Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:46 AM
Study NCT ID:
NCT07430020
Status:
COMPLETED
Last Update Posted:
2026-02-24
First Post:
2026-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shared Decision-Making Counseling and Breastfeeding Performance Among Primiparous Women in Iran
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were assigned to two parallel groups. The intervention group received shared decision-making counseling regarding breastfeeding during pregnancy, while the control group received routine prenatal care. Outcomes were compared between the two groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-15', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breastfeeding Performance Index (BPI) score', 'timeFrame': '3 days postpartum and 60 days postpartum', 'description': 'Breastfeeding performance will be assessed using the Breastfeeding Performance Index (BPI). The total score ranges from 0 to 7, with higher scores indicating better breastfeeding performance and greater adherence to exclusive breastfeeding practices.'}], 'secondaryOutcomes': [{'measure': 'Decisional Conflict Scale (DCS) score', 'timeFrame': "Baseline (35-37 weeks' gestation), immediately after the counselling session (same day), and 3 days postpartum", 'description': 'Decisional conflict will be measured using the Decisional Conflict Scale (DCS). The total score ranges from 0 to 100, with higher scores indicating greater decisional conflict.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Shared decision-making', 'Primiparous women', 'Prenatal counseling', 'Breastfeeding performance'], 'conditions': ['Breastfeeding Outcomes', 'Decisional Conflict']}, 'descriptionModule': {'briefSummary': "This quasi-experimental embedded mixed-methods study evaluated the effect of a prenatal shared decision-making (SDM) counseling session on decisional conflict and breastfeeding performance among primiparous women in Zahedan, Iran. A total of 112 pregnant women at 35-37 weeks' gestation were allocated to either an intervention group receiving one 90-minute SDM counseling session or a control group receiving routine prenatal care. Decisional conflict was assessed at baseline, one week post-intervention, and three days postpartum. Breastfeeding performance was evaluated on days 3 and 60 postpartum.", 'detailedDescription': 'This interventional quasi-experimental study with an embedded qualitative component was conducted among primiparous pregnant women in Zahedan, Iran. The quantitative phase included 112 participants recruited at 35-37 weeks of gestation and assigned to either a shared decision-making (SDM) counseling group or a routine care control group.\n\nThe intervention consisted of a single 90-minute individualized prenatal SDM counseling session conducted according to the three-step SDM model (choice talk, option talk, and decision talk). The session addressed infant feeding options, benefits and risks of exclusive breastfeeding, clarification of maternal values and preferences, and available support systems.\n\nThe primary outcome was decisional conflict measured using the 16-item Decisional Conflict Scale (score range 0-100). Secondary outcomes included breastfeeding performance measured using the 7-item Breastfeeding Performance Index at 3 and 60 days postpartum.\n\nAn embedded qualitative grounded theory component explored sociocultural and personal processes influencing infant feeding decisions among participants.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:-Irani\n\n* Primiparous pregnant women\n* Gestational age between 35 and 37 weeks at enrollment\n* Singleton pregnancy\n* First breastfeeding experience\n* Planned delivery in Zahedan hospitals\n* Maternal age between 15 and 40 years\n* Receiving care at comprehensive health centers in Zahedan, Iran\n* Willingness to participate and provide informed consent\n\nExclusion Criteria:\n\n* Contraindications to breastfeeding (e.g., chemotherapy, ergotamines, breast lesions, HIV infection, prenatal depression)\n* Preterm birth (\\<37 weeks)\n* Neonatal intensive care unit (NICU) admission\n* Absence from counseling sessions\n* Congenital anomalies in the infant (e.g., cleft lip or palate)\n* Maternal intensive care unit (ICU) admission\n* High-risk pregnancy (e.g., pre-eclampsia/eclampsia, insulin-dependent diabetes, cardiac disease)'}, 'identificationModule': {'nctId': 'NCT07430020', 'acronym': 'SDM', 'briefTitle': 'Shared Decision-Making Counseling and Breastfeeding Performance Among Primiparous Women in Iran', 'organization': {'class': 'OTHER', 'fullName': 'Zahedan University of Medical Sciences'}, 'officialTitle': 'Effect of Prenatal Shared Decision-Making Counseling on Decisional Conflict and Breastfeeding Performance Among Primiparous Women: A Quasi-Experimental Embedded Mixed-Methods Study', 'orgStudyIdInfo': {'id': 'SDM-BF-2024-ZAUMS'}, 'secondaryIdInfos': [{'id': 'IR.ZAUMS.REC.1403.405', 'type': 'OTHER', 'domain': 'Zahedan University of Medical Sciences'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Routine Prenatal Care', 'description': 'Pregnant women received routine prenatal care without shared decision-making counseling.', 'interventionNames': ['Behavioral: Shared Decision-Making Counseling']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Shared Decision-Making Counseling', 'description': 'Pregnant women received shared decision-making counseling sessions regarding breastfeeding during prenatal care.', 'interventionNames': ['Behavioral: Shared Decision-Making Counseling']}], 'interventions': [{'name': 'Shared Decision-Making Counseling', 'type': 'BEHAVIORAL', 'description': 'Pregnant women received shared decision-making counseling sessions regarding breastfeeding during prenatal care.', 'armGroupLabels': ['Experimental: Shared Decision-Making Counseling', 'Routine Prenatal Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9816675595', 'city': 'Zahedan', 'state': 'Sistan and Baluchestan', 'country': 'Iran', 'facility': 'conducted at comprehensive health centers in Zahedan', 'geoPoint': {'lat': 29.4963, 'lon': 60.8629}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) collected during the study will not be shared. The data contain confidential health information and were collected under ethical approval that does not permit public data sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zahedan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Reproductive Health', 'investigatorFullName': 'Zahra Moudi', 'investigatorAffiliation': 'Zahedan University of Medical Sciences'}}}}