Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
Study NCT ID:
NCT05289869
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2022-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Pilot Study: High Versus Low Oxytocin Dosing for Induction of Labor in Pregnant Patients With Obesity
Sponsor:
Organization:
Raw JSON
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following delivery', 'description': "An adverse event (AE) will be defined as any untoward or unfavorable medical occurrence in a study participant, whether or not considered related to the subject's participation in the research.", 'eventGroups': [{'id': 'EG000', 'title': 'High-dose', 'description': 'Group randomized to high-dose oxytocin regimen', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low-dose', 'description': 'Group randomized to low-dose oxytocin regimen', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hospital readmission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Delivered by Cesarean', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose', 'description': 'Group randomized to high-dose oxytocin regimen'}, {'id': 'OG001', 'title': 'Low-dose', 'description': 'Group randomized to low-dose oxytocin regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Until delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Time From Start of Induction to Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose', 'description': 'Group randomized to high-dose oxytocin regimen'}, {'id': 'OG001', 'title': 'Low-dose', 'description': 'Group randomized to low-dose oxytocin regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000', 'lowerLimit': '15.9', 'upperLimit': '30.3'}, {'value': '24.7', 'groupId': 'OG001', 'lowerLimit': '21.2', 'upperLimit': '34.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of induction to delivery', 'description': 'Time from start of induction with medication or Foley catheter until delivery', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of the First Stage of Labor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose', 'description': 'Group randomized to high-dose oxytocin regimen'}, {'id': 'OG001', 'title': 'Low-dose', 'description': 'Group randomized to low-dose oxytocin regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000', 'lowerLimit': '14.2', 'upperLimit': '28.6'}, {'value': '21.4', 'groupId': 'OG001', 'lowerLimit': '16.3', 'upperLimit': '26.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of induction to delivery', 'description': 'Time from start of labor to complete dilation', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Occurrence of Tachysystole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose', 'description': 'Group randomized to high-dose oxytocin regimen'}, {'id': 'OG001', 'title': 'Low-dose', 'description': 'Group randomized to low-dose oxytocin regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of induction to delivery', 'description': 'Defined as more than 5 contractions in 10 minutes averaged over 30 minutes', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Uterine Rupture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose', 'description': 'Group randomized to high-dose oxytocin regimen'}, {'id': 'OG001', 'title': 'Low-dose', 'description': 'Group randomized to low-dose oxytocin regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of induction to delivery', 'description': 'Defined as a complete disruption of all uterine layers including serosa', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Clinical Chorioamnionitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose', 'description': 'Group randomized to high-dose oxytocin regimen'}, {'id': 'OG001', 'title': 'Low-dose', 'description': 'Group randomized to low-dose oxytocin regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of induction thorough delivery', 'description': 'Defined based on clinical diagnosis as documented by the clinical care team', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Postpartum Maternal Infectious Morbidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose', 'description': 'Group randomized to high-dose oxytocin regimen'}, {'id': 'OG001', 'title': 'Low-dose', 'description': 'Group randomized to low-dose oxytocin regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 6 weeks following delivery', 'description': 'Defined as a composite outcome of endomyometritis, puerperal sepsis, or surgical site infection as documented in the the clinical record', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Maternal Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose', 'description': 'Group randomized to high-dose oxytocin regimen'}, {'id': 'OG001', 'title': 'Low-dose', 'description': 'Group randomized to low-dose oxytocin regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 6 weeks of delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Immediate Postpartum Hemorrhage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose', 'description': 'Group randomized to high-dose oxytocin regimen'}, {'id': 'OG001', 'title': 'Low-dose', 'description': 'Group randomized to low-dose oxytocin regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 24 hours of delivery', 'description': 'Defined as \\>1000 mL of