Pregnancy, Thyroid Disease
Conditions
Keywords
Thyroid, Pregnancy
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.
Interventions
DRUGLevothyroxine, Propylthiouracile
Drugs were titrated to render euthyroid pregnant patients with thyroid disease
Sponsors
Ospedale V. Fazzi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women * Within 11 week of gestation
Exclusion criteria
* Already known thyroid disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of adverse outcomes which occur during pregnancy and in the neonatal period in patients divided in Case Finding and Universal Screening groups | 9 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the efficacy of Case Finding and Screening strategy | 4 years | — |
| Intelligence Quotient | 6 years | •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) |
Countries
Italy
Outcome results
None listed