Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-02-02 @ 5:17 AM
Study NCT ID:
NCT00565032
Status:
COMPLETED
Last Update Posted:
2010-01-28
First Post:
2007-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postpartum Thyroid Measures and Mood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2001-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-26', 'studyFirstSubmitDate': '2007-11-27', 'studyFirstSubmitQcDate': '2007-11-28', 'lastUpdatePostDateStruct': {'date': '2010-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical score on the Edinburgh Postnatal Depression Scale', 'timeFrame': 'seven weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['postpartum depression', 'thyroxine', 'thyroid antibodies', 'thyroid stimulating hormone', 'Edinburgh Postnatal Depression Scale (EPDS)'], 'conditions': ['Postpartum Depression']}, 'referencesModule': {'references': [{'pmid': '18806079', 'type': 'DERIVED', 'citation': 'McCoy SJ, Beal JM, Payton ME, Stewart AL, DeMers AM, Watson GH. Postpartum thyroid measures and depressive symptomology: a pilot study. J Am Osteopath Assoc. 2008 Sep;108(9):503-7.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects were patients from two Oklahoma State University Center for Health Sciences (OSUCHS) clinics in Tulsa, Oklahoma.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years of age\n* In third trimester of pregnancy when recruited\n* Negative for the following drugs detected by a urine drug screen:\n\n * Amphetamines\n * Barbiturates\n * Benzodiazepines\n * Cocaine\n * Opiates\n * Phencyclidine metabolites (PCP), and tricyclic antidepressants\n * Vaginal delivery\n * Screened negative for major depressive disorder on the Edinburgh Postnatal Depression Scale (EPDS) at her prenatal enrollment in the study\n * Receiving a score of 12 or lower out of a possible 30\n\nExclusion Criteria:\n\n* Under age 18\n* Positive for any of the following drugs:\n\n * Amphetamines\n * Barbiturates\n * Benzodiazepines\n * Cocaine\n * Opiates\n * Phencyclidine metabolites (PCP), and tricyclic antidepressants\n * Cesarean delivery\n * EPDS score over 12 at prenatal screening test'}, 'identificationModule': {'nctId': 'NCT00565032', 'briefTitle': 'Postpartum Thyroid Measures and Mood', 'organization': {'class': 'OTHER', 'fullName': 'Oklahoma State University Center for Health Sciences'}, 'officialTitle': 'Postpartum Thyroid Measures and Mood', 'orgStudyIdInfo': {'id': '9899015'}}, 'contactsLocationsModule': {'locations': [{'zip': '74107', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma State University Center for Health Sciences Houston Park Obstetrics Clinic', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}], 'overallOfficials': [{'name': 'Gary H. Watson, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Philadelphia College of Osteopathic Medicine Georgia Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oklahoma State University Center for Health Sciences', 'class': 'OTHER'}}}}