Postpartum Thyroid Measures and Mood

This study has been completed.
Sponsor:
Information provided by:
Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier:
NCT00565032
First received: November 27, 2007
Last updated: January 26, 2010
Last verified: January 2010
  Purpose

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.


Condition
Postpartum Depression

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postpartum Thyroid Measures and Mood

Resource links provided by NLM:


Further study details as provided by Oklahoma State University Center for Health Sciences:

Primary Outcome Measures:
  • Numerical score on the Edinburgh Postnatal Depression Scale [ Time Frame: seven weeks ]

Enrollment: 75
Study Start Date: January 2000
Study Completion Date: August 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  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: NCT00565032

Locations
United States, Oklahoma
Oklahoma State University Center for Health Sciences Houston Park Obstetrics Clinic
Tulsa, Oklahoma, United States, 74107
Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
Investigators
Study Director: Gary H. Watson, PhD Philadelphia College of Osteopathic Medicine Georgia Campus
  More Information

No publications provided by Oklahoma State University Center for Health Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00565032     History of Changes
Other Study ID Numbers: 9899015
Study First Received: November 27, 2007
Last Updated: January 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Oklahoma State University Center for Health Sciences:
postpartum depression
thyroxine
thyroid antibodies
thyroid stimulating hormone
Edinburgh Postnatal Depression Scale (EPDS)

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications

ClinicalTrials.gov processed this record on July 20, 2014