Maternal Hypothyroidism in Pregnancy
Maternal Hypothyroidism in Pregnancy
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.
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 weeks' in 70%, and by 19 weeks' in 90%; document successful
 treatment during pregnancy in 90% (TSH >0.1 mU/L and <2.0 mU/L; retain 95% treated women to
 end of pregnancy, and 90% for up to 1 year postpartum; obtain pregnancy complications and
 birth outcomes for the entire cohort (Vital Records).

 Data will be collected on participation by practices and women, % of women with undiagnosed
 thyroid deficiency, compliance with follow-up and treatment during pregnancy and for up to
 one year afterwards, outcomes of their pregnancies, % of hypothyroid women with postpartum
 thyroid dysfunction, % of women with subclinical hypothyroidism who remain hypothyroid one
 year postpartum, physician attitudes, and program costs.
Inclusion Criteria:

 -  TSH value >98th centile in early pregnancy

 Exclusion Criteria:

 -  Women with known hypothyroidism