Trial | NCT00846755  Report issue

Title

Thyroid Disease in Pregnancy: Case Finding Versus Universal Screening
Impact of Treating Thyroid Hormone Dysfunction During Pregnancy: A Randomized Controlled Trial of Universal Screening Versus Case Finding

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    4657
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.
Study Started
Mar 31
2005
Primary Completion
Mar 31
2008
Study Completion
Dec 31
2008
Last Update
Sep 27
2011
Estimate

Drug Levothyroxine, Propylthiouracile

Drugs were titrated to render euthyroid pregnant patients with thyroid disease

  • Other names: Levothyroxine, Propylthiouracile

Levothyroxine, Propylthiouracil Active Comparator

Drugs for the treatment of thyroid disease, are administered, when necessary, in high risk women, either in case finding, or in Universal Screening Group

clinical checks No Intervention

Low risk women whose sera are tested postpartum. Then patients with undiagnosed thyroid disease, are not treated

Criteria 

Inclusion Criteria:

Pregnant women
Within 11 week of gestation

Exclusion Criteria:

Already known thyroid disease
No Results Posted