Clinical trial NCT00846755: 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
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Disease
Pregnancy
Keywords: Thyroid
Pregnancy
Lead sponsor: Ospedale V. Fazzi
Sponsor class: OTHER
First posted: 2009-02-19
Enrollment: 4657
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Pregnant women
* Within 11 week of gestation

Exclusion Criteria:

* Already known thyroid disease

Primary outcomes:
measure: number of adverse outcomes which occur during pregnancy and in the neonatal period in patients divided in Case Finding and Universal Screening groups
timeFrame: 9 months
Secondary outcomes:
measure: Evaluation of the efficacy of Case Finding and Screening strategy
timeFrame: 4 years
measure: Intelligence Quotient
timeFrame: 6 years
Other outcomes:
Locations:
city: Lecce
country: Italy
facility: "V. Fazzi" Hospital
Study officials:
affiliation: "V. Fazzi" Hospital
name: Roberto Negro, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.