Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT03763435
Status:
UNKNOWN
Last Update Posted:
2019-04-23
First Post:
2018-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Pregnancy Classes and Contributing Factors to Postpartum Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D001942', 'term': 'Breast Feeding'}], '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'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-21', 'studyFirstSubmitDate': '2018-11-24', 'studyFirstSubmitQcDate': '2018-12-01', 'lastUpdatePostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postpartum Depression', 'timeFrame': 'Change between the 4th, 8th and 12th weeks of postpartum period', 'description': 'Postpartum Depression scores will be measured by Edinburgh Postpartum Scale (EDPS). The EDPS was developed to identify women who may have postpartum depression. Each answer is given a score of 0 to 3 . The maximum score is 30. The EPDS is a 10-item questionnaire. Women are asked to answer each question in terms of the past seven days. A score is calculated by adding the individual items as indicated A score of more than 10 suggests minor or major depression may be present.'}], 'secondaryOutcomes': [{'measure': 'Genital self-image', 'timeFrame': 'At 4th, 8th and 12th week of postpartum period', 'description': "Genital Self-image scores will be measured by Female Genital Self Image Scale (FGSIS). FGSIS measures the genital self-image of the participants.\n\nThe seven-item FGSIS assesses women's feelings and beliefs about their own genitals using a 4-point response scale (strongly agree, agree, disagree, strongly disagree).\n\nRespondents'scores on each item were summed for a total sum score ranging from 7 to 28, with higher scores indicating more positive genital self-image."}, {'measure': 'sleep disorders', 'timeFrame': 'At 4th, 8th and 12th week of postpartum period', 'description': 'Sleep problems will be measured by Insomnia Severity Index (ISI). The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).'}, {'measure': 'breast-feeding', 'timeFrame': 'At 4th, 8th and 12th week of postpartum period', 'description': 'Breast-feeding will be assessed by the Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF). It is a 14 item self-report instrument developed to measure a mother\'s perceived ability to breastfeed her infant. It has a five-point Likert scale for rating from 1 ("not at all confident") to 5 ("always confident"). Items ratings will be summed to produce a total score from 14 to 70, with higher scores indicating higher confidence. The means score points will be used as the cut-off point between high and low scorers.'}, {'measure': 'socio-economic-demographical features', 'timeFrame': 'At 4th postpartum week', 'description': 'Social, economic and demographic features will be assessed by a structured non-validated data gathering form'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postpartum depression', 'sleep disorder', 'genital self-image', 'breast-feeding', 'prevalence'], 'conditions': ['Postpartum Depression', 'Sleep Disorder', 'Breast Feeding', 'Self Esteem']}, 'referencesModule': {'references': [{'pmid': '21569372', 'type': 'BACKGROUND', 'citation': 'Lanes A, Kuk JL, Tamim H. Prevalence and characteristics of postpartum depression symptomatology among Canadian women: a cross-sectional study. BMC Public Health. 2011 May 11;11:302. doi: 10.1186/1471-2458-11-302.'}]}, 'descriptionModule': {'briefSummary': "It is recommended by the American College of Obstetricians and Gynecologists' Committee on Obstetric Practice that all obstetricians screen each women for postpartum depression and anxiety with a validated instrument. Although much effort is made, the contributing factors still lack in the literature due to its multi-factorial nature and complexity.\n\nIn addition, the effects of prenatal education classes remain understudied. Therefore, this study aims to demonstrate the prevalence, characteristics and contributing factors of the postpartum depression. In addition, the change in prevalence and characteristics of the postpartum depression among women who had prenatal classes and not will also be assessed.", 'detailedDescription': 'Specific and validated instruments will be performed to women in their 8th week of postpartum period.\n\nThose instruments are:\n\nEdinburgh Postpartum Depression Scale (EPDS) Female genital self-image scale (FGSIS) Insomnia Severity Index (ISI) Breast-feeding efficacy scale short form (BSES-SF) Beck Depression Scale'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All women who gave birth in Bartin State Hospital (the only one hospital in the city) after October 2018. for three months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women in the puerpera period (who gave consent)\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT03763435', 'briefTitle': 'The Effects of Pregnancy Classes and Contributing Factors to Postpartum Depression', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bartin State Hospital'}, 'officialTitle': 'The Effects of Pregnancy Classes on Postpartum Depression and Contributing Factors to Postpartum Depression', 'orgStudyIdInfo': {'id': 'Bartin2018-3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Antenatal Classes Received', 'description': 'Women who are involved into at least 3 comprehensive session of Antenatal pregnancy classes (educational) during the prenatal period.', 'interventionNames': ['Behavioral: Antenatal pregnancy classes']}, {'label': 'Without education', 'description': 'Groups are not randomized for not to give rise to ethical problems in order to maximize the community health care. Only women who are not involved into the educational classes due to their inaccessibility related to their own conditions or wishes.'}], 'interventions': [{'name': 'Antenatal pregnancy classes', 'type': 'BEHAVIORAL', 'description': 'At least three comprehensive full-day educational program covering all the stages of pregnancy.', 'armGroupLabels': ['Antenatal Classes Received']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bartın', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Murat Yassa, MD', 'role': 'CONTACT'}, {'name': 'Nahide YAZICI, Midwife', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Bartin State Hospital', 'geoPoint': {'lat': 41.63583, 'lon': 32.3375}}], 'centralContacts': [{'name': 'Murat Yassa, MD', 'role': 'CONTACT', 'email': 'murat.yassa@gmail.com', 'phone': '+905335106312'}], 'overallOfficials': [{'name': 'Murat Yassa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bartin State Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bartin State Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Murat Yassa', 'investigatorAffiliation': 'Bartin State Hospital'}}}}