Postpartum Thyroid Measures and Mood

January 26, 2010 updated by: Oklahoma State University Center for Health Sciences
Women with abnormal serum thyroid antibody levels or abnormal TSH and/or T4 values are more likely than their normal counterparts to have higher scores on a common postpartum depression screening test.

Study Overview

Status

Completed

Conditions

Detailed Description

This small pilot study was an attempt to corroborate a relationship between quantified mood and thyroid measures, using the numerical scores obtained from a common depression screen, the Edinburgh Postnatal Depression Scale (EPDS), as a continuum. Mood scores were compared with presence of thyroid autoantibodies and plasma concentrations of free T4 and TSH.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74107
        • Oklahoma State University Center for Health Sciences Houston Park Obstetrics Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Subjects were patients from two Oklahoma State University Center for Health Sciences (OSUCHS) clinics in Tulsa, Oklahoma.

Description

Inclusion Criteria:

  • Over 18 years of age
  • In third trimester of pregnancy when recruited

  • Negative for the following drugs detected by a urine drug screen:

    • Amphetamines
    • Barbiturates
    • Benzodiazepines
    • Cocaine
    • Opiates
    • Phencyclidine metabolites (PCP), and tricyclic antidepressants
    • Vaginal delivery
    • Screened negative for major depressive disorder on the Edinburgh Postnatal Depression Scale (EPDS) at her prenatal enrollment in the study
    • Receiving a score of 12 or lower out of a possible 30

Exclusion Criteria:

  • Under age 18

  • Positive for any of the following drugs:

    • Amphetamines
    • Barbiturates
    • Benzodiazepines
    • Cocaine
    • Opiates
    • Phencyclidine metabolites (PCP), and tricyclic antidepressants
    • Cesarean delivery
    • EPDS score over 12 at prenatal screening test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Numerical score on the Edinburgh Postnatal Depression Scale
Time Frame: seven weeks
seven weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oklahoma State University Center for Health Sciences

Investigators

  • Study Director: Gary H. Watson, PhD, Philadelphia College of Osteopathic Medicine Georgia Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Study Completion (Actual)

August 1, 2001

Study Registration Dates

First Submitted

November 27, 2007

First Submitted That Met QC Criteria

November 28, 2007

First Posted (Estimate)

November 29, 2007

Study Record Updates

Last Update Posted (Estimate)

January 28, 2010

Last Update Submitted That Met QC Criteria

January 26, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9899015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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