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Postpartum Thyroid Measures and Mood

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ClinicalTrials.gov Identifier: NCT00565032
Recruitment Status : Completed
First Posted : November 29, 2007
Last Update Posted : January 28, 2010
Sponsor:
Information provided by:
Oklahoma State University Center for Health Sciences

Brief Summary:
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 or disease
Postpartum Depression

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
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postpartum Thyroid Measures and Mood
Study Start Date : January 2000
Actual Study Completion Date : August 2001

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid
U.S. FDA Resources




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00565032     History of Changes
Other Study ID Numbers: 9899015
First Posted: November 29, 2007    Key Record Dates
Last Update Posted: January 28, 2010
Last Verified: January 2010

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
Depression, Postpartum
Behavioral Symptoms
Puerperal Disorders
Pregnancy Complications
Depressive Disorder
Mood Disorders
Mental Disorders