Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-28 @ 12:24 PM
Study NCT ID:
NCT06648161
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2024-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Using a Mirror in the Second Stage of Labor: Effects on Duration and Birth Experience
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'resmiyeozdilek@gmail.com', 'phone': '+90 262 303 47 38', 'title': 'Dr. Resmiye Özdilek', 'organization': 'Kocaeli University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From the onset of the second stage of labor until delivery completion and during the first 24 hours postpartum.', 'description': 'No adverse or serious adverse events were observed or reported during the study. Adverse events were monitored during the second stage Participants were monitored for any adverse or serious adverse events during the second stage of labor, delivery, and the first 24 hours postpartum. Standard obstetric observation protocols were followed. No free-text repetition of numerical results is provided; all event counts are presented in the data tables.', 'eventGroups': [{'id': 'EG000', 'title': 'Experiment', 'description': 'In the second stage of labor, the birth mirror will be used to allow the mother to see her own perineum.\n\nLabor Mirror: The labor mirror used in the second stage of labor allows the mother and midwife to observe the descent and birth of the baby during vaginal delivery and provides instant visualization of progress for the mother and midwife, especially in water births or water births', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 0, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'During the birth process, she will receive routine midwifery care and no intervention will be made.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 0, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Childbirth Experience Questionnaire (CEQ) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experiment', 'description': 'In the second stage of labor, the birth mirror will be used to allow the mother to see her own perineum.\n\nLabor Mirror: The labor mirror used in the second stage of labor allows the mother and midwife to observe the descent and birth of the baby during vaginal delivery and provides instant visualization of progress for the mother and midwife, especially in water births or water births'}, {'id': 'OG001', 'title': 'Control', 'description': 'During the birth process, she will receive routine midwifery care and no intervention will be made.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.85', 'spread': '9.76', 'groupId': 'OG000'}, {'value': '70.22', 'spread': '9.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 24 hours postpartum', 'description': "The Childbirth Experience Questionnaire (CEQ) is a validated scale measuring women's birth experiences. It has 22 items across 4 subscales. Total score is the sum of all items converted to a 1-4 scale, yielding a range of 22-88. Higher scores indicate a more positive childbirth experience.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis included women who completed the Childbirth Experience Questionnaire within 24 hours after delivery. Participants who withdrew or had incomplete data were excluded.'}, {'type': 'SECONDARY', 'title': 'Duration of the Second Stage of Labor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experiment', 'description': 'In the second stage of labor, the birth mirror will be used to allow the mother to see her own perineum.\n\nLabor Mirror: The labor mirror used in the second stage of labor allows the mother and midwife to observe the descent and birth of the baby during vaginal delivery and provides instant visualization of progress for the mother and midwife, especially in water births or water births'}, {'id': 'OG001', 'title': 'Control', 'description': 'During the birth process, she will receive routine midwifery care and no intervention will be made.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.52', 'spread': '4.53', 'groupId': 'OG000'}, {'value': '19.48', 'spread': '5.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the second stage of labor, within the birth process', 'description': 'The duration of the second stage of labor was compared between the experimental and control groups to assess the impact of labor mirror use.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the second stage of labor with recorded time data were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experiment', 'description': 'In the second stage of labor, the birth mirror will be used to allow the mother to see her own perineum.\n\nLabor Mirror: The labor mirror used in the second stage of labor allows the mother and midwife to observe the descent and birth of the baby during vaginal delivery and provides instant visualization of progress for the mother and midwife, especially in water births or water births'}, {'id': 'FG001', 'title': 'Control', 'description': 'During the birth process, she will receive routine midwifery care and no intervention will be made.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experiment', 'description': 'In the second stage of labor, the birth mirror will be used to allow the mother to see her own perineum.\n\nLabor Mirror: The labor mirror used in the second stage of labor allows the mother and midwife to observe the descent and birth of the baby during vaginal delivery and provides instant visualization of progress for the mother and midwife, especially in water births or water births'}, {'id': 'BG001', 'title': 'Control', 'description': 'During the birth process, she will receive routine midwifery care and no intervention will be made.