Thyroid Disease in Pregnancy: Case Finding Versus Universal Screening

Not Applicable

Completed

• Conditions: Thyroid Disease; Pregnancy
• Interventions: Drug: Levothyroxine, Propylthiouracile

• Registration Number: NCT00846755
• Lead Sponsor: Ospedale V. Fazzi

Brief 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.

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2008-03
• Study Completion: 2008-12
• Study First Submitted: 2009-02-18
• Study First Submitted QC: 2009-02-18
• Study First Posted: 2009-02-19
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-26
• Last Update Posted: 2011-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4657

Inclusion Criteria

• Pregnant women
• Within 11 week of gestation

Exclusion Criteria

• Already known thyroid disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
number of adverse outcomes which occur during pregnancy and in the neonatal period in patients divided in Case Finding and Universal Screening groups	9 months

Secondary Outcome Measures

Name	Time	Method
Evaluation of the efficacy of Case Finding and Screening strategy	4 years
Intelligence Quotient	6 years	•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)

Trial Locations

Locations (1)

"V. Fazzi" Hospital; 🇮🇹 Lecce, Italy