Thyroid Disease in Pregnancy: Case Finding Versus Universal Screening

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00846755
• Other study ID #: LE-1126-IT
• Status: Completed
• Phase: N/A
• First received: February 18, 2009
• Last updated: September 26, 2011
• Start date: March 2005
• Est. completion date: December 2008

Study information

• Verified date: September 2011
• Source: Ospedale V. Fazzi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4657
• Est. completion date: December 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant women

• Within 11 week of gestation

Exclusion Criteria:

• Already known thyroid disease

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy
• Thyroid Disease
• Thyroid Diseases

Intervention

Drug:
• Levothyroxine, Propylthiouracile
Drugs were titrated to render euthyroid pregnant patients with thyroid disease

Locations

Country	Name	City	State
Italy	"V. Fazzi" Hospital	Lecce

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale V. Fazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluation of the efficacy of Case Finding and Screening strategy		4 years	No
Secondary	Intelligence Quotient	•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)	6 years	No