Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT07098702
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-01
First Post:
2025-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Ergonomic Practices on Quality of Breastfeeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2025-07-08', 'studyFirstSubmitQcDate': '2025-07-29', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A LATCH score', 'timeFrame': 'At two weeks and two, four and six months after delivery', 'description': 'A LATCH score of 0 to 3 is regarded as poor quality of breastfeeding, 4 to 7 is considered as moderate quality of breastfeeding, and 8 to 10 is considered as good quality of breastfeeding.'}], 'secondaryOutcomes': [{'measure': 'Change in the growth chart of the infants', 'timeFrame': 'At two weeks and two, four, and six months after delivery', 'description': 'neonates of the intervention group will exhibit better growth than neonates of the control group'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ergonomic Practices, Latch, Primiparous, Quality of Breastfeeding, Weight'], 'conditions': ['we Search for the Effect of Ergonomic Practices on Quality of Breastfeeding']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.7860/JCDR/2022/56968.16685', 'label': 'Efficacy of Counselling in Improving LATCH Score and Successful Breastfeeding: A Hospital-based Prospective Cohort Study.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the effectiveness of ergonomic practices on quality of breastfeeding among primiparous.', 'detailedDescription': "Prolonged discomfort experienced during lactation can significantly impede a mother's adjustment to the maternal role. This discomfort arises from suboptimal body positioning and extended periods of sitting during breastfeeding and some mothers stop breastfeeding as a result of that. Consequently, the promotion of maternal comfort during breastfeeding will enhance the quality of breastfeeding, and this will be achieved by encouraging mothers to assume appropriate body mechanics, appropriate breastfeeding positions, and use breastfeeding pillows during breastfeeding. Therefore, the researcher will conduct the current study."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female pregnant mothers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) Nulliparous women, 2) Mothers between the ages of 18 and 35, 3) Mothers who are in the third trimester, 4) Singleton pregnancy, 5) Mothers who have the intention of breastfeeding, and 6) Mothers who can read and write.\n\nExclusion Criteria:\n\n* 1\\) Mothers with nipple problems, such as flat or inverted nipples, and 2) Mothers with medical or surgical problems interfering with breastfeeding.'}, 'identificationModule': {'nctId': 'NCT07098702', 'briefTitle': 'Effect of Ergonomic Practices on Quality of Breastfeeding', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Effectiveness of Ergonomic Practices on Quality of Breastfeeding Among Primiparous', 'orgStudyIdInfo': {'id': 'effect of EP on QOB among pp'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'In this group, the mothers will receive educational sessions regarding appropriate ergonomic practices during breastfeeding which include appropriate body mechanics, breastfeeding positions and breastfeeding pillows', 'interventionNames': ['Other: educational sessions and booklet']}, {'type': 'EXPERIMENTAL', 'label': 'control group', 'interventionNames': ['Other: No Interventions']}], 'interventions': [{'name': 'educational sessions and booklet', 'type': 'OTHER', 'description': 'educational sessions and booklet about ergonomic practices during breastfeeding which include appropriate body mechanics , breastfeeding positions, and use of breastfeeding pillows.', 'armGroupLabels': ['intervention group']}, {'name': 'No Interventions', 'type': 'OTHER', 'description': 'In this group, the mothers will breastfeed their newborns according to the routine hospital postpartum instructions only.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aida Mohamed Ali Abd-Ellatif Omar, Master student', 'role': 'CONTACT', 'email': 'aidamoh@std.mans.edu.eg', 'phone': '+20 01012751401'}, {'name': 'Enas Sabry Fathy Elbeltagy, Lecturer', 'role': 'CONTACT', 'email': 'enassabry25@mans.edu.eg', 'phone': '+20 01067364685'}], 'overallOfficials': [{'name': 'Hanan El-Sayed Mohamed El-Sayed, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Nursing, Mansoura University, Egypt'}, {'name': 'Reda Abd El-Hady Ali Hemeda, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Mansoura University, Egypt'}, {'name': 'Enas Sabry Fathy Elbeltagy, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Nursing, Mansoura University, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Instructor at Technical Institute of Nursing, Faculty of Nursing, Mansoura University', 'investigatorFullName': 'Aida Mohamed Ali Abd-Ellatif', 'investigatorAffiliation': 'Mansoura University'}}}}