Thyroid Disease in Pregnancy: Case Finding Versus Universal Screening

• Evaluation of the efficacy of Case Finding and Screening strategy [ Time Frame: 4 years ] [ Designated as safety issue: No ]
• Intelligence Quotient [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  •Intellectual function of children at 6 years of age, as measured by the Wechsler Intelligence Scale for Children (WISC) III, in women with a)hypothyroidism, left untreated because belonging to Case Finding Low Risk Group, b) hypothyroidism, treated with levothyroxine because belonging to Universal Screening High Risk and Low Risk Groups, and in Case Finding High Risk Group, and c)euthyroidism (control group)

The purpose of this study is to determine whether treatment of thyroid disease during pregnancy decrease the incidence of adverse outcome, and to compare the impact of Universal Screening versus case Finding strategy in detecting thyroid dysfunction

Thyroid disease during pregnancy has been associated with multiple adverse outcomes including miscarriage, preterm delivery, postpartum thyroiditis and decreased IQ in the offspring. Whether or not all women should be screened for thyroid disease during pregnancy (Universal Screening), screening should be confined to women at high risk for thyroid disease (Case Finding), or no screening should occur is controversial. For this purpose, pregnant women in the first trimester are randomly assigned to the Screening group or Case finding group. All women in the Screening group and high-risk women in the Case Finding group are immediately tested for FT4, TSH and TPO antibodies. Low-risk women in the Case Finding group have their sera tested postpartum. levothyroxine or PTU are given in hypothyroid and hyperthyroid women respectively. Outcome Measure: total number of adverse events occurring during pregnancy and in the neonatal period controlling for clustering of outcomes within women.

• Thyroid Disease
• Pregnancy

• Active Comparator: Levothyroxine, Propylthiouracil
  Drugs for the treatment of thyroid disease, are administered, when necessary, in high risk women, either in case finding, or in Universal Screening Group
  Intervention: Drug: Levothyroxine, Propylthiouracile
• No Intervention: clinical checks
  Low risk women whose sera are tested postpartum. Then patients with undiagnosed thyroid disease, are not treated

• Negro R, Schwartz A, Gismondi R, Tinelli A, Mangieri T, Stagnaro-Green A. Thyroid antibody positivity in the first trimester of pregnancy is associated with negative pregnancy outcomes. J Clin Endocrinol Metab. 2011 Jun;96(6):E920-4. Epub 2011 Mar 16.
• Stagnaro-Green A, Schwartz A, Gismondi R, Tinelli A, Mangieri T, Negro R. High rate of persistent hypothyroidism in a large-scale prospective study of postpartum thyroiditis in southern Italy. J Clin Endocrinol Metab. 2011 Mar;96(3):652-7. Epub 2010 Dec 29.

Inclusion Criteria:

• Pregnant women
• Within 11 week of gestation

Exclusion Criteria:

• Already known thyroid disease