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Thyroid Disease in Pregnancy: Case Finding Versus Universal Screening

Information source: Ospedale V. Fazzi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Thyroid Disease; Pregnancy

Intervention: Levothyroxine, Propylthiouracile (Drug)

Phase: N/A

Status: Completed

Sponsored by: Ospedale V. Fazzi

Official(s) and/or principal investigator(s):
Roberto Negro, Dr, Principal Investigator, Affiliation: "V. Fazzi" Hospital

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

Clinical Details

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

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

Primary outcome: 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:

Evaluation of the efficacy of Case Finding and Screening strategy

Intelligence Quotient

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Pregnant women

- Within 11 week of gestation

Exclusion Criteria:

- Already known thyroid disease

Locations and Contacts

"V. Fazzi" Hospital, Lecce 73100, Italy
Additional Information

Starting date: March 2005
Last updated: September 26, 2011

Page last updated: August 23, 2015

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