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.82', 'spread': '5.35', 'groupId': 'BG000'}, {'value': '25.92', 'spread': '5.02', 'groupId': 'BG001'}, {'value': '26.37', 'spread': '5.18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Turkey', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational Week at Admission', 'classes': [{'categories': [{'measurements': [{'value': '39.21', 'spread': '1.20', 'groupId': 'BG000'}, {'value': '39.33', 'spread': '1.21', 'groupId': 'BG001'}, {'value': '39.27', 'spread': '1.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Mean gestational week at admission was calculated for each study group prior to intervention. This measure indicates the pregnancy week based on the last menstrual period and/or ultrasound assessment at the time of hospital admission for labor. Units are expressed in completed weeks.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-01-14', 'size': 195799, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-14T05:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2024-10-14', 'resultsFirstSubmitDate': '2025-07-14', 'studyFirstSubmitQcDate': '2024-10-16', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-15', 'studyFirstPostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Childbirth Experience Questionnaire (CEQ) Total Score', 'timeFrame': 'Within 24 hours postpartum', 'description': "The Childbirth Experience Questionnaire (CEQ) is a validated scale measuring women's birth experiences. It has 22 items across 4 subscales. Total score is the sum of all items converted to a 1-4 scale, yielding a range of 22-88. Higher scores indicate a more positive childbirth experience."}], 'secondaryOutcomes': [{'measure': 'Duration of the Second Stage of Labor', 'timeFrame': 'During the second stage of labor, within the birth process', 'description': 'The duration of the second stage of labor was compared between the experimental and control groups to assess the impact of labor mirror use.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Labor Stage, Second']}, 'descriptionModule': {'briefSummary': "This study aims to investigate the impact of using a labor mirror during the second stage of labor on both the duration of labor and the mother's overall experience. The main questions it aims to answer are:\n\n* Does using a labor mirror in the second stage of labor affect the duration of labor?\n* Does the use of a labor mirror in the second stage of labor affect women's total birth experience scale score? To assess the effect of using a birth mirror during the second stage of labor on the duration of labor and mothers' satisfaction with labor, the researchers will give one group a birth mirror and the other group will receive normal midwifery care.\n* In the second stage of labor, the birth mirror will be positioned so that the woman can see the progress of the baby as she pushes (lithotomy position).\n* Within 24 hours after delivery, mothers will complete the Birth Experience Scale and an opinion form about the use of the mirror.\n* The control group will not receive any intervention.", 'detailedDescription': "Childbirth is one of the most significant experiences in a woman's life. The second stage of labor, when the cervix is fully dilated and the baby moves through the birth canal, is a crucial phase. Various techniques and tools are used during this stage to assist delivery, one of which is the labor mirror. This tool allows the mother to visually observe the perineum and monitor the progress of labor, especially in water births. Both handheld and bed-mounted options are available, usually made of acrylic, and they can have adjustable angles for better visualization.\n\nThe use of a labor mirror offers several benefits. It enables real-time monitoring of the birthing process, allowing midwives to make timely interventions. More importantly, it helps mothers feel more involved in the birth, boosting their confidence and motivation, especially when they see the baby's head. This can lead to more controlled pushing and potentially shorten the duration of labor.\n\nIn summary, the labor mirror can enhance the birth experience by allowing mothers to participate actively and by providing emotional support, which may reduce the length of the second stage of labor. However, its use is not widespread in Turkey. This study aims to investigate the impact of using a labor mirror during the second stage of labor on both the duration of labor and the mother's overall experience."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between 38-42 weeks of gestation,\n* had a healthy fetus,\n* had no perinatal and obstetric risk,\n* did not have prolonged trauma,\n* could understand and speak Turkish\n\nExclusion Criteria:\n\n* preterm labor onset,\n* premature rupture of membranes,\n* epidural analgesia,\n* amniotic fluid with meconium,\n* fetal risk\n* intervention delivery'}, 'identificationModule': {'nctId': 'NCT06648161', 'briefTitle': 'Using a Mirror in the Second Stage of Labor: Effects on Duration and Birth Experience', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Impact of Using a Mirror in the Second Stage of Labor on Childbirth Duration and Experience', 'orgStudyIdInfo': {'id': 'Suzi-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experiment', 'description': 'In the second stage of labor, the birth mirror will be used to allow the mother to see her own perineum.', 'interventionNames': ['Other: Labor Mirror']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'During the birth process, she will receive routine midwifery care and no intervention will be made.'}], 'interventions': [{'name': 'Labor Mirror', 'type': 'OTHER', 'description': 'The labor mirror used in the second stage of labor allows the mother and midwife to observe the descent and birth of the baby during vaginal delivery and provides instant visualization of progress for the mother and midwife, especially in water births or water births', 'armGroupLabels': ['Experiment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41001', 'city': 'Kocaeli', 'state': 'İzmit', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Resmiye Ozdilek', 'investigatorAffiliation': 'Kocaeli University'}}}}