Thyroid Disease in Pregnancy: Case Finding Versus Universal Screening
Primary Purpose
Thyroid Disease, Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Levothyroxine, Propylthiouracile
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Disease focused on measuring Thyroid, Pregnancy
Eligibility Criteria
Inclusion Criteria:
- Pregnant women
- Within 11 week of gestation
Exclusion Criteria:
- Already known thyroid disease
Sites / Locations
- "V. Fazzi" Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Levothyroxine, Propylthiouracil
clinical checks
Arm Description
Drugs for the treatment of thyroid disease, are administered, when necessary, in high risk women, either in case finding, or in Universal Screening Group
Low risk women whose sera are tested postpartum. Then patients with undiagnosed thyroid disease, are not treated
Outcomes
Primary Outcome Measures
number of adverse outcomes which occur during pregnancy and in the neonatal period in patients divided in Case Finding and Universal Screening groups
Secondary Outcome Measures
Evaluation of the efficacy of Case Finding and Screening strategy
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)
Full Information
NCT ID
NCT00846755
First Posted
February 18, 2009
Last Updated
September 26, 2011
Sponsor
Ospedale V. Fazzi
1. Study Identification
Unique Protocol Identification Number
NCT00846755
Brief Title
Thyroid Disease in Pregnancy: Case Finding Versus Universal Screening
Official Title
Impact of Treating Thyroid Hormone Dysfunction During Pregnancy: A Randomized Controlled Trial of Universal Screening Versus Case Finding
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale V. Fazzi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Disease, Pregnancy
Keywords
Thyroid, Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
4657 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levothyroxine, Propylthiouracil
Arm Type
Active Comparator
Arm Description
Drugs for the treatment of thyroid disease, are administered, when necessary, in high risk women, either in case finding, or in Universal Screening Group
Arm Title
clinical checks
Arm Type
No Intervention
Arm Description
Low risk women whose sera are tested postpartum. Then patients with undiagnosed thyroid disease, are not treated
Intervention Type
Drug
Intervention Name(s)
Levothyroxine, Propylthiouracile
Other Intervention Name(s)
Levothyroxine, Propylthiouracile
Intervention Description
Drugs were titrated to render euthyroid pregnant patients with thyroid disease
Primary Outcome Measure Information:
Title
number of adverse outcomes which occur during pregnancy and in the neonatal period in patients divided in Case Finding and Universal Screening groups
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Evaluation of the efficacy of Case Finding and Screening strategy
Time Frame
4 years
Title
Intelligence Quotient
Description
•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)
Time Frame
6 years
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women
Within 11 week of gestation
Exclusion Criteria:
Already known thyroid disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Negro, Dr
Organizational Affiliation
"V. Fazzi" Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
"V. Fazzi" Hospital
City
Lecce
ZIP/Postal Code
73100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
21411559
Citation
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. doi: 10.1210/jc.2011-0026. Epub 2011 Mar 16.
Results Reference
derived
PubMed Identifier
21190974
Citation
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. doi: 10.1210/jc.2010-1980. Epub 2010 Dec 29.
Results Reference
derived
Learn more about this trial
Thyroid Disease in Pregnancy: Case Finding Versus Universal Screening
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