Trial · NCT00388297
Thyroid Therapy for Mild Thyroid Deficiency in Pregnancy
NCT00388297, Phase 3, Completed, The George Washington University Biostatistics Center; results first posted 2019-01-30
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ConductScience Library. Thyroid Therapy for Mild Thyroid Deficiency in Pregnancy. Trials, record NCT00388297. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00388297
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Thyroid Therapy for Mild Thyroid Deficiency in Pregnancy
- NCT number
- NCT00388297
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,203 participants, actual
- Lead sponsor
- The George Washington University Biostatistics Center
- Conditions
- Subclinical Hypothyroidism, Hypothyroxinemia, Pregnancy
- Interventions
- Levothyroxine, Placebo for Levothyroxine
- First posted
- 2006-10-16
- Last updated
- 2019-02-21
- Results first posted
- 2019-01-30
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intellectual Function of Children at 5 Years of Age in Women Diagnosed With a) Subclinical Hypothyroidism or b) Hypothyroxinemia During the First Half of Pregnancy, or Death. | 60 months of age | 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 100 and a standard deviation of 15. Death before 3 years of age was assigned a score of 0 (lowest possible rank) and was included in the estimation of the median. For Quotient and Composite score: below 70 is Extremely Low, 70-79 is Borderline, 80-89 is Low Average, 90-109 is Average, 110-119 is High Average, 120-129 is Superior, 130+ |
| Secondary | Week of Gestation at Delivery | Delivery | Gestational age at delivery and preterm birth \< 37 weeks' gestation or \< 34 weeks' gestation |
| Secondary | Number of Participants With Preterm Delivery | Delivery | Preterm delivery at less than 37 weeks or less than 34 weeks gestation |
| Secondary | Selected Cognitive Abilities From the Subscales of the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III) | 60 months | Standardized full-scale IQ scores from the Wechsler Preschool and Primary Scale of Intelligence III (WPPSI-III) at 5 years of age. Quotient and Composite scores have a mean of 100 and a standard deviation of 15. Subtest scaled scores have a mean of 10 and a standard deviation of 3. For Quotient and Composite score: below 70 is Extremely Low, 70-79 is Borderline, 80-89 is Low Average, 90-109 is Average, 110-119 is High Average, 120-129 is Superior, 130+ is Very Superior. |
| Secondary | Cognitive and Achievement Levels From the Differential Ability Scales (DAS II) | 36 months | Overall general conceptual ability score as measured by the DAS-II at 36 months of age. GCA General Conceptual Ability Classification ≥ 130 Very high 120-129 High 110-119 Above average 90-109 Average 80-89 Below average 70-79 Low ≤ 69 Very low |
| Secondary | Cognitive and Achievement Levels From Two DAS-II Subtests (Recall of Digits Forward and Recognition of Pictures) | 48 months of age | Cognitive and achievement levels from two DAS-II subtests (Recall of Digits Forward and Recognition of Pictures) GCA General Conceptual Ability Classification ≥ 130 Very high 120-129 High 110-119 Above average 90-109 Average 80-89 Below average 70-79 Low ≤ 69 Very low |
| Secondary | Cognitive, Motor and Language Scale Scores From the Bayley Certified Scales of Infant Development III Edition | 12 and 24 months of age | Composite scores are derived for cognitive, language, and motor development and scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160. Results can also be expressed as percentile ranks relative to the standardization sample, with a mean and median of 50 and range from 1 to 99 |
| Secondary | Behavioral Problems and Social Competencies at 36 and 60 Months of Age, as Measured by the Child Behavior Checklist (CBCL) | 36 and 60 months of age | Behavioral problems and social competencies at 36 and 60 months of age, as measured by the Child Behavior Checklist (CBCL). The CBCL is filled out by the caregiver. Each of the 100 questions indicates a behavior for which the caregiver scores as Not True (0), Sometimes True (1), or Often True (2). The scores for all the questions are then summed and evaluated against the normative data/T-scores. A Tscore of less than 60 is considered to be in the normal range. A T score of 60-63 is a borderline, and a T score of more than 63 is in the clinical range. Lower scores represent better outcomes. |
| Secondary | Attention Deficit Hyperactivity Disorder (ADHD) Index Score From the Connors' Rating Scales (Parent-S) - Revised | 48 months of age | The Conners' Rating Scales-Revised were used to assess attention deficit-hyperactivity disorder (ADHD). A T score of 45 to 55 is considered to be typical or average; a T score of 44 or less is not a concern, a T score of 56 to 60 is considered to be a borderline score, and a T score of 61 or higher indicates a possible or clinically significant problem. |
