Thyroid Disease in Pregnancy: Case Finding Versus Universal Screening
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Purpose
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
| Condition | Intervention |
|---|---|
|
Thyroid Disease Pregnancy |
Drug: Levothyroxine, Propylthiouracile |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Impact of Treating Thyroid Hormone Dysfunction During Pregnancy: A Randomized Controlled Trial of Universal Screening Versus Case Finding |
- 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 ] [ Designated as safety issue: No ]
- Evaluation of the efficacy of Case Finding and Screening strategy [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Intelligence Quotient [ Time Frame: 6 years ] [ Designated as safety issue: No ]•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)
| Enrollment: | 4657 |
| Study Start Date: | March 2005 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Levothyroxine, Propylthiouracil
Drugs for the treatment of thyroid disease, are administered, when necessary, in high risk women, either in case finding, or in Universal Screening Group
|
Drug: Levothyroxine, Propylthiouracile
Drugs were titrated to render euthyroid pregnant patients with thyroid disease
Other Names:
|
|
No Intervention: clinical checks
Low risk women whose sera are tested postpartum. Then patients with undiagnosed thyroid disease, are not treated
|
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Pregnant women
- Within 11 week of gestation
Exclusion Criteria:
- Already known thyroid disease
Contacts and Locations
More Information
No publications provided by Ospedale V. Fazzi
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Roberto Negro, MD, Ospedale V. Fazzi |
| ClinicalTrials.gov Identifier: | NCT00846755 History of Changes |
| Other Study ID Numbers: | LE-1126-IT |
| Study First Received: | February 18, 2009 |
| Last Updated: | September 26, 2011 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Ospedale V. Fazzi:
|
Thyroid Pregnancy |
Additional relevant MeSH terms:
|
Thyroid Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013