Thyroid Therapy for Mild Thyroid Deficiency in Pregnancy

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The George Washington University Biostatistics Center
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Neurological Disorders and Stroke (NINDS)

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:

1. Major fetal anomaly or demise

2. Planned termination of the pregnancy

3. History of thyroid cancer or current thyroid disease requiring medication

4. Diabetes, on medication (insulin, glyburide)

5. Collagen vascular disease (autoimmune disease), such as lupus, scleroderma and polymyalgia rheumatica, on medication

6. Receiving anticoagulant therapy

7. Depression, currently on treatment with tricyclics or selective serotonin reuptake inhibitors (SSRIs)

8. Other known serious maternal medical complications including:

1. Chronic hypertension requiring antihypertensive medication (including diuretics)

2. Epilepsy or other seizure disorder, on medication

3. Active or chronic liver disease (acute hepatitis, chronic active hepatitis) with persistently abnormal liver enzymes

4. Cancer (including melanoma but excluding other skin cancers)

5. Heart disease (tachyrhythmia, class II or greater heart disease or on heart medication). Mitral valve prolapse without arrhythmia is not an exclusion.

6. Asthma, on oral corticosteroids

9. Known illicit drug or alcohol abuse during current pregnancy

10. Delivery at a non-network hospital

11. Participation in another intervention study that influences maternal and fetal morbidity and mortality, or participation in this trial in a previous pregnancy

12. Unwilling or unable to commit to 5 year follow-up of the infant