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Completed

NCT Number: NCT00846755

Thyroid Disease in Pregnancy: Case Finding Versus Universal Screening

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

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Key information

Conditions

Thyroid Disease Endocrine System Diseases Pregnancy Thyroid Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

"V. Fazzi" Hospital

Lecce, 73100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women
  • Within 11 week of gestation

Exclusion criteria

  • Already known thyroid disease

Treatment and study plan

Levothyroxine, Propylthiouracile

Drug

Drugs were titrated to render euthyroid pregnant patients with thyroid disease

Other names: Levothyroxine, Propylthiouracile

Primary outcomes

  1. number of adverse outcomes which occur during pregnancy and in the neonatal period in patients divided in Case Finding and Universal Screening groups

    Time frame: 9 months

Secondary outcomes

  1. Evaluation of the efficacy of Case Finding and Screening strategy

    Time frame: 4 years

  2. Intelligence Quotient

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Ospedale V. Fazzi

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Feb 19, 2009
Registry last updated
Sep 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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