Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT04278456
Status:
UNKNOWN
Last Update Posted:
2020-02-20
First Post:
2020-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postpartum Depression
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-07-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2020-02-18', 'studyFirstSubmitQcDate': '2020-02-18', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'edinburgh depression scale', 'timeFrame': '5 months', 'description': 'below 12 is associated with depression'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postpartum Depression', 'Melatonin']}, 'referencesModule': {'references': [{'pmid': '24835540', 'type': 'RESULT', 'citation': 'Andersen LP, Werner MU, Rosenberg J, Gogenur I. A systematic review of peri-operative melatonin. Anaesthesia. 2014 Oct;69(10):1163-71. doi: 10.1111/anae.12717. Epub 2014 May 19.'}, {'pmid': '24015137', 'type': 'RESULT', 'citation': 'Maitra S, Baidya DK, Khanna P. Melatonin in perioperative medicine: Current perspective. Saudi J Anaesth. 2013 Jul;7(3):315-21. doi: 10.4103/1658-354X.115316.'}, {'pmid': '26697084', 'type': 'RESULT', 'citation': 'Dianatkhah M, Ghaeli P, Hajhossein Talasaz A, Karimi A, Salehiomran A, Bina P, Jalali A, Ghaffary S, Shahmansouri N, Vejdani S. Evaluating the Potential Effect of Melatonin on the post-Cardiac Surgery Sleep Disorder. J Tehran Heart Cent. 2015 Jul 3;10(3):122-8.'}]}, 'descriptionModule': {'briefSummary': 'Our aim was to diagnose and initiate early treatment for postpartum depression by detecting the changes of melatonin levels in c-sections with different antesthesia modalities.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women that will give birth by c-section (using general or regional anesthesia) aged between 18-45 years will be included to our study', 'genderDescription': 'aged between 18-45 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women c-section (using general or regional anesthesia) aged between 18-45 years\n\nExclusion Criteria:\n\n* age under 18 or above 45, history of smoking, a diagnosis with mental retardation, psychiatric patients, use of antipsychotics or antidepressants, patients with sleeping disorders, hormone replacement theraphy patients.'}, 'identificationModule': {'nctId': 'NCT04278456', 'briefTitle': 'Postpartum Depression', 'organization': {'class': 'OTHER', 'fullName': 'Erzincan University'}, 'officialTitle': 'The Effect of the Anesthesia Modality Used in Women Giving Birth Under Caesarian Section on Postpartum Depression and/or Postoperative Melatonin Levels', 'orgStudyIdInfo': {'id': 'EBYU 88'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'general anesthesia', 'description': 'c-section with general anesthesia', 'interventionNames': ['Behavioral: postpartum depression']}, {'label': 'spinal anesthesia', 'description': 'c-section with spinal anesthesia', 'interventionNames': ['Behavioral: postpartum depression']}, {'label': 'epidural anesthesia', 'description': 'c-section with epidural anesthesia', 'interventionNames': ['Behavioral: postpartum depression']}], 'interventions': [{'name': 'postpartum depression', 'type': 'BEHAVIORAL', 'description': 'melatonin levels in c-sections with different anesthesia modalities.', 'armGroupLabels': ['epidural anesthesia', 'general anesthesia', 'spinal anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Erzincan', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'DİDEM ONK', 'role': 'CONTACT', 'email': 'd.hesapdar@gmail.com', 'phone': '05053856322'}], 'facility': 'Erzincan Byu', 'geoPoint': {'lat': 39.73919, 'lon': 39.49015}}], 'centralContacts': [{'name': 'DİDEM ONK', 'role': 'CONTACT', 'email': 'd.hesapdar@gmail.com', 'phone': '05053856322'}], 'overallOfficials': [{'name': 'Remziye Ayşenur NALBANT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ERZİNCAN'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erzincan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'REMZIYE AYSENUR NALBANT', 'investigatorAffiliation': 'Erzincan University'}}}}