NCT00846755

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,657 (actual)
• Sponsor: Ospedale V. Fazzi · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Thyroid Disease
• Pregnancy

Interventions

Type	Name	Description
DRUG	Levothyroxine, Propylthiouracile	Drugs were titrated to render euthyroid pregnant patients with thyroid disease

Timeline

• Start date: 2005-03-01
• Primary completion: 2008-03-01
• Completion: 2008-12-01
• First posted: 2009-02-19
• Last updated: 2011-09-27

Locations

1 site across 1 country: Italy