Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT05863156
Status:
COMPLETED
Last Update Posted:
2025-03-03
First Post:
2023-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of the Effects of Different Positions Given During Antenatal Electro-Fetal Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tugba.yilmazesencan@uskudar.edu.tr', 'phone': '05057084946', 'title': 'Tugba YILMAZ ESENCAN', 'organization': 'Uskudar Univercity'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'In the limited number of similar studies in the literature, it has been the supine position that has been examined but this has not produced robust results. For this reason, differing from other studies, the present study sought to examine the effects of the right lateral position and BMI on maternal blood pressure and fetal health.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'There was no risk for any pregnant woman in the study.There is no risk for pregnant women participating in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention 1', 'description': 'electro fetal monitoring\n\nRight side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)\n\nSemi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)\n\nleft side lying position: In the study, 120 participants in the left side lying position (control group).', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention 2', 'description': 'electro fetal monitoring\n\nRight side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)\n\nSemi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)\n\nleft side lying position: In the study, 120 participants in the left side lying position (control group).', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control Group', 'description': 'electro fetal monitoring\n\nRight side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)\n\nSemi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)\n\nleft side lying position: In the study, 120 participants in the left side lying position (control group).', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 0, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Right Side Lying Post NST (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention 1', 'description': 'electro fetal monitoring\n\nRight side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)\n\nSemi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)\n\nleft side lying position: In the study, 120 participants in the left side lying position (control group).'}, {'id': 'OG001', 'title': 'Intervention 2', 'description': 'electro fetal monitoring\n\nRight side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)\n\nSemi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)\n\nleft side lying position: In the study, 120 participants in the left side lying position (control group).'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'electro fetal monitoring\n\nRight side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)\n\nSemi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)\n\nleft side lying position: In the study, 120 participants in the left side lying position (control group).'}], 'classes': [{'categories': [{'measurements': [{'value': '113.67', 'spread': '10.06', 'groupId': 'OG000'}, {'value': '108.16', 'spread': '10.56', 'groupId': 'OG001'}, {'value': '112.80', 'spread': '11.21', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'before NST', 'description': 'Blood Pressure (Systolic)-Blood pressure measurements were made before, during and after fetal monitoring of the pregnant women.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Right Side Lying', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention 1', 'description': 'electro fetal monitoring\n\nRight side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)\n\nSemi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)\n\nleft side lying position: In the study, 120 participants in the left side lying position (control group).'}, {'id': 'OG001', 'title': 'Intervention 2', 'description': 'electro fetal monitoring\n\nRight side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)\n\nSemi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)\n\nleft side lying position: In the study, 120 participants in the left side lying position (control group).'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'electro fetal monitoring\n\nRight side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)\n\nSemi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)\n\nleft side lying position: In the study, 120 participants in the left side lying position (control group).'}], 'classes': [{'categories': [{'measurements': [{'value': '110.37', 'spread': '9.41', 'groupId': 'OG000'}, {'value': '107.00', 'spread': '8.57', 'groupId': 'OG001'}, {'value': '108.89', 'spread': '11.00', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'NST instant', 'description': 'Blood Pressure (Systolic)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Right Side Lying', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention 1', 'description': 'electro fetal monitoring\n\nRight side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)\n\nSemi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)\n\nleft side lying position: In the study, 120 participants in the left side lying position (control group).'}, {'id': 'OG001', 'title': 'Intervention 2', 'description': 'electro fetal monitoring\n\nRight side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)\n\nSemi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)\n\nleft side lying position: In the study, 120 participants in the left side lying position (control group).'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'electro fetal monitoring\n\nRight side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)\n\nSemi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)\n\nleft side lying position: In the study, 120 participants in the left side lying position (control group).'}], 'classes': [{'categories': [{'measurements': [{'value': '115.91', 'spread': '10.76', 'groupId': 'OG000'}, {'value': '100.08', 'spread': '8.15', 'groupId': 'OG001'}, {'value': '113.56', 'spread': '12.28', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'post NST (NST time:1 minute)', 'description': 'Blood Pressure (Systolic)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'The Right Lateral Position', 'description': 'electro fetal monitoring\n\nRight side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)\n\nSemi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)\n\nleft side lying position: In the study, 120 participants in the left side lying position (control group).'