| Secondary | Participants With Placental Abruption | Duration of pregnancy, delivery | Clinically significant placental abruption will be determined by centralized (blinded) chart review |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intellectual Function of Children at 5 Years of Age in Women Diagnosed With a) Subclinical Hypothyroidism or b) Hypothyroxinemia During the First Half of Pregnancy, or Death. | 60 months of age | score on a scale | MEDIAN | |
| SECONDARY | Week of Gestation at Delivery | Delivery | weeks | MEAN | |
| SECONDARY | Number of Participants With Preterm Delivery | Delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Selected Cognitive Abilities From the Subscales of the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III) | 60 months | score on a scale | MEDIAN | |
| SECONDARY | Cognitive and Achievement Levels From the Differential Ability Scales (DAS II) | 36 months | score on a scale | MEDIAN | |
| SECONDARY | Cognitive and Achievement Levels From Two DAS-II Subtests (Recall of Digits Forward and Recognition of Pictures) | 48 months of age | For all outcomes except the primary outcome, the potential follow-up cohort consisted of 335 children in the levothyroxine group and 329 in the placebo group for the mothers with subclinical hypothyroidism and for the hypothyroxinemia group - 260 children in the levothyroxine group and 255 children in the placebo group. | score on a scale | MEDIAN |
| SECONDARY | Cognitive, Motor and Language Scale Scores From the Bayley Certified Scales of Infant Development III Edition | 12 and 24 months of age | For all outcomes except the primary outcome the potential follow-up cohort in the subclinical hypothyroidism groups consisted of 335 children in the levothyroxine group and 329 in the placebo group, and for the hypothyroxinema groups: 254 children in the levothryoxine group and 253 children in the placebo group. | score on a scale | MEDIAN |
| SECONDARY | Behavioral Problems and Social Competencies at 36 and 60 Months of Age, as Measured by the Child Behavior Checklist (CBCL) | 36 and 60 months of age | The potential follow-up cohort consisted of 335 children in the levothyroxine group and 329 in the placebo group for subclinical hypothyroidism and for hypothyroxinemia - 260 children in the levothyroxine group and 255 in the placebo group. A Child Behavior Checklist T score of less than 60 is considered to be in the normal range. | T-score | MEDIAN |
| SECONDARY | Attention Deficit Hyperactivity Disorder (ADHD) Index Score From the Connors' Rating Scales (Parent-S) - Revised | 48 months of age | T-score | MEDIAN | |
| SECONDARY | Participants With Placental Abruption | Duration of pregnancy, delivery | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group140
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intellectual Function of Children at 5 Years of Age in Women Diagnosed With a) Subclinical Hypothyroidism or b) Hypothyroxinemia During the First Half of Pregnancy, or Death. | Levothyroxine for Subclinical Hypothyroidism | 97 | 95% Confidence Interval 94 to 99 | score on a scale | |
| Intellectual Function of Children at 5 Years of Age in Women Diagnosed With a) Subclinical Hypothyroidism or b) Hypothyroxinemia During the First Half of Pregnancy, or Death. | Placebo for Levothyroxine - Subclinical Hypothyroidism | 94 | 95% Confidence Interval 92 to 96 | score on a scale | |
| Intellectual Function of Children at 5 Years of Age in Women Diagnosed With a) Subclinical Hypothyroidism or b) Hypothyroxinemia During the First Half of Pregnancy, or Death. | Levothyroxine for Hypothyroxinemia | 94 | 95% Confidence Interval 91 to 95 | score on a scale | |
| Intellectual Function of Children at 5 Years of Age in Women Diagnosed With a) Subclinical Hypothyroidism or b) Hypothyroxinemia During the First Half of Pregnancy, or Death. | Placebo for Levothyroxine - Hypothyroxinemia | 91 | 95% Confidence Interval 89 to 93 | score on a scale | |
| Week of Gestation at Delivery | Levothyroxine for Subclinical Hypothyroidism | 39.1 | Standard Deviation 2.5 | weeks | |
| Week of Gestation at Delivery | Placebo for Levothyroxine - Subclinical Hypothyroidism | 38.9 | Standard Deviation 3.1 | weeks | |
| Week of Gestation at Delivery | Levothyroxine for Hypothyroxinemia | 39.0 | Standard Deviation 2.4 | weeks | |
| Week of Gestation at Delivery | Placebo for Levothyroxine - Hypothyroxinemia | 38.8 | Standard Deviation 3.1 | weeks | |
| Number of Participants With Preterm Delivery | Levothyroxine for Subclinical Hypothyroidism | Preterm birth < 34 wk | 9 | Participants | |
| Number of Participants With Preterm Delivery | Placebo for Levothyroxine - Subclinical Hypothyroidism | Preterm birth < 34 wk | 10 | Participants |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Levothyroxine for Subclinical Hypothyroidism | 339 | |
| Overall Study | STARTED | Placebo for Levothyroxine - Subclinical Hypothyroidism | 338 | |