blood loss within 24 hours of delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Maternal Blood Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose', 'description': 'Group randomized to high-dose oxytocin regimen'}, {'id': 'OG001', 'title': 'Low-dose', 'description': 'Group randomized to low-dose oxytocin regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization through hospital discharge up to 6 weeks portpartum', 'description': 'Defined as need for blood transfusion', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Maternal ICU Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose', 'description': 'Group randomized to high-dose oxytocin regimen'}, {'id': 'OG001', 'title': 'Low-dose', 'description': 'Group randomized to low-dose oxytocin regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization through 6 weeks postpartum', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Composite Neonatal Morbidity Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose', 'description': 'Group randomized to high-dose oxytocin regimen'}, {'id': 'OG001', 'title': 'Low-dose', 'description': 'Group randomized to low-dose oxytocin regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 6 weeks of delivery', 'description': 'Apgar score \\<5 at 5 min, arterial cord pH \\<7.0 or base deficit \\>12 mmol/dL, perinatal death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of NICU Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose', 'description': 'Group randomized to high-dose oxytocin regimen'}, {'id': 'OG001', 'title': 'Low-dose', 'description': 'Group randomized to low-dose oxytocin regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 6 weeks of delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose', 'description': 'Group randomized to high-dose oxytocin regimen'}, {'id': 'OG001', 'title': 'Low-dose', 'description': 'Group randomized to low-dose oxytocin regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 6 weeks of delivery', 'description': 'Duration of hospitalization for delivery', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neonatal Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose', 'description': 'Group randomized to high-dose oxytocin regimen'}, {'id': 'OG001', 'title': 'Low-dose', 'description': 'Group randomized to low-dose oxytocin regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 6 weeks of delivery', 'description': 'Duration of birth hospitalization', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Perception of the Labor, Birth, and Postpartum Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose', 'description': 'Group randomized to high-dose oxytocin regimen'}, {'id': 'OG001', 'title': 'Low-dose', 'description': 'Group randomized to low-dose oxytocin regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '16'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed within 12-96 hours after delivery', 'description': "Patient perception as measured using the validated Childbirth Perception Scale. This is a 12-item instrument developed to assess a patient's perception of the labor and delivery experience. Each item is formatted on a four-point scale ranging from 0 to 3. The overall range in total score is 1-36 with higher scores indicating a less positive perception.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Labor Agentry Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-dose', 'description': 'Group randomized to high-dose oxytocin regimen'}, {'id': 'OG001', 'title': 'Low-dose', 'description': 'Group randomized to low-dose oxytocin regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '139.5', 'groupId': 'OG000', 'lowerLimit': '138', 'upperLimit': '174'}, {'value': '185', 'groupId': 'OG001', 'lowerLimit': '169', 'upperLimit': '190'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed within 12-96 hours after delivery', 'description': "Patient perception of labor agentry as measured using validated Labor Agentry Scale. This 29-item tool was developed to assess a patient's expectancies and experiences with control in labor. Each item is scored 1 to 7. Overall total score can range from 29-201 with higher scores indicated greater perceived control during childbirth.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High-dose Oxytocin Regimen', 'description': 'Starting dose 6 mU/min and increased by 6 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.\n\nHigh-dose oxytocin: Starting dose 6 mU/min and increased by 6 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.'}, {'id': 'FG001', 'title': 'Low-dose Oxytocin Regimen', 'description': 'Starting dose 2 mU/min and increased by 2 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.\n\nLow-dose oxytocin: Starting dose 2 mU/min and increased by 2 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High-dose', 'description': 'Group randomized to high-dose oxytocin regimen'}, {'id': 'BG001', 'title': 'Low-dose', 'description': 'Group randomized to low-dose oxytocin regimen'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Maternal age', 'categories': [{'measurements': [{'value': '25.5', 'spread': '4.53', 'groupId': 'BG000'}, {'value': '26.9', 'spread': '6.06', 'groupId': 'BG001'}, {'value': '26.2', 'spread': '5.