervention in Pregnant Women with Thyroid Stimulating Hormone Between 25 MIUL and Upper Limit of Reference Range and Negative Thyroid Peroxidase Antibody
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIGHT
Brief Summary:
The goal of this clinical trial is to learn if levothyroxine L-T4 works to treat pregnant women with TSH 25 mIUL-the upper limit of reference range ULRR of pregnancy and TPOAb-negative It will also learn about the safety of L-T4 The main quesitons the investigator want to answer are
Will L-T4 reduce miscarriage rates and have an impact on pregnancy complications in pregnant participants
What medical issues do participants have when taking L-T4 during pregnancy -Investigators will compare L-T4 with placebo a substance with a similar appearance without medication to see if L-T4 could reduce miscarriage rates
Participants should
Take L-T4 or placebo during the whole pregnancy
Visit the hospital once every 6-8 weeks during pregnancy for checkups and tests
Keep a diary of their pregncny complications and daily record of L-T4 or placebo intake
Visit the hospital for examination 42 days postpartum for checkups and follow up by phone at 6 and 12 months postpartum
Will L-T4 reduce miscarriage rates and have an impact on pregnancy complications in pregnant participants
What medical issues do participants have when taking L-T4 during pregnancy -Investigators will compare L-T4 with placebo a substance with a similar appearance without medication to see if L-T4 could reduce miscarriage rates
Participants should
Take L-T4 or placebo during the whole pregnancy
Visit the hospital once every 6-8 weeks during pregnancy for checkups and tests
Keep a diary of their pregncny complications and daily record of L-T4 or placebo intake
Visit the hospital for examination 42 days postpartum for checkups and follow up by phone at 6 and 12 months postpartum
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None