| Overall Study | STARTED | Levothyroxine for Hypothyroxinemia | 265 | |
| Overall Study | STARTED | Placebo for Levothyroxine for Hypothyroxinemia | 261 | |
| Overall Study | COMPLETED | Levothyroxine for Subclinical Hypothyroidism | 323 | |
| Overall Study | COMPLETED | Placebo for Levothyroxine - Subclinical Hypothyroidism | 326 | |
| Overall Study | COMPLETED | Levothyroxine for Hypothyroxinemia | 254 | |
| Overall Study | COMPLETED | Placebo for Levothyroxine for Hypothyroxinemia | 253 | |
| Overall Study | NOT COMPLETED | Levothyroxine for Subclinical Hypothyroidism | 16 | |
| Overall Study | NOT COMPLETED | Placebo for Levothyroxine - Subclinical Hypothyroidism | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vomiting/Nausea | Gastrointestinal disorders | Levothyroxine for Subclinical Hypothyroidism | 18 | 338 | |
| other | Vomiting/Nausea | Gastrointestinal disorders | Placebo for Levothyroxine - Subclinincal Hypothyroidism | 8 | 336 | |
| other | Vomiting/Nausea | Gastrointestinal disorders | Levothyroxine for Hypothyroxinemia - Hypothyroxinemia | 10 | 261 | |
| other | Vomiting/Nausea | Gastrointestinal disorders | Placebo for Levothyroxine | 15 | 259 | |
| other | shortness of breath | Respiratory, thoracic and mediastinal disorders | Levothyroxine for Subclinical Hypothyroidism | 3 | 338 | |
| other | shortness of breath | Respiratory, thoracic and mediastinal disorders | Placebo for Levothyroxine - Subclinincal Hypothyroidism | 5 | 336 | |
| other | shortness of breath | Respiratory, thoracic and mediastinal disorders | Levothyroxine for Hypothyroxinemia - Hypothyroxinemia | 2 | 261 | |
| other | shortness of breath | Respiratory, thoracic and mediastinal disorders | Placebo for Levothyroxine | 2 | 259 | |
| other | Nervousness | General disorders | Levothyroxine for Subclinical Hypothyroidism | 4 | 338 | |
| other | Nervousness | General disorders | Placebo for Levothyroxine - Subclinincal Hypothyroidism | 3 | 336 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levothyroxine for Subclinical Hypothyroidism | ||
| Total, all-cause mortality | Placebo for Levothyroxine - Subclinincal Hypothyroidism | ||
| Total, all-cause mortality | Levothyroxine for Hypothyroxinemia - Hypothyroxinemia | ||
| Total, all-cause mortality | Placebo for Levothyroxine | ||
| Total, other adverse events | Levothyroxine for Subclinical Hypothyroidism | 51 | 338 |
| Total, other adverse events | Placebo for Levothyroxine - Subclinincal Hypothyroidism | 41 | 336 |
| Total, other adverse events | Levothyroxine for Hypothyroxinemia - Hypothyroxinemia | 25 | 261 |
| Total, other adverse events | Placebo for Levothyroxine | 34 | 259 |
| Total, serious adverse events | Levothyroxine for Subclinical Hypothyroidism | 4 | 339 |
| Total, serious adverse events | Placebo for Levothyroxine - Subclinincal Hypothyroidism | 2 | 338 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants16
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10HD036801 | Data Coord Ctr-NICHD Cooperative Multicenter Maternal Medicine Units Research Net | CLIFTON, REBECCA GERSNOVIEZ | GEORGE WASHINGTON UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2009 to 2021 | NIH RePORTER |
| U10HD021410 | Multicenter Network of Maternal Fetal Medicine Units | CARITIS, STEVE N | MAGEE-WOMEN'S RES INST AND FOUNDATION | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD027869 | NICHD Materal Fetal Medicine Units Network | TITA, ALAN THEVENET N. | UNIVERSITY OF ALABAMA AT BIRMINGHAM | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD027915 | NICHD Maternal Fetal Medicine Units Network | IAMS, JAY | OHIO STATE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1992 to 2015 | NIH RePORTER |
| U10HD027917 | Co-Operative Multicenter Trials in Obstetrics & Maternal Fetal Medicine | GONIK, BERNARD | WAYNE STATE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD034116 | Eunice Kennedy Shriver NICHD Maternal Fetal Medicine Units Network (U10) | CASEY, BRIAN M | UT SOUTHWESTERN MEDICAL CENTER | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1996 to 2015 | NIH RePORTER |
| U10HD034208 | Maternal Fetal Medicine Units Network | VARNER, MICHAEL W. | UNIVERSITY OF UTAH | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1996 to 2015 | NIH RePORTER |
| U10HD040485 | Maternal Fetal Medicine Network | WAPNER, RONALD | COLUMBIA UNIVERSITY HEALTH SCIENCES | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2001 to 2015 | NIH RePORTER |
| U10HD040500 | Brown/WIH Eunice Kennedy Shriver NICHD MFM Units Network Site | ROUSE, DWIGHT J | WOMEN AND INFANTS HOSPITAL-RHODE ISLAND | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2001 to 2015 | NIH RePORTER |
| U10HD040512 | NICHD Maternal Fetal Medicine Units Network | GROBMAN, WILLIAM ADAM | NORTHWESTERN UNIVERSITY AT CHICAGO | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2001 to 2015 | NIH RePORTER |
1 to 10 of 16
See all 16 grantsTrial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT00388297/registered?page=2