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Thyroid Disease in Pregnancy: Case Finding Versus Universal Screening

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Roberto Negro, Ospedale V. Fazzi
ClinicalTrials.gov Identifier:
NCT00846755
First received: February 18, 2009
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention
Thyroid Disease
Pregnancy
Drug: Levothyroxine, Propylthiouracile

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Treating Thyroid Hormone Dysfunction During Pregnancy: A Randomized Controlled Trial of Universal Screening Versus Case Finding

Resource links provided by NLM:


Further study details as provided by Ospedale V. Fazzi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of the efficacy of Case Finding and Screening strategy [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Intelligence Quotient [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    •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)


Enrollment: 4657
Study Start Date: March 2005
Study Completion Date: December 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Levothyroxine, Propylthiouracil
Drugs for the treatment of thyroid disease, are administered, when necessary, in high risk women, either in case finding, or in Universal Screening Group
Drug: Levothyroxine, Propylthiouracile
Drugs were titrated to render euthyroid pregnant patients with thyroid disease
Other Names:
  • Levothyroxine
  • Propylthiouracile
No Intervention: clinical checks
Low risk women whose sera are tested postpartum. Then patients with undiagnosed thyroid disease, are not treated

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women
  • Within 11 week of gestation

Exclusion Criteria:

  • Already known thyroid disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846755

Locations
Italy
"V. Fazzi" Hospital
Lecce, Italy, 73100
Sponsors and Collaborators
Ospedale V. Fazzi
Investigators
Principal Investigator: Roberto Negro, Dr "V. Fazzi" Hospital
  More Information

No publications provided by Ospedale V. Fazzi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Roberto Negro, MD, Ospedale V. Fazzi
ClinicalTrials.gov Identifier: NCT00846755     History of Changes
Other Study ID Numbers: LE-1126-IT
Study First Received: February 18, 2009
Last Updated: September 26, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by Ospedale V. Fazzi:
Thyroid
Pregnancy

Additional relevant MeSH terms:
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on November 20, 2014