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A Randomized Trial of Thyroxine Therapy for Subclinical Hypothyroidism or Hypothyroxinemia Diagnosed During Pregnancy
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.
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.
Age
All ages
Sex
FEMALE
Healthy Volunteers
Yes
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
Start Date
October 1, 2006
Primary Completion Date
August 1, 2015
Completion Date
October 1, 2015
Last Updated
February 21, 2019
1,203
ACTUAL participants
Levothyroxine
DRUG
Placebo for Levothyroxine
DRUG
Lead Sponsor
The George Washington University Biostatistics Center
Collaborators
NCT06768060
NCT07462065
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06273683