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What Do You Need to Know About This Clinical Trial?

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Updated February 06, 2007

What Do You Need to Know About This Clinical Trial?
Question: What Do You Need to Know About This Clinical Trial?
A clinical trial, sponsored by the National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) is, as of late 2006, enrolling patients.

According to the researchers, the purpose of the study is to evaluate the effect of treatment of women who are pregnant and diagnosed with a mild hypothyroidism during the pregnancy, in terms of the intellectual development of the child at 5 years of age.

They are looking to find out if failing to treat a slightly underactive thyroid during pregnancy will affect the pregnancy, and ultimately, impair the child intellectually.

Answer: Plans are to inclue as many as 1,000 women in the study. More specifics on the study are outlined here .

How Can You Participate?

You may be eligible to participate if you meet these criteria:
  • Pregnant, between 8 to 20 weeks
  • A "single" pregnancy -- meaning no twins or multiples
  • Blood test results show* that your thyroid is mildly underactive
Note: You cannot have a history of thyroid cancer, and you cannot currently have thyroid disease for which you are receiving treatment. There are also additional criteria that will exclude you from the study, and they are outlined here.

What is Involved In the Study?

  • If you are enrolled, you'll receive either levothyroxine (a thyroid hormone replacement drug) or a placebo, until delivery.
  • During the pregnancy, you will be seen every 4 weeks for evaluation of the amount of medication taken, to receive medication for the next four weeks, for blood tests and any needed dosage adjustments, and assessment of any side effects.
  • After birth, your child will have developmental testing done annually each until the child is 5 years old.

Interested in Participating?

  • Find out if the trial is recruiting near you. Current and future trial locations include: University of Alabama - Birmingham; Northwestern University, Chicago, Illinois; Wayne State University, Detroit, Michigan; Columbia University, New York City; University of North Carolina - Chapel Hill; Case Western University, Cleveland, Ohio; Ohio State University, Columbus, Ohio; Oregon Health & Sciences University, Portland, Oregon; University of Pittsburgh Magee Womens Hospital, Pittsburgh, Pennsylvania; Brown University, Providence, Rhode Island; University of Texas - Southwest, Dallas, Texas; University of Texas-Houston, Houston, Texas; University of Texas Medical Branch - Galveston, Texas; and the University of Utah Medical Center, Salt Lake City, Utah.
  • If you are interested in participating, first talk to your health care provider to determine whether this clinical trial is right for you.
  • Get in touch with the study's contact person in your area to enroll in the study.
  • Be sure to refer to the trial's ClinicalTrials.gov identifier number: NCT00388297

Should You Participate?

Only you and your doctor can decide, but you may wish to read Mary Shomon's editorial on the subject.

Mary Shomon, About.com's Thyroid Guide since 1997, is a nationally-known patient advocate and best-selling author of 10 books on health, including "The Thyroid Hormone Breakthrough: Overcoming Sexual and Hormonal Problems at Every Age," "The Thyroid Diet: Manage Your Metabolism for Lasting Weight Loss," "Living Well With Hypothyroidism: What Your Doctor Doesn't Tell You...That You Need to Know," "Living Well With Graves' Disease and Hyperthyroidism," "Living Well With Autoimmune Disease," and "Living Well With Chronic Fatigue Syndrome and Fibromyalgia." Click here for more information on Mary Shomon. Sources

Alexander, Erik. "Timing and Magnitude of Increases in Levothyroxine Requirements during Pregnancy in Women with Hypothyroidism." New England Journal of Medicine, Volume 35107/15/2004 241-249. <http://content.nejm.org/cgi/content/short/351/3/241>.

"Statement on Early Maternal Thyroidal Insufficiency: Recognition, Clinical Management and Research Directions," American Thyroid Association (ATA), April 26, 2004 <http://www.thyroid.org/professionals/publications/statements/04_04_26_maternalthyroidal.htm l>

Kooistra, Libbe, PhD et. al. "Neonatal Effects of Maternal Hypothyroxinemia During Early Pregnancy" Pediatrics, Vol. 117 No. 1 January 2006, pp. 161-167

National Institute of Child Health and Human Development, Maternal Fetal Medicine Units Network, Study Description, <http://www.bsc.gwu.edu/mfmu/Projects/brieftrl.cgi>

"Thyroid Therapy for Mild Thyroid Deficiency in Pregnancy," Clinicaltrials.gov, <http://www.clinicaltrials.gov/ct/show/NCT00388297;jsessionidBF64497FA0B249A88F223EA 13D593C63?order2>

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