Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-02-22 @ 12:23 PM
Study NCT ID:
NCT04729166
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2021-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Management of Perceived Breastmilk Insufficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061186', 'term': 'Breast Milk Expression'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:1 randomization)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2021-01-16', 'studyFirstSubmitQcDate': '2021-01-26', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The starting breastfeeding in the first hour', 'timeFrame': 'Postpartum 3rd-7th day', 'description': 'assessed using the Breastfeeding Follow-up Form in 3rd-7th day postpartum. Mothers reported whether they started breastfeeding within the first hour after birth.'}, {'measure': 'Bottle-feeding', 'timeFrame': 'Postpartum 3rd-7th day', 'description': 'assessed using the Breastfeeding Follow-up Form in 3rd-7th day postpartum. Mothers reported whether they feed her baby with bottle-feeding.'}, {'measure': "The baby's amount of milk intake", 'timeFrame': 'Postpartum 3rd-7th day', 'description': "assessed using The Scoring System for Measuring a Baby's Intake of Breast Milk. This measurement tool was developed to assess the amount of breast milk a baby is fed. The form is made up of 5 sections: the baby's weight, state of satisfaction, frequency and characteristics of urination and defecation and the condition of the mother's breasts. This tool is filled by observation, measurement and interview. The tool rates each status on the basis of 0, 1 or 2, the highest possible total score being 10. A score of 8-10 indicates that the intake of breast milk is good, 0-7 indicates an insufficient intake."}, {'measure': "The baby's amount of milk intake", 'timeFrame': 'Postpartum the 1st month', 'description': "assessed using The Scoring System for Measuring a Baby's Intake of Breast Milk. This measurement tool was developed to assess the amount of breast milk a baby is fed. The form is made up of 5 sections: the baby's weight, state of satisfaction, frequency and characteristics of urination and defecation and the condition of the mother's breasts. This tool is filled by observation, measurement and interview. The tool rates each status on the basis of 0, 1 or 2, the highest possible total score being 10. A score of 8-10 indicates that the intake of breast milk is good, 0-7 indicates an insufficient intake."}, {'measure': "The baby's amount of milk intake", 'timeFrame': 'Postpartum 2nd month', 'description': "assessed using The Scoring System for Measuring a Baby's Intake of Breast Milk. This measurement tool was developed to assess the amount of breast milk a baby is fed. The form is made up of 5 sections: the baby's weight, state of satisfaction, frequency and characteristics of urination and defecation and the condition of the mother's breasts. This tool is filled by observation, measurement and interview. The tool rates each status on the basis of 0, 1 or 2, the highest possible total score being 10. A score of 8-10 indicates that the intake of breast milk is good, 0-7 indicates an insufficient intake."}, {'measure': "Exclusively feeding with mother's milk", 'timeFrame': 'Postpartum 3rd-7th day', 'description': "assessed using the Breastfeeding Follow-up Form. Mothers reported whether they feed her baby with exclusively mother's milk."}, {'measure': "Exclusively feeding with mother's milk", 'timeFrame': 'Postpartum the 1st month', 'description': "assessed using the Breastfeeding Follow-up Form. Mothers reported whether they feed her baby with exclusively mother's milk."}, {'measure': "Exclusively feeding with mother's milk", 'timeFrame': 'Postpartum 2nd month', 'description': "assessed using the Breastfeeding Follow-up Form. Mothers reported whether they feed her baby with exclusively mother's milk."}, {'measure': 'Believing breast milk is adequate', 'timeFrame': 'Postpartum 3rd-7th day', 'description': 'assessed using the Breastfeeding Follow-up Form. Mothers reported whether they believed her baby take adequate breast milk.'}, {'measure': 'Believing breast milk is adequate', 'timeFrame': 'Postpartum the 1st month', 'description': 'assessed using the Breastfeeding Follow-up Form. Mothers reported whether they believed her baby take adequate breast milk.'}, {'measure': 'Believing breast milk is adequate', 'timeFrame': 'Postpartum 2nd month', 'description': 'assessed using the Breastfeeding Follow-up Form. Mothers reported whether they believed her baby take adequate breast milk.'}], 'secondaryOutcomes': [{'measure': "Baby's height", 'timeFrame': 'Postpartum 3rd-7th day', 'description': "used to determine the baby's height. Baby's height was measured and recorded by the researcher to The Breastfeeding Follow-up Form as cm."}, {'measure': "Baby's height", 'timeFrame': 'Postpartum 1st month', 'description': "used to determine the baby's height. Baby's height was measured and recorded by the researcher to The Breastfeeding Follow-up Form as cm."}, {'measure': "Baby's height", 'timeFrame': 'Postpartum 2nd month', 'description': "used to determine the baby's height. Baby's height was measured and recorded by the researcher to The Breastfeeding Follow-up Form as cm."}, {'measure': 'Believing the baby is adequately fed.', 'timeFrame': 'Postpartum 3rd-7th day', 'description': 'assessed using the Breastfeeding Follow-up Form. Mothers reported whether they believed her baby fed adequate.'