}, {'id': 'FG001', 'title': 'The Semi-Fowler Position', 'description': 'electro fetal monitoring\n\nRight side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)\n\nSemi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)\n\nleft side lying position: In the study, 120 participants in the left side lying position (control group).'}, {'id': 'FG002', 'title': 'Control Group: the Left Lateral Position', 'description': 'electro fetal monitoring\n\nRight side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)\n\nSemi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)\n\nleft side lying position: In the study, 120 participants in the left side lying position (control group).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'The intervention group, which was fixed at 120 pregnant woman, was divided into two subgroups in which 60 women were placed in the right lateral side-lying position (Intervention 1)\n\nAllocated to intervention (n=81):\n\nReceived allocated intervention (n=60) It was excluded because of insufficient follow-up time with NST (n=21)', 'groupId': 'FG000', 'numSubjects': '81'}, {'comment': 'the second group of 60 women was placed in the semi-Fowler position (Intervention 2)\n\nAllocated to intervention (n=81):\n\nReceived allocated intervention (n=60) It was excluded because of insufficient follow-up time with NST (n=21)', 'groupId': 'FG001', 'numSubjects': '81'}, {'comment': 'Since the women in this group were placed in the left lateral position that is routinely applied in the clinic in which the study was conducted, this was considered the control group.\n\nAllocated to intervention (n=143):Received allocated intervention (n=120) It was excluded because of insufficient follow-up time with NST (n=23)', 'groupId': 'FG002', 'numSubjects': '143'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completion of electro monitoring application in the appropriate position', 'groupId': 'FG000', 'numSubjects': '60'}, {'comment': 'Completion of electro monitoring application in the appropriate position', 'groupId': 'FG001', 'numSubjects': '60'}, {'comment': 'Completion of electro monitoring application in the appropriate position', 'groupId': 'FG002', 'numSubjects': '120'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Failure to complete the electro-monitoring application in the appropriate position', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '23'}]}]}], 'recruitmentDetails': 'December 2021 - January 2023', 'preAssignmentDetails': 'Randomization for the study was carried out on the website random.org; unique values were generated to divide 305 into 2 unique groups. The first group of 161 (81+81) numbers was randomly assigned to the intervention group, while the second group of 143 numbers was assigned to the control group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '240', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Right Lateral Side-Lying Position', 'description': 'electro fetal monitoring\n\nRight side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)\n\nSemi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)\n\nleft side lying position: In the study, 120 participants in the left side lying position (control group).'}, {'id': 'BG001', 'title': 'Semi-Fowler Position', 'description': 'electro fetal monitoring\n\nRight side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)\n\nSemi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)\n\nleft side lying position: In the study, 120 participants in the left side lying position (control group).'}, {'id': 'BG002', 'title': 'Left Lateral Side-Lying Position', 'description': 'electro fetal monitoring\n\nRight side lying position: In the study, 60 participants were placed in the right side lying position (intervention 1)\n\nSemi Fowler: In the study, 60 participants in the semi-sitting position (intervention 2)\n\nleft side lying position: In the study, 120 participants in the left side lying position (control group).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': 'Age', 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '238', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.62', 'spread': '4.43', 'groupId': 'BG000'}, {'value': '29.57', 'spread': '3.93', 'groupId': 'BG001'}, {'value': '30.24', 'spread': '4.64', 'groupId': 'BG002'}, {'value': '31.62', 'spread': '4.46', 'groupId': 'BG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '240', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '240', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Turkey', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '240', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'title': '30 and over (obese)', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}, {'title': '25-29 (overweight)', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}, {'title': '19-24 (normal)', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}, {'title': '18 and below (underweight)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Body mass indexes of pregnant women were calculated.', 'unitOfMeasure': 'Participants'}], 'populationDescription': "The intervention group, comprising 120 pregnant women, was further divided into two subgroups: 60 women were assigned to the right lateral position, and 60 women to the semi-Fowler position. The control group, also consisting of 120 women, adhered to the clinic's routine practice of the left lateral position. All women in this group were placed in the left lateral position, with the remainder of the procedure conducted in the same manner as for the intervention groups."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-18', 'size': 154821, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-09-15T15:59', 'hasProtocol': True}, {'date': '2019-12-18', 'size': 367274, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-15T15:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study was conducted in a pregnant follow-up outpatient clinic of a maternity hospital in Istanbul, between December 2021 and January 2023, in a randomized controlled experimental study design with two interventions and a control group. In the study, 60 participants were placed in the right side lying position (intervention 1), 60 participants in the semi-sitting position (intervention 2) and 120 participants in the left side lying position (control group), and the study was completed with a total of 240 pregnant women. Research data were collected through the Information Form and the General Comfort Scale-Short Form.