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', '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/Ethnicity, Customized', 'classes': [{'title': 'Race/ethnicity', 'categories': [{'title': 'Non-Hispanic Black', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Non-Hispanic White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Delivery BMI, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.8', 'groupId': 'BG000', 'lowerLimit': '34.9', 'upperLimit': '45.3'}, {'value': '41.4', 'groupId': 'BG001', 'lowerLimit': '35.1', 'upperLimit': '45.1'}, {'value': '41.6', 'groupId': 'BG002', 'lowerLimit': '35.1', 'upperLimit': '45.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Delivery BMI ≥40', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational age, continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.0', 'groupId': 'BG000', 'lowerLimit': '37.1', 'upperLimit': '40.1'}, {'value': '39.1', 'groupId': 'BG001', 'lowerLimit': '38.0', 'upperLimit': '40.1'}, {'value': '38.7', 'groupId': 'BG002', 'lowerLimit': '37.6', 'upperLimit': '40.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Admission Bishop score <5', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Maximum oxytocin dose', 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'groupId': 'BG000', 'lowerLimit': '6', 'upperLimit': '36'}, {'value': '10', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '26'}, {'value': '13', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '36'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mu/min', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-21', 'size': 336314, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-24T13:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Participants, research staff, and clinical care providers will be blinded to the dosing regimen.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-08', 'studyFirstSubmitDate': '2022-02-25', 'resultsFirstSubmitDate': '2022-12-26', 'studyFirstSubmitQcDate': '2022-03-16', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-03', 'studyFirstPostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Delivered by Cesarean', 'timeFrame': 'Until delivery'}], 'secondaryOutcomes': [{'measure': 'Duration of Time From Start of Induction to Delivery', 'timeFrame': 'From start of induction to delivery', 'description': 'Time from start of induction with medication or Foley catheter until delivery'}, {'measure': 'Duration of the First Stage of Labor', 'timeFrame': 'From start of induction to delivery', 'description': 'Time from start of labor to complete dilation'}, {'measure': 'Occurrence of Tachysystole', 'timeFrame': 'From start of induction to delivery', 'description': 'Defined as more than 5 contractions in 10 minutes averaged over 30 minutes'}, {'measure': 'Incidence of Uterine Rupture', 'timeFrame': 'From start of induction to delivery', 'description': 'Defined as a complete disruption of all uterine layers including serosa'}, {'measure': 'Incidence of Clinical Chorioamnionitis', 'timeFrame': 'From start of induction thorough delivery', 'description': 'Defined based on clinical diagnosis as documented by the clinical care team'}, {'measure': 'Incidence of Postpartum Maternal Infectious Morbidity', 'timeFrame': 'Within 6 weeks following delivery', 'description': 'Defined as a composite outcome of endomyometritis, puerperal sepsis, or surgical site infection as documented in the the clinical record'}, {'measure': 'Incidence of Maternal Death', 'timeFrame': 'Within 6 weeks of delivery'}, {'measure': 'Incidence of Immediate Postpartum Hemorrhage', 'timeFrame': 'Within 24 hours of delivery', 'description': 'Defined as \\>1000 mL of blood loss within 24 hours of delivery'}, {'measure': 'Incidence of Maternal Blood Transfusion', 'timeFrame': 'From randomization through hospital discharge up to 6 weeks portpartum', 'description': 'Defined as need for blood transfusion'}, {'measure': 'Incidence of Maternal ICU Admission', 'timeFrame': 'From randomization through 6 weeks postpartum'}, {'measure': 'Incidence of Composite Neonatal Morbidity Outcomes', 'timeFrame': 'Within 6 weeks of delivery', 'description': 'Apgar score \\<5 at 5 min, arterial cord pH \\<7.0 or base deficit \\>12 mmol/dL, perinatal death'}, {'measure': 'Incidence of NICU Admission', 'timeFrame': 'Within 6 weeks of delivery'}, {'measure': 'Maternal Length of Stay', 'timeFrame': 'Within 6 weeks of delivery', 'description': 'Duration of hospitalization for delivery'}, {'measure': 'Neonatal Length of Stay', 'timeFrame': 'Within 6 weeks of delivery', 'description': 'Duration of birth hospitalization'}, {'measure': 'Perception of the Labor, Birth, and Postpartum Experience', 'timeFrame': 'Assessed within 12-96 hours after delivery', 'description': "Patient perception as measured using the validated Childbirth Perception Scale. This is a 12-item instrument developed to assess a patient's perception of the labor and delivery experience. Each item is formatted on a four-point scale ranging from 0 to 3. The overall range in total score is 1-36 with higher scores indicating a less positive perception."