Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that has completed, run by Medstar Health Research Institute. The registered enrollment target is 60 participants.
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.
Interventions
- DRUG levothyroxine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-08 |
| Est. Completion | 2018-02 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03115515
The ClinicalTrials.gov registry entry for NCT03115515 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medstar Health Research Institute, which has 115 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which levothyroxine is the first listed.
NCT03115515 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.