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NCT00388297 · ClinicalTrials.gov registry record · Phase 3
Thyroid Therapy for Mild Thyroid Deficiency in Pregnancy
A Phase 3 study, sponsored by The George Washington University Biostatistics Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,203
- Enrollment target
NCT00388297: Completed Phase 3 study, sponsored by The George Washington University Biostatistics Center.
NCT00388297 is a Phase 3 study that has completed, run by The George Washington University Biostatistics Center. The registered enrollment target is 1,203 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00388297, a Phase 3 study, has completed, sponsored by The George Washington University Biostatistics Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,203 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether treating women, who are diagnosed with a mild imbalance of thyroid hormones during pregnancy, with thyroid hormone replacement affects their children's intellectual development at 5 years of age.
Primary Outcome
The primary outcome was death or IQ score at 5 years of age (or at 3 years of age if the 5-year examination was missing). The full-scale IQ was assessed with the use of the Wechsler Preschool and Primary Scale of Intelligence III (WPPSI-III) at 5 years of age or the overall (general conceptual ability) score from the Differential Ability Scales-II at 3 years of age if the WPPSI-III score was not available. Results are expressed as an age-standardized score, with an expected population mean of 10
Interventions
- DRUG Levothyroxine
- DRUG Placebo for Levothyroxine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,203 participants |
| Start Date | 2006-10 |
| Est. Completion | 2015-10 |
| Phase | Phase 3 |
What the finished NCT00388297 record still lists
NCT00388297 is an interventional study that assigns participants to a tested intervention. Its 1,203 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% higher).
The record links to 0 conditions, and to 2 interventions - of which Levothyroxine is the first listed.
NCT00388297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00388297 about?
NCT00388297 is a clinical study titled "Thyroid Therapy for Mild Thyroid Deficiency in Pregnancy". The purpose of this study is to determine whether treating women, who are diagnosed with a mild imbalance of thyroid hormones during pregnancy, with thyroid hormone replacement affects their children's intellectual development at 5 years of age.
What is the current status of trial NCT00388297?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,203 participants. The study started on 2006-10. Estimated completion is 2015-10.
What interventions are being tested in trial NCT00388297?
The interventions under investigation include: Levothyroxine (DRUG), Placebo for Levothyroxine (DRUG).
Who is sponsoring clinical trial NCT00388297?
This trial is sponsored by The George Washington University Biostatistics Center, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00388297's enrollment target sits among peer trials
1,203 220th of 2000 higher than 1,781 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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