Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT05106634
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2021-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Breastfeeding Success and Self-Efficacy in Mothers Giving Birth Via Vaginal Delivery or Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2021-10-23', 'studyFirstSubmitQcDate': '2021-10-23', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breastfeeding success observing', 'timeFrame': 'Postpartum 24 hours', 'description': 'assessed using the LATCH Breastfeeding Assessment Tool'}, {'measure': 'Breastfeeding Self-Efficacy', 'timeFrame': 'Early postpartum period (after 24 hours)', 'description': 'assessed using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breastfeeding Success', 'breastfeeding Self-Efficacy', 'vaginal delivery', 'cesarean section', 'spinal anesthesia', 'general anesthesia', 'epidural anestezi'], 'conditions': ['Breastfeeding']}, 'referencesModule': {'references': [{'pmid': '24897921', 'type': 'BACKGROUND', 'citation': 'Alus Tokat M, Sercekus P, Yenal K, Okumus H. Early postpartum breast-feeding outcomes and breast-feeding self-efficacy in Turkish mothers undergoing vaginal birth or cesarean birth with different types of anesthesia. Int J Nurs Knowl. 2015 Apr;26(2):73-9. doi: 10.1111/2047-3095.12037. Epub 2014 Jun 5.'}, {'pmid': '30035142', 'type': 'BACKGROUND', 'citation': 'Maharlouei N MD, Pourhaghighi A Medical student, Raeisi Shahraki H PhD, Zohoori D MD, Lankarani KB MD. Factors Affecting Exclusive Breastfeeding, Using Adaptive LASSO Regression. Int J Community Based Nurs Midwifery. 2018 Jul;6(3):260-271.'}]}, 'descriptionModule': {'briefSummary': 'This cross-sectional observational study was conducted to compare breastfeeding success and breastfeeding self-efficacy levels of mothers who gave birth via vaginal delivery (spontaneous or via epidural analgesia) or cesarean section (under general or spinal anesthesia).', 'detailedDescription': 'This study was conducted by including women, who gave birth via VD or CS in the gynecology clinics of a training and research hospital and a city hospital and were in the postpartum period (after 24 hours).\n\nIt compared the breastfeeding self-efficacy and breastfeeding success of mothers who gave birth via CS (under spinal anesthesia or general anesthesia) with those of mothers who gave birth via vaginal delivery (under epidural analgesia or via spontaneous vaginal delivery).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Being aged \\>18 years old women who gave birth via VD or CS in the gynecology clinics of a training and research hospital and a city hospital and were in the early postpartum period (after 24 hours)', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. being aged \\>18 years old;\n2. being literate;\n3. having a baby of weight between 2500-4000 g, with 5th minute APGAR score of ≥7, and without congenital diseases and sucking and swallowing problems;\n4. not having a disease that prevents breastfeeding;\n5. having a full-term (37-42 weeks) VD or CS,\n6. agreeing to participate in the study\n\nExclusion Criteria:\n\n1. a history of psychological or mental health problems\n2. any condition in the mother or infant that was a barrier to breastfeeding\n3. baby's admission into the neonatal unit\n4. baby's separation from the mother for any reason"}, 'identificationModule': {'nctId': 'NCT05106634', 'briefTitle': 'Evaluation of Breastfeeding Success and Self-Efficacy in Mothers Giving Birth Via Vaginal Delivery or Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'Evaluation of Breastfeeding Success and Self-Efficacy Using LATCH in Mothers Giving Birth Via Vaginal Delivery or Cesarean Section: Cross-sectional Study', 'orgStudyIdInfo': {'id': '2019-14/18'}}, 'contactsLocationsModule': {'locations': [{'zip': '16059', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Ul', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'overallOfficials': [{'name': 'Gonca Buran, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uludag Üniversity'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aydin Adnan Menderes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN, PhD, lecturer', 'investigatorFullName': 'Gonca Buran', 'investigatorAffiliation': 'Uludag University'}}}}