Thyroid Therapy for Mild Thyroid Deficiency in Pregnancy

Completed · Phase 3 · Has a placebo group

Conditions studied: Subclinical Hypothyroidism, Hypothyroxinemia, Pregnancy

In brief

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.

Key facts

Study ID

NCT00388297

Run by

The George Washington University Biostatistics Center

People needed

1203

Starts

2006-10-01

Expected to finish

2015-10-01

Last updated by the study team

2019-02-21

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama - Birmingham — Birmingham, Alabama, United States
• Northwestern University — Chicago, Illinois, United States
• Wayne State University — Detroit, Michigan, United States
• Columbia University — New York, New York, United States
• University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
• Case Western University — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Oregon Health & Sciences University — Portland, Oregon, United States
• University of Pittsburgh Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
• Brown University — Providence, Rhode Island, United States
• University of Texas - Southwest — Dallas, Texas, United States
• University of Texas Medical Branch - Galveston — Galveston, Texas, United States
• University of Texas-Houston — Houston, Texas, United States
• University of Utah Medical Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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