Postpartum Thyroid Measures and Mood

Postpartum Depression Clinical Trial

Official title:

Postpartum Thyroid Measures and Mood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00565032
• Other study ID #: 9899015
• Status: Completed
• Phase: N/A
• First received: November 27, 2007
• Last updated: January 26, 2010
• Start date: January 2000
• Est. completion date: August 2001

Study information

• Verified date: January 2010
• Source: Oklahoma State University Center for Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Postpartum Depression

Locations

Country	Name	City	State
United States	Oklahoma State University Center for Health Sciences Houston Park Obstetrics Clinic	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Oklahoma State University Center for Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical score on the Edinburgh Postnatal Depression Scale		seven weeks