Thyroid Disease in Pregnancy: Case Finding Versus Universal Screening

Ospedale V. Fazzi

Status: Completed

Conditions: Thyroid Disease; Pregnancy

Treatments: Drug: Levothyroxine, Propylthiouracile

Study type: Interventional

Funder types: Other

Identifiers

NCT00846755

LE-1126-IT

Details and patient eligibility

About

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

Full 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.

Enrollment: 4,657 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women
• Within 11 week of gestation

Exclusion criteria

• Already known thyroid disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4,657 participants in 2 patient groups

Levothyroxine, Propylthiouracil

Active Comparator group

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

Treatment:

Drug: Levothyroxine, Propylthiouracile

clinical checks

No Intervention group

Description:

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