Maternal Hypothyroidism in Pregnancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James Haddow, MD, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT00818896
First received: January 6, 2009
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

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.


Condition
Hypothyroidism

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Model Statewide Trial to Detect and Treat Maternal Hypothyroidism in Pregnancy

Resource links provided by NLM:


Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • Percent of women who develop permanent hypothyroidism. [ Time Frame: Up to two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of women with post-partum thyroid dysfunction. [ Time Frame: Up to two years ] [ Designated as safety issue: No ]

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.


Enrollment: 72
Study Start Date: April 2008
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Detailed Description:

This is a model community-based trial in Rhode Island (RI), aimed at avoiding or minimizing morbidity from overt maternal hypothyroidism by systematic detection and treatment, beginning at the 1st prenatal visit. This model can be superimposed on existing prenatal screening programs and is intended ultimately to replace "case-finding", which has recently been shown ineffective. Three aspects of maternal and child health are compromised when a pregnant woman is thyroid deficient: 1) the woman's own health and well-being; 2) her baby's brain development; and 3) overall health of the pregnancy (e.g., fetal death, prematurity, preeclampsia). Thyroid stimulating hormone (TSH) measurement, a well accepted indicator of thyroid dysfunction, will serve as the primary test for both diagnosis and monitoring. A TSH value >10 mU/L indicates overt hypothyroidism. Among the state's 14,000 annual pregnancies, 42 women (0.3%) will be overtly hypothyroid early in gestation (32 undiagnosed, and 10 under-treated). TSH values between 4.5 mU/L (98th centile) and 9.9 mU/L indicate subclinical hypothyroidism. The 240 women in this category will also receive treatment, and information will be gathered about disease progression to inform future practice. Approximately half of all RI's pregnancies are cared for by practices in Greater Providence, and TSH testing will initially be introduced, there. The research component is also within that area. Testing will subsequently be extended to the entire state. The program is centrally managed by three units at Women and Infants Hospital, in consultation with RI's Birth Defects Program Director. Program goals are to: provide TSH testing to at least 70% of pregnant women in Greater Providence; provide TSH testing to at least 50% of pregnant women elsewhere in RI; test 70% of screened women by 12 weeks' gestation, and 90% by 18 weeks' gestation; begin treatment in Greater Providence by 13 weeks' in 70%, and by 19 weeks' in 90%; document successful treatment during pregnancy in 90% (TSH >0.1 mU/L and <2.0 mU/L; retain 95% treated women to end of pregnancy, and 90% for up to 1 year postpartum; obtain pregnancy complications and birth outcomes for the entire cohort (Vital Records).

Data will be collected on participation by practices and women, % of women with undiagnosed thyroid deficiency, compliance with follow-up and treatment during pregnancy and for up to one year afterwards, outcomes of their pregnancies, % of hypothyroid women with postpartum thyroid dysfunction, % of women with subclinical hypothyroidism who remain hypothyroid one year postpartum, physician attitudes, and program costs.

  Eligibility

Ages Eligible for Study:   17 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • TSH value >98th centile in early pregnancy

Exclusion Criteria:

  • Women with known hypothyroidism
  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: NCT00818896

Locations
United States, Rhode Island
Women & Infants Hospital
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Investigators
Principal Investigator: James E. Haddow, M.D. Women & Infants Hospital
  More Information

No publications provided

Responsible Party: James Haddow, MD, Dr. James Haddow, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT00818896     History of Changes
Other Study ID Numbers: IRB #08-0005, R18 DP001148
Study First Received: January 6, 2009
Last Updated: September 18, 2012
Health Authority: United States: Federal Government

Keywords provided by Women and Infants Hospital of Rhode Island:
thyroid deficiency
pregnancy
post-partum thyroid dysfunction
permanent hypothyroidism

Additional relevant MeSH terms:
Hypothyroidism
Endocrine System Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on October 21, 2014