Thyroid Therapy for Mild Thyroid Deficiency in Pregnancy
Information source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Subclinical Hypothyroidism; Hypothyroxinemia; Pregnancy
Intervention: Levothyroxine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Official(s) and/or principal investigator(s):
Brian Casey, MD, Principal Investigator, Affiliation: University of Texas Southwestern Medical Center
Overall contact:
Catherine Y Spong, MD, Phone: 301-435-6894, Email: spongc@exchange.nih.gov
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.
Clinical Details
Official title: A Randomized Trial of Thyroxine Therapy for Subclinical Hypothyroidism or Hypothyroxinemia Diagnosed During Pregnancy
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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
Secondary outcome: Developmental delay at 12 and 24 months, using the Bayley Scales for Motor Development Index (MDI) and Psychomotor Development Index (PDI)Attention deficit at 48 months, using the Connors Rating Scales and the Developmental Neuropsychological Assessment (NEPSY) attention subtests Behavioral problems and social competencies at 36 and 60 months of age, as measured by the Child Behavior Checklist (CBCL) Fetal growth Preterm delivery Preeclampsia Abruption Stillbirth Development of postpartum thyroid dysfunction
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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 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 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
Locations and Contacts
Catherine Y Spong, MD, Phone: 301-435-6894, Email: spongc@exchange.nih.gov
University of Alabama - Birmingham, Birmingham, Alabama, United States; Recruiting
Allison Northen, RN, Phone: 205-934-1324, Email: anorthen@uab.edu
Dwight Rouse, MD, Principal Investigator
Northwestern University, Chicago, Illinois, United States; Recruiting
Gail Mallett, RN BSN, Phone: 312-926-2475, Email: g-mallett@northwestern.edu
Alan M Peaceman, MD, Principal Investigator
Wayne State University, Detroit, Michigan, United States; Recruiting
Nancy Hauff, MSN, Phone: 313-993-4430, Email: nhauff@med.wayne.edu
Yoram Sorokin, MD, Principal Investigator
Columbia University, New York, New York, United States; Recruiting
Sabine Bousleiman, Phone: 212-305-4348, Email: sb1080@columbia.edu
Ronald Wapner, MD, Principal Investigator
University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States; Recruiting
Karen Dorman, RN, Phone: 919-966-2550, Email: kdorman@med.unc.edu
John M Thorp, Jr., MD, Principal Investigator
Case Western University, Cleveland, Ohio, United States; Recruiting
Cynthia Milluzzi, BFA BSN, Phone: 216-778-8094, Email: cmilluzzi@metrohealth.org
Brian Mercer, MD, Principal Investigator
Ohio State University, Columbus, Ohio, United States; Recruiting
Francee Johnson, RN BSN, Phone: 614-293-5632, Email: johnson.126@osu.edu
Jay Iams, MD, Principal Investigator
Oregon Health & Sciences University, Portland, Oregon, United States; Not yet recruiting
Ellen Lairson, MN, Phone: 503-494-3131, Email: Lairsone@ohsu.edu
Jorge Tolosa, MD, Principal Investigator
University of Pittsburgh Magee Womens Hospital, Pittsburgh, Pennsylvania, United States; Recruiting
Peggy Cotroneo, RN, Phone: 412-641-4055, Email: mcotroneo@mail.magee.edu
Steve N Caritis, MD, Principal Investigator
Brown University, Providence, Rhode Island, United States; Recruiting
JoAnn Tillinghast, MSN, Phone: 401-274-1122, Ext: 1851, Email: jotillinghast@wihri.org
Donald Coustan, MD, Principal Investigator
University of Texas - Southwest, Dallas, Texas, United States; Recruiting
Lisa Moseley, RN, Phone: 214-590-8041, Email: lisa.moseley@utsouthwestern.edu
Kenneth J Leveno, MD, Principal Investigator
University of Texas-Houston, Houston, Texas, United States; Not yet recruiting
Krishna Cannon, RN, MBA, Phone: 713-500-6454, Email: Krishna.Cannon@uth.tmc.edu
Sean Blackwell, MD, Principal Investigator
University of Texas Medical Branch - Galveston, Galveston, Texas, United States; Recruiting
Joan Moss, Phone: 409-747-1733, Email: jemoss@utmb.edu
George Saade, MD, Principal Investigator
University of Utah Medical Center, Salt Lake City, Utah, United States; Recruiting
Peggy Ashby, RN, Phone: 801-585-5586, Email: Peggy.Ashby@hsc.utah.edu
Michael W Varner, MD, Principal Investigator
Additional Information
Click here for more information about this study
Starting date: October 2006
Ending date: February 2015
Last updated: May 27, 2008
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