Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-01-02 @ 2:15 AM
Study NCT ID:
NCT06832332
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-18
First Post:
2025-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alternative Birth Positions During the Second Stage
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': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2025-02-12', 'studyFirstSubmitQcDate': '2025-02-12', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Childbirth Skills Self-Efficacy Scale', 'timeFrame': '1 HOUR'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Simulation']}, 'descriptionModule': {'briefSummary': "Simulation training provided before clinical practice at many universities helps students feel confident and well prepared for the clinical environment. Simulation-based learning not only improves professional competence in midwifery educators but also equips and empowers midwifery students in practice. In undergraduate midwifery education, students are provided obstetric skills training on electronic fetal monitoring (EFM), delivery management, shoulder dystocia, postpartum hemorrhage, breech delivery, umbilical cord prolapse and perineal repair (incision and episiotomy). It has been determined that simulation-based training positively affects the perceived readiness of the participants. It is emphasized that health personnel should be encouraged to freely choose birth positions and be informed about the risks and benefits of upright and supine positions. This study will be conducted to evaluate the effect of midwifery students' use of alternative birth positions in the second stage of labor on students' anxiety, self-efficacy, skill and knowledge levels."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Continuing their third year in the 2024-2025 Spring semester,\n* Students who have passed the normal birth management course\n\nExclusion Criteria:\n\n* Students who fail the normal birth management course'}, 'identificationModule': {'nctId': 'NCT06832332', 'briefTitle': 'Alternative Birth Positions During the Second Stage', 'organization': {'class': 'OTHER', 'fullName': 'Burdur Mehmet Akif Ersoy University'}, 'officialTitle': "Midwifery Students' Experiences and Opinions on Alternative Birthing Positions in the Second Stage of Labor", 'orgStudyIdInfo': {'id': 'MAKÜ Unive'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'INTERVENTION 1', 'interventionNames': ['Behavioral: alternative birthing positions']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Behavioral: alternative birthing positions']}], 'interventions': [{'name': 'alternative birthing positions', 'type': 'BEHAVIORAL', 'description': 'In this stage, students will be given a simulated breech birth with alternative birth positions as opposed to the traditional position in the second stage of labor.', 'armGroupLabels': ['Control Group', 'INTERVENTION 1']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Burdur Mehmet Akif Ersoy University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RESPONSIBLE RESEARCHER_ PhD midwife', 'investigatorFullName': 'Mine Gokduman Keles', 'investigatorAffiliation': 'Burdur Mehmet Akif Ersoy University'}}}}