Clinical Trial: Maternal Hypothyroidism in Pregnancy

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Model Statewide Trial to Detect and Treat Maternal Hypothyroidism in Pregnancy

Brief Summary: There is general agreement that thyroid gland function should be assessed in pregnant women. When the gland produces too little thyroid hormone (hypothyroidism), all of the woman's bodily functions slow down, and there are problems with her baby's development. Until now, physicians have identified this problem on an individual basis (case-finding), but this approach misses many of the cases. Our trial aims to replace case-finding with a routine blood test that is highly effective at detecting hypothyroidism, thereby allowing treatment to correct the deficiency. This approach can eventually be implemented throughout the United States.

Detailed Summary:

This is a model community-based trial in Rhode Island (RI), aimed at avoiding or minimizing morbidity from overt maternal hypothyroidism by systematic detection and treatment, beginning at the 1st prenatal visit. This model can be superimposed on existing prenatal screening programs and is intended ultimately to replace "case-finding", which has recently been shown ineffective. Three aspects of maternal and child health are compromised when a pregnant woman is thyroid deficient: 1) the woman's own health and well-being; 2) her baby's brain development; and 3) overall health of the pregnancy (e.g., fetal death, prematurity, preeclampsia). Thyroid stimulating hormone (TSH) measurement, a well accepted indicator of thyroid dysfunction, will serve as the primary test for both diagnosis and monitoring. A TSH value >10 mU/L indicates overt hypothyroidism. Among the state's 14,000 annual pregnancies, 42 women (0.3%) will be overtly hypothyroid early in gestation (32 undiagnosed, and 10 under-treated). TSH values between 4.5 mU/L (98th centile) and 9.9 mU/L indicate subclinical hypothyroidism. The 240 women in this category will also receive treatment, and information will be gathered about disease progression to inform future practice. Approximately half of all RI's pregnancies are cared for by practices in Greater Providence, and TSH testing will initially be introduced, there. The research component is also within that area. Testing will subsequently be extended to the entire state. The program is centrally managed by three units at Women and Infants Hospital, in consultation with RI's Birth Defects Program Director. Program goals are to: provide TSH testing to at least 70% of pregnant women in Greater Providence; provide TSH testing to at least 50% of pregnant women elsewhere in RI; test 70% of screened women by 12 weeks' gestation, and 90% by 18 weeks' gestation; begin treatment in Greater Providence by 13 week
Sponsor: Women and Infants Hospital of Rhode Island

Current Primary Outcome: Percent of women who develop permanent hypothyroidism. [ Time Frame: Up to two years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Percent of women with post-partum thyroid dysfunction. [ Time Frame: Up to two years ]

Original Secondary Outcome: Same as current

Information By: Women and Infants Hospital of Rhode Island

Dates:
Date Received: January 6, 2009
Date Started: April 2008
Date Completion:
Last Updated: September 18, 2012
Last Verified: September 2012