}, {'measure': 'Labor Agentry Score', 'timeFrame': 'Assessed within 12-96 hours after delivery', 'description': "Patient perception of labor agentry as measured using validated Labor Agentry Scale. This 29-item tool was developed to assess a patient's expectancies and experiences with control in labor. Each item is scored 1 to 7. Overall total score can range from 29-201 with higher scores indicated greater perceived control during childbirth."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oxytocin', 'Pregnant patients with obesity', 'Induction of labor'], 'conditions': ['Pregnant Patients With Obesity']}, 'descriptionModule': {'briefSummary': 'Pregnant patients with obesity are more likely to undergo induction of labor and have a higher risk of failed induction compared to patients with normal weight. The association between maternal obesity and labor dysfunction leading to cesarean delivery is poorly understood. Oxytocin is the mostly common medication used in induction of labor, yet optimal dosing of this medication is unknown. Studies have suggested that patients with obesity may be less responsive to oxytocin. This trial will compare a high and low dose oxytocin dosing regimen for the induction of labor in women with obesity.', 'detailedDescription': "This study is a pragmatic single center randomized, double blinded controlled trial. Nulliparous women with a pre-pregnancy body mass index (BMI) ≥30 kg/m2 undergoing induction of labor at ≥37 weeks' gestation will be eligible for enrollment. Women will be randomly allocated to receive oxytocin using either a high-dose or low-dose regimen. Patients, providers, and research staff will be blinded to the dosing regimen. All other aspects of obstetric management will be at the discretion of the patient's clinical care team.\n\nPostpartum maternal, neonatal, and delivery outcomes will be collected. Postpartum data through hospital discharge will be collected from the medical record. Information about complications following hospital discharge through 6 weeks after delivery will be collected during a research follow-up telephone call performed 6-8 weeks following delivery."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Nulliparity\n2. Maternal age \\>18 years\n3. Gestational age ≥37w0d\n4. Induction of labor, defined as initiation of labor with medication or intracervical Foley catheter in a patient without observed spontaneous cervical change and \\<6 contractions per hour (average of one contraction every 10 minutes) at the time of initial presentation. Women with prelabor rupture of membranes (PROM) can be included if the other criteria are also met with regards to cervical dilation and contractions.\n5. Singleton gestation\n6. Cephalic presentation\n7. Indication for oxytocin use in the first stage of labor\n8. No contraindication to labor or vaginal delivery\n9. Pre-pregnancy BMI ≥30 kg/m2 based on patient report and confirmed by pre-pregnancy or first trimester weight as recorded in the medical record\n10. Cervical dilation ≤4 cm at time of initiation of induction\n\nExclusion Criteria:\n\n1. Fetal demise\n2. Major fetal congenital malformation or known chromosomal abnormality\n3. Prior uterine surgery (e.g., cesarean, myomectomy)\n4. Non-reassuring fetal wellbeing as indication for induction\n5. Intraamniotic infection suspected or diagnosed prior to randomization\n6. Non-English\n7. Multifetal gestation\n8. Gestational age \\<37 weeks\n9. Spontaneous labor\n10. Cervical dilation \\> 4 cm at initiation of induction\n11. Initiation of oxytocin in the second stage of labor\n12. Use of oxytocin prior to randomization or planned use of oxytocin with foley catheter for cervical ripening\n13. Fetal malpresentation\n14. Estimated fetal weight \\>4500 g in a patient with diabetes, or estimated fetal weight \\>5000 g in a non-diabetic patient\n15. Abnormal placentation (e.g. previa, suspected placenta accreta spectrum)\n16. Physician/provider or patient refusal'}, 'identificationModule': {'nctId': 'NCT05289869', 'acronym': 'HILIO-PILOT', 'briefTitle': 'A Pilot Study: High Versus Low Oxytocin Dosing for Induction of Labor in Pregnant Patients With Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'The HILIO Trial: High vs. Low Oxytocin Dosing for Induction of Labor in Pregnant Patients With Obesity- PILOT STUDY', 'orgStudyIdInfo': {'id': '2021H0432'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-dose oxytocin regimen', 'description': 'Starting dose 6 mU/min and increased by 6 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.', 'interventionNames': ['Drug: High-dose oxytocin']}, {'type': 'EXPERIMENTAL', 'label': 'Low-dose oxytocin regimen', 'description': 'Starting dose 2 mU/min and increased by 2 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.', 'interventionNames': ['Drug: Low-dose oxytocin']}], 'interventions': [{'name': 'High-dose oxytocin', 'type': 'DRUG', 'description': 'Starting dose 6 mU/min and increased by 6 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.', 'armGroupLabels': ['High-dose oxytocin regimen']}, {'name': 'Low-dose oxytocin', 'type': 'DRUG', 'description': 'Starting dose 2 mU/min and increased by 2 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.', 'armGroupLabels': ['Low-dose oxytocin regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSCI, Assistant Professor', 'investigatorFullName': 'Heather Frey', 'investigatorAffiliation': 'Ohio State University'}}}}