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NCT03115515 · ClinicalTrials.gov registry record · NA
Safety and Efficacy of Empiric Levothyroxine (LT4) Dose Increase Versus Individualized LT4 Dose Increase in Hypothyroid Women During Pregnancy
A NA study, sponsored by Medstar Health Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT03115515: Completed NA study, sponsored by Medstar Health Research Institute.
NCT03115515 is a NA study that has completed, run by Medstar Health Research Institute. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03115515, a NA study, has completed, sponsored by Medstar Health Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
In women who require thyroid hormone replacement medication, the investigators will compare 2 ways to adjust thyroid medication during pregnancy to determine superiority in maintaining optimal blood levels of thyroid hormone. Thyroid hormone requirements increase significantly in pregnancy and it is important that blood levels of thyroid hormone remain normal so the fetus, which cannot make its own thyroid hormone has enough for early prenatal development. This trial compares 2 methods for adjusting thyroid medicine during pregnancy in women with known thyroid disease. Pregnant women (age 18 to 45) who take thyroid medication will be randomized to either 1) a 2-dose per week increase in thyroid medicine once pregnancy is confirmed, followed by dose adjustments every 2-4 weeks, or 2) adjustments in thyroid medication every 2-4 weeks in micrograms per day based on results of blood tests. The investigators will compare thyroid hormone levels throughout pregnancy between the groups of mothers to determine which method is superior in meeting the increased thyroid hormone requirements during pregnancy.
Primary Outcome
% of TSH values within trimester-specific goal range according to study group
Interventions
- DRUG levothyroxine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-08 |
| Est. Completion | 2018-02 |
| Phase | NA |
What the finished NCT03115515 record still lists
NCT03115515 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which levothyroxine is the first listed.
NCT03115515 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03115515 about?
NCT03115515 is a clinical study titled "Safety and Efficacy of Empiric Levothyroxine (LT4) Dose Increase Versus Individualized LT4 Dose Increase in Hypothyroid Women During Pregnancy". In women who require thyroid hormone replacement medication, the investigators will compare 2 ways to adjust thyroid medication during pregnancy to determine superiority in maintaining optimal blood levels of thyroid hormone. Thyroid hormone requirements increase significantly in pregnancy and it is...
What is the current status of trial NCT03115515?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2011-08. Estimated completion is 2018-02.
What interventions are being tested in trial NCT03115515?
The interventions under investigation include: levothyroxine (DRUG).
Who is sponsoring clinical trial NCT03115515?
This trial is sponsored by Medstar Health Research Institute, which has 115 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03115515's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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