Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT07196202
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laid Back Breastfeeding Position on Breastfeeding Experience
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'One group of mothers (the intervention group) will be trained on the laid-back position. The other group (the control group) will receive standard care. The outcomes for these two distinct groups were then compared. The groups will treated independently and in parallel.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 168}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2025-09-19', 'studyFirstSubmitQcDate': '2025-09-19', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breastfeeding Experience Scale (BES)', 'timeFrame': '1st time for assessment will be within 24 to 48 hrs after giving birth. 2nd time for assessment will be one week after birth.', 'description': 'BES consists of 30 items (18- items to assess presence or absence and severity of common breastfeeding difficulties in the early postpartum period and 12 items to assess breastfeeding continuation and the reasons for weaning). In the current study, the researcher used the 18 item part of BES because it suites the aim of the study. The 18-item part are divided into five categories including 3items for breast concern, 5 items for mechanics of breast concern, 5 items for process concern, 3 items for insufficient milk production and 2 items for social concern.\n\nScoring system The score system for breastfeeding difficulties using three point Likert scale ranged from "never" (1), "sometimes" (2) and "always" (3). The total scores were ranged from 18 to 54. the level of difficulties were categorized as the following: low severity (\\< 60%) were ranged from 0 \\> 32point, average severity (60 % to \\< 80%) were ranged from 32 \\> 43 point and high severity (≥80 %) were ranged from 43≥ 54 point.'}], 'secondaryOutcomes': [{'measure': 'Maternal comfort during breastfeeding (MCRS)', 'timeFrame': 'One week after delivery', 'description': 'MCRS consists of 9 items describes the maternal feelings during breastfeeding including maternal relaxation during feeding, degree of maternal confidence to hold her baby in laid back position during feeding....ect.\n\nScoring system for MCRS The total scores Maternal comfort ranged from 9 to 36 then the level of comfort categorized as; low \\< 60% (9 - 21); moderate 60% to \\<75% (22 - 27) \\& high ≥ 75% (28 - 36).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laid back position', 'breastfeeding experience', 'breastfeeding comfort'], 'conditions': ['Maternal Breastfeeding Experience', 'Maternal Breastfeeding Comfort']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the effect of laid back breast feeding position on breastfeeding experience among multiparous women. The main questions it aims to answer are;\n\n* Do postpartum women who feed their babies in a laid-back position report a better breastfeeding experience than those who use the cradle position?\n* Do postpartum women who feed their babies in a laid-back position report greater breastfeeding comfort than those who use the cradle position? Researchers will compare breastfeeding in laid-back position to cradle position to see if postpartum women who feed their babies in a laid-back position have better breastfeeding experience and comfort\n\nParticipants will:\n\n* Have educational sessions on breastfeeding in laid-back position during antenatal visit of the 3rd trimester\n* Will be followed by the researcher for any clarifications about the educational content of session\n* Will be asked to apply laid-back position after giving birth, so, the researcher evaluate its effect on breastfeeding experience and comfort.', 'detailedDescription': "Cesarean sections are major surgeries that can cause pain and complications, making early breastfeeding initiation less likely compared to vaginal birth. This is problematic because early breastfeeding has significant health benefits for both mother and infant. Breastfeeding outcomes after C-sections are often worse, including delays, more difficulties, and shorter duration.\n\nA common cause of these problems is inadequate breastfeeding technique. The laid-back breastfeeding position is a simple method that relies on the mother's intuition and the baby's natural reflexes, requiring little professional guidance.\n\nThis study used a quasi-experimental research design. It will conducted at the antenatal outpatient clinic and inpatient wards of Mansoura University Hospital. The study involved a total of 168 participants. Pregnant mothers in intervention group will be trained to breastfeed their infants using the laid-back position."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Multiparous women aged 20 -35 years.\n* Multiparous women At the 34 to 36 weeks of gestational age\n* Multiparous women with normal course of pregnancy with single-tone fetus\n* Multiparous women planning to deliver at Mansoura University Hospital\n* Multiparous women who will perform elective caesarian section\n* Multiparous women planning to breast feed their babies\n* Multiparous women who have no information about laid breastfeeding position\n* Multiparous women who will deliver neonate with normal ABGAR score\n* Multiparous women who will deliver neonate weight 2.5: 3.5 kg.\n\nExclusion Criteria:\n\n* Mothers who had inverted or flat nipple.\n* Mothers who have postpartum complications\n* Mothers who delivered babies with cleft lip, cleft palate, preterm, neurological deficit, asphyxia or any abnormal condition will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT07196202', 'acronym': 'LBB/PBE', 'briefTitle': 'Laid Back Breastfeeding Position on Breastfeeding Experience', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Effect of Laid Back Breastfeeding Position on Breastfeeding Experience Among Multiparous Women', 'orgStudyIdInfo': {'id': '0669'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Laid-Back Positioning Group', 'description': 'Multiparous women who receive structured training and support on the laid-back breastfeeding position during the last trimester of pregnancy so, they can apply it after giving birth', 'interventionNames': ['Other: Laid-Back position training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard Care Group', 'description': 'Multiparous women who receive the standard postpartum breastfeeding care and support offered by the hospital after giving birth', 'interventionNames': ['Other: Standard Postpartum Care']}], 'interventions': [{'name': 'Laid-Back position training', 'type': 'OTHER', 'description': 'This intervention is a structured training session for pregnant woman on the use of the laid-back breastfeeding position after birth. The training is designed to be delivered in a single, standardized session by the researcher during the last trimester of pregnancy to be applied within the first 24 hours post-cesarean delivery.', 'armGroupLabels': ['Laid-Back Positioning Group']}, {'name': 'Standard Postpartum Care', 'type': 'OTHER', 'description': 'Postpartum mothers who receive structured training and support on the laid-back breastfeeding position', 'armGroupLabels': ['Standard Care Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35511', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Mansoura University Hospitals', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}, {'zip': '35511', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'New Obstetric and Gynecological Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Nadia Y AbdElla, Assisttant professor', 'role': 'CONTACT', 'email': 'drnadiaabdella@gmail.com', 'phone': '+20-50-2733200'}], 'overallOfficials': [{'name': 'Nadia Y AbdElla, Asistatnt Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Nursing- Mansoura University- Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The reason for not sharing data is to comply with and protect the confidentiality of participants, which is a primary ethical requirement in research.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nadia Youssef Ahmed AbdElla', 'investigatorAffiliation': 'Mansoura University'}}}}