NCT00846755

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,657

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
Last Updated

September 27, 2011

Status Verified

September 1, 2011

Enrollment Period

3 years

First QC Date

February 18, 2009

Last Update Submit

September 26, 2011

Conditions

Thyroid DiseasePregnancy

Keywords

ThyroidPregnancy

Outcome Measures

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

    9 months

Secondary Outcomes (2)

  • Evaluation of the efficacy of Case Finding and Screening strategy

    4 years

  • Intelligence Quotient

    6 years

Study Arms (2)

Levothyroxine, Propylthiouracil

ACTIVE COMPARATOR

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

clinical checks

NO INTERVENTION

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

Interventions

Levothyroxine, PropylthiouracileDRUG

Drugs were titrated to render euthyroid pregnant patients with thyroid disease

Also known as: Levothyroxine, Propylthiouracile
Levothyroxine, Propylthiouracil

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women
  • Within 11 week of gestation

You may not qualify if:

  • Already known thyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"V. Fazzi" Hospital

Lecce, 73100, Italy

Location

Related Publications (2)

  • 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.

    PMID: 21411559DERIVED

  • 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.

    PMID: 21190974DERIVED

MeSH Terms

Conditions

Thyroid Diseases

Interventions

ThyroxinePropylthiouracil

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsThiouracilUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Roberto Negro, Dr

    "V. Fazzi" Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 18, 2009

First Posted

February 19, 2009

Study Start

March 1, 2005

Primary Completion

March 1, 2008

Study Completion

December 1, 2008

Last Updated

September 27, 2011

Record last verified: 2011-09

Locations

IT(1)