}, {'measure': 'Believing the baby is adequately fed.', 'timeFrame': 'Postpartum 1st month', 'description': 'assessed using the Breastfeeding Follow-up Form. Mothers reported whether they believed her baby fed adequate.'}, {'measure': 'Believing the baby is adequately fed.', 'timeFrame': 'Postpartum 2nd month', 'description': 'assessed using the Breastfeeding Follow-up Form. Mothers reported whether they believed her baby fed adequate.'}, {'measure': "Being satisfied with baby's weight gain.", 'timeFrame': 'Postpartum 3rd-7th day', 'description': "assessed using the Breastfeeding Follow-up Form. Mothers reported whether they were satisfied from her baby's weight gain."}, {'measure': "Being satisfied with baby's weight gain.", 'timeFrame': 'Postpartum 1st month', 'description': "assessed using the Breastfeeding Follow-up Form. Mothers reported whether they were satisfied from her baby's weight gain."}, {'measure': "Being satisfied with baby's weight gain.", 'timeFrame': 'Postpartum 2nd month', 'description': "assessed using the Breastfeeding Follow-up Form. Mothers reported whether they were satisfied from her baby's weight gain."}, {'measure': "Baby's weight", 'timeFrame': 'Postpartum 3rd-7th day', 'description': "used to determine the baby's weight. Baby's weight was measured and recorded by the researcher to The Breastfeeding Follow-up Form as grams."}, {'measure': "Baby's weight", 'timeFrame': 'Postpartum 1st month', 'description': "used to determine the baby's weight. Baby's weight was measured and recorded by the researcher to The Breastfeeding Follow-up Form as grams."}, {'measure': "Baby's weight", 'timeFrame': 'Postpartum 2nd month', 'description': "used to determine the baby's weight. Baby's weight was measured and recorded by the researcher to The Breastfeeding Follow-up Form as grams."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breastmilk', 'breastfeeding', 'education', 'follow-up'], 'conditions': ['Breast Milk Expression', 'Breast Feeding, Exclusive']}, 'descriptionModule': {'briefSummary': 'A randomized control trial was made to determine the effectiveness of structured education and follow-up in the management of perceived milk insufficiency among breastfeeding mothers.', 'detailedDescription': "Mothers 'perception of breastmilk insufficiency are important conditions affecting babies' exclusively breastfeeding in the first six months.\n\nThis study was made to determine the effectiveness of structured education and follow-up in the management of perceived breastmilk insufficiency among breastfeeding mothers. It was tested the hypotheses that there are no differences between mothers who have been provided with structured education and follow-up and those who have not received the education in terms of initiating breastfeeding in the first one hour, breastmilk insufficiency perceptions, the rate of exclusive feeding of breast milk to babies 0-2 months old, the baby's amount of milk intake and weight gain."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women in their 32nd-42nd week of pregnancy\n* Being literate in Turkish\n* Being at least a primary school graduate\n\nExclusion Criteria:\n\n* Having a history of psychological or mental health problems\n* Having any condition in the mother or infant that was a barrier to breastfeeding\n* The baby's admission into the neonatal unit\n* The baby's separation from the mother for any reason"}, 'identificationModule': {'nctId': 'NCT04729166', 'briefTitle': 'The Management of Perceived Breastmilk Insufficiency', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'Effectiveness of Structured Education and Follow-up on Management of Perceived Breastmilk Insufficiency: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'Interventional'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'The study group were provided with education with structured educational material and followed in this study, in addition to the usual care provided by healthcare professionals.', 'interventionNames': ['Behavioral: Structured education and follow-up']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Control group was int the usual care.'}], 'interventions': [{'name': 'Structured education and follow-up', 'type': 'BEHAVIORAL', 'description': 'This structured educational material was developed by the authors on the basis of the literature. Interventions of the study were carried out in the 32nd-42nd week of pregnancy, 3rd-7th day postpartum, and at the 1st month. At first stage, a 15-20-minute education was given to the pregnant women in the study group in the breastfeeding room of the facility, educational booklets were distributed. The main emphasis parts of the education were repeated with a standard summary information form at each follow-up.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09100', 'city': 'Aydin', 'state': 'Efeler', 'country': 'Turkey (Türkiye)', 'facility': 'Aydın Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}], 'overallOfficials': [{'name': 'Zekiye Karaçam, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': '6 months after publication', 'ipdSharing': 'YES', 'description': 'The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.', 'accessCriteria': 'relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aydin Adnan Menderes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zekiye Karaçam', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}