Maternal Hypothyroidism in Pregnancy

NCT00818896 | Completed DMC

• 2 other identifiers: IRB #08-0005R18DP001148
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

There is general agreement that thyroid gland function should be assessed in pregnant women. When the gland produces too little thyroid hormone (hypothyroidism), all of the woman's bodily functions slow down, and there are problems with her baby's development. Until now, physicians have identified this problem on an individual basis (case-finding), but this approach misses many of the cases. Our trial aims to replace case-finding with a routine blood test that is highly effective at detecting hypothyroidism, thereby allowing treatment to correct the deficiency. This approach can eventually be implemented throughout the United States.

Conditions

Hypothyroidism

Keywords

thyroid deficiency; pregnancy; post-partum thyroid dysfunction; permanent hypothyroidism

Outcome Measures

Primary Outcomes (1)

• Percent of women who develop permanent hypothyroidism.

  Up to two years

Secondary Outcomes (1)

• Percent of women with post-partum thyroid dysfunction.

  Up to two years

Eligibility Criteria

• Age: 17 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The subjects will be 176 pregnant women and adolescents discovered to have varying degrees of hypothyroidism during the first and early second trimesters. This disorder will be identified by a blood test offered as part of routine prenatal care in a CDC-sponsored community-based program at prenatal practices in Providence, Rhode Island. These 176 women all will receive appropriate treatment for their hypothyroidism, and permission will be sought to record information about the natural history of their condition during the first postpartum year, as a way to inform future practice. The women will range in age from about 17 to 44 years. Their racial/ethnic composition will reflect that of the general population of Rhode Island.

You may qualify if:

• TSH value \>98th centile in early pregnancy

You may not qualify if:

• Women with known hypothyroidism

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and urine samples from women who consent are to be stored in the freezer. Iodine measurements will be performed in urine samples and, possibly, serum samples. Consent is also asked for use of stored samples for other research purposes in the future.

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Study Officials

• James E. Haddow, M.D.

  Women & Infants Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. James Haddow

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: January 8, 2009
• Study Start: April 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 19, 2012

Record last verified: 2012-09

Locations

US (1)