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 305}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2023-03-28', 'resultsFirstSubmitDate': '2023-05-28', 'studyFirstSubmitQcDate': '2023-05-08', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-07', 'studyFirstPostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Right Side Lying', 'timeFrame': 'post NST (NST time:1 minute)', 'description': 'Blood Pressure (Systolic)'}], 'primaryOutcomes': [{'measure': 'Right Side Lying Post NST (3)', 'timeFrame': 'before NST', 'description': 'Blood Pressure (Systolic)-Blood pressure measurements were made before, during and after fetal monitoring of the pregnant women.'}], 'secondaryOutcomes': [{'measure': 'Right Side Lying', 'timeFrame': 'NST instant', 'description': 'Blood Pressure (Systolic)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fetal Monitoring', 'Patient Comfort', 'Maternal Health', 'Midwifery'], 'conditions': ['Fetal Monitoring', 'Patient Comfort', 'Maternal Health']}, 'referencesModule': {'references': [{'pmid': '29772936', 'type': 'BACKGROUND', 'citation': 'Humphries A, Mirjalili SA, Tarr GP, Thompson JMD, Stone P. The effect of supine positioning on maternal hemodynamics during late pregnancy. J Matern Fetal Neonatal Med. 2019 Dec;32(23):3923-3930. doi: 10.1080/14767058.2018.1478958. Epub 2018 Jun 3.'}, {'pmid': '39773730', 'type': 'DERIVED', 'citation': 'Yilmaz Esencan T, Demir Yildirim A, Sagiroglu E. Effects of maternal positions in electronic fetal monitoring: a randomised controlled trial. BMC Nurs. 2025 Jan 7;24(1):22. doi: 10.1186/s12912-024-02654-w.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to assess the effects of different maternal positions during electronic fetal monitoring (EFM) on maternal and fetal health outcomes. The study was conducted between December 2021 and January 2023 in a maternity hospital in Istanbul, employing a randomized controlled trial design. A total of 240 pregnant women were randomized into three groups: 60 participants were assigned to the right-side lying position (intervention 1), 60 to the semi-sitting position (intervention 2), and 120 to the left-side lying.\n\nMaternal systolic blood pressure, body temperature, and pulse rate were measured before, during, and after the EFM procedure. Research data were collected through the Information Form and the General Comfort Scale-Short Form.', 'detailedDescription': 'IIntroduction: Electronic fetal monitoring (EFM) is widely utilized for pregnancy and labor management due to its non-invasive nature, ease of use, and accessibility. However, the accuracy of EFM outcomes may be influenced by various factors, including the maternal position during monitoring, maternal comfort, and maternal blood pressure. This study aimed to explore how different positions during EFM influence both maternal.\n\nObjective: The primary objective of this study was to examine the effects of three different maternal positions during EFM-right-side lying, semi-sitting, and left-side lying-on maternal and fetal health parameters. These parameters included systolic blood pressure, body temperature, pulse rate, and maternal comfort.\n\nMethods:\n\nA randomized controlled trial was conducted in a pregnancy follow-up outpatient clinic at a maternity hospital in Istanbul from December 2021 to January 2023. The study included 240 pregnant women, who were randomly assigned to one of three groups:\n\n* Intervention 1 (right-side lying position) - 60 participants\n* Intervention 2 (semi-sitting position) - 60 participants\n* Control group (left-side lying position) - 120 participants Maternal physiological data were collected at three time points: pre-EFM, during EFM, and post-EFM. The General Comfort Scale-Short Form was used to assess maternal comfort. Statistical analyses were conducted to identify significant differences between groups and over time.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being over the age of 18,\n* Being 35 years of age and under,\n* Being a single fetus in the late 3rd trimester (34th-40th gestational week),\n* Fetal biometric measurements between 34-40 weeks of gestation,\n* No maternal and fetal risk affecting pregnancy,\n* It was determined that the vital signs were within normal values before the application, not being hungry during the application (at the latest 2 hours of fasting time will be checked), and accepting the recommended application position.\n\nExclusion Criteria:\n\n\\- The pregnant woman does not accept the recommended application position.'}, 'identificationModule': {'nctId': 'NCT05863156', 'briefTitle': 'Evaluation of the Effects of Different Positions Given During Antenatal Electro-Fetal Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'Uskudar University'}, 'officialTitle': 'Evaluation of the Effects of Different Positions Given During Antenatal Electro-Fetal Monitoring on Maternal Comfort, Maternal Blood Pressure and Fetal Health', 'orgStudyIdInfo': {'id': 'NST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention 1', 'description': 'electro fetal monitoring', 'interventionNames': ['Diagnostic Test: Right side lying position', 'Diagnostic Test: Semi Fowler', 'Diagnostic Test: left side lying position']}, {'type': 'EXPERIMENTAL', 'label': 'intervention 2', 'description': 'electro fetal monitoring', 'interventionNames': ['Diagnostic Test: Right side lying position', 'Diagnostic Test: Semi Fowler', 'Diagnostic Test: left side lying position']}, {'type': 'EXPERIMENTAL', 'label': 'control group', 'description': 'electro fetal monitoring', 'interventionNames': ['Diagnostic Test: Right side lying position', 'Diagnostic Test: Semi Fowler', 'Diagnostic Test: left side lying position']}], 'interventions': [{'name': 'Right side lying position', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['(intervention 1)'], 'description': 'In the study, 60 participants were placed in the right side lying position (intervention 1)', 'armGroupLabels': ['control group', 'intervention 1', 'intervention 2']}, {'name': 'Semi Fowler', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['(intervention 2)'], 'description': 'In the study, 60 participants in the semi-sitting position (intervention 2)', 'armGroupLabels': ['control group', 'intervention 1', 'intervention 2']}, {'name': 'left side lying position', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['(control group)'], 'description': 'In the study, 120 participants in the left side lying position (control group).', 'armGroupLabels': ['control group', 'intervention 1', 'intervention 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'state': 'Ümraniye', 'country': 'Turkey (Türkiye)', 'facility': 'Uskudar Univercity', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'TUĞBA YILMAZ ESENCAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uskudar University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uskudar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice-dean', 'investigatorFullName': 'Tuğba YILMAZ ESENCAN', 'investigatorAffiliation': 'Uskudar University'}}}}