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Thyroid Disease in Pregnancy: Case Finding Versus Universal Screening

NCT ID: NCT00846755

Last Updated: 2011-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4657 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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

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Thyroid Disease Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Levothyroxine, Propylthiouracile

Intervention Type DRUG

Drugs were titrated to render euthyroid pregnant patients with thyroid disease

clinical checks

Low risk women whose sera are tested postpartum. Then patients with undiagnosed thyroid disease, are not treated

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Levothyroxine, Propylthiouracile

Drugs were titrated to render euthyroid pregnant patients with thyroid disease

Intervention Type DRUG

Other Intervention Names

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Levothyroxine Propylthiouracile

Eligibility Criteria

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Inclusion Criteria

* Pregnant women
* Within 11 week of gestation

Exclusion Criteria

* Already known thyroid disease
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ospedale V. Fazzi

OTHER

Sponsor Role lead

Responsible Party

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Dr. Roberto Negro

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roberto Negro, Dr

Role: PRINCIPAL_INVESTIGATOR

"V. Fazzi" Hospital

Locations

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"V. Fazzi" Hospital

Lecce, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 21411559 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21190974 (View on PubMed)

Other Identifiers

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LE-1126-IT

Identifier Type: -

Identifier Source: org_study_id