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Thyroid Therapy for Mild Thyroid Deficiency in Pregnancy (TSH)
This study has been completed.
Sponsor:
The George Washington University Biostatistics Center
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier:
NCT00388297
First received: October 12, 2006
Last updated: September 9, 2016
Last verified: September 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Subclinical Hypothyroidism Hypothyroxinemia Pregnancy | Drug: Levothyroxine Drug: Placebo for Levothyroxine | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized Trial of Thyroxine Therapy for Subclinical Hypothyroidism or Hypothyroxinemia Diagnosed During Pregnancy |
Resource links provided by NLM:
Further study details as provided by The George Washington University Biostatistics Center:
Primary Outcome Measures:
- Intellectual function of children at 5 years of age, as measured by the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III), in women diagnosed with a) subclinical hypothyroidism or b) hypothyroxinemia during the first half of pregnancy [ Time Frame: 60 months of age ]
Secondary Outcome Measures:
- Cognitive, Motor and Language Scale Scores from the Bayley Certified Scales of Infant Development III Edition [ Time Frame: 12 and 24 months of age ]
- Cognitive and achievement levels from two DAS-II subtests (Recall of Digits Forward and Recognition of Pictures) [ Time Frame: 48 months of age ]
- Behavioral problems and social competencies at 36 and 60 months of age, as measured by the Child Behavior Checklist (CBCL) [ Time Frame: 36 and 60 months of age ]
- Fetal growth [ Time Frame: Delivery ]
- Preterm delivery [ Time Frame: Delivery ]
- Preeclampsia [ Time Frame: Duration of pregnancy, Delivery ]
- Abruption [ Time Frame: Duration of pregnancy, delivery ]
- Stillbirth [ Time Frame: Delivery ]
- Development of postpartum thyroid dysfunction [ Time Frame: 12 and 60 months postpartum ]
- Cognitive and achievement levels from the Differential Ability Scales (DAS II) [ Time Frame: 36 months ]
- Selected cognitive abilities from the subscales of the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III) [ Time Frame: 60 months ]
- Attention Deficit Hyperactivity Disorder (ADHD) index score from the Connors' Rating Scales (Parent-S) - Revised [ Time Frame: 48 months of age ]
| Enrollment: | 1203 |
| Study Start Date: | October 2006 |
| Study Completion Date: | October 2015 |
| Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Levothyroxine
Levothyroxine
|
Drug: Levothyroxine
Coded study drug is thyroxine encapsulated in a gel capsule; matching placebo contains only cellulose. Color of capsule corresponds to mcg dose level (100mcg or 25 mcg). Subjects in subclinical hypothyroidism stratum are started on 1 capsule of 100 mcg per day; subjects in hypothyroxinemia stratum are started on 2 capsules of 25 mcg per day. Thyroxine dosing adjustments for both strata are determined centrally, using an algorithm, based on results of monthly TSH or free-T4 assays. Subjects take study medication until delivery.
|
|
Placebo Comparator: Placebo for Levothyroxine
Placebo for Levothyroxine
|
Drug: Placebo for Levothyroxine |
Detailed Description:
Published research reports have stimulated national and international controversy regarding the value of maternal thyroxine therapy given to improve neurodevelopment of the fetus in women with variously defined hypothyroidism. These reports have led to conflicting and confusing recommendations as to whether or not all pregnant women in the U.S. should be screened for subclinical hypothyroidism or hypothyroxinemia.
Pregnant women less than 20 weeks gestation will have a blood test to screen for subclinical hypothyroidism or hypothyroxinemia. If eligible for the trial, patients will receive levothyroxine or placebo until delivery. Blood draws will be done at monthly study visits and the dosage will be adjusted based on test results. The children of these patients will have developmental testing done annually until they are 5 years of age.
Comparison(s): thyroxine supplementation versus placebo given during pregnancy to determine whether therapy is effective in improving intellectual ability at 5 years of age.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Subclinical Hypothyroidism as defined by an elevated TSH (≥ 3.00 mU/L) and a free-T4 in the normal range (i.e. 0.86 to 1.90 ng/dL) or Hypothyroxinemia as defined by a TSH in the normal range (0.08 to 2.99 micrometers (mU)/L) and a low free-T4 (<0.86 ng/dL)
- Singleton Pregnancy
- Gestational age at randomization between 8 weeks 0 days and 20 weeks 6 days
Exclusion Criteria:
- Major fetal anomaly or demise
- Planned termination of the pregnancy
- History of thyroid cancer or current thyroid disease requiring medication
- Diabetes, on medication (insulin, glyburide)
- Collagen vascular disease (autoimmune disease), such as lupus, scleroderma and polymyalgia rheumatica, on medication
- Receiving anticoagulant therapy
- Depression, currently on treatment with tricyclics or selective serotonin reuptake inhibitors (SSRIs)
-
Other known serious maternal medical complications including:
- Chronic hypertension requiring antihypertensive medication (including diuretics)
- Epilepsy or other seizure disorder, on medication
- Active or chronic liver disease (acute hepatitis, chronic active hepatitis) with persistently abnormal liver enzymes
- Cancer (including melanoma but excluding other skin cancers)
- Heart disease (tachyrhythmia, class II or greater heart disease or on heart medication). Mitral valve prolapse without arrhythmia is not an exclusion.
- Asthma, on oral corticosteroids
- Known illicit drug or alcohol abuse during current pregnancy
- Delivery at a non-network hospital
- Participation in another intervention study that influences maternal and fetal morbidity and mortality, or participation in this trial in a previous pregnancy
- Unwilling or unable to commit to 5 year follow-up of the infant
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388297
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388297
Locations
| United States, Alabama | |
| University of Alabama - Birmingham | |
| Birmingham, Alabama, United States, 35249 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, New York | |
| Columbia University | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Ohio | |
| Case Western University | |
| Cleveland, Ohio, United States, 44109 | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oregon | |
| Oregon Health & Sciences University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| University of Pittsburgh Magee Womens Hospital | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Rhode Island | |
| Brown University | |
| Providence, Rhode Island, United States, 02905 | |
| United States, Texas | |
| University of Texas - Southwest | |
| Dallas, Texas, United States, 75235 | |
| University of Texas Medical Branch - Galveston | |
| Galveston, Texas, United States, 77555 | |
| University of Texas-Houston | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| University of Utah Medical Center | |
| Salt Lake City, Utah, United States, 84132 | |
Sponsors and Collaborators
The George Washington University Biostatistics Center
National Institute of Neurological Disorders and Stroke (NINDS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
| Principal Investigator: | Brian Casey, MD | University of Texas Southwestern Medical Center |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Keywords provided by The George Washington University Biostatistics Center:
|
Subclinical Hypothyroidism Hypothyroxinemia Thyroid Pregnancy Intellectual Development |
Additional relevant MeSH terms:
|
Hypothyroidism Thyroid Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on July 17, 2017