Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-31 @ 6:19 PM
Study NCT ID:
NCT03086967
Status:
COMPLETED
Last Update Posted:
2022-11-30
First Post:
2017-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cervical Ripening With a Double-lumen Balloon Catheter for Six Versus Twelve Hours
Sponsor:
Organization:
Raw JSON
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introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 1, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'incorrect foley placement', 'notes': 'foley bulb was not placed in the cervix', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time From Foley Bulb Placement to Time of Delivery.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Six Hour', 'description': 'Placement of foley catheter and extrusion 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'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time to Delivery of Trial of Labor After Cesarean Section', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Six Hour', 'description': 'Placement of foley catheter and extrusion after 6 hours followed by induction.\n\nDouble-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices'}, {'id': 'OG001', 'title': 'Twelve Hour', 'description': 'Placement of foley catheter and extrusion after 12 hours followed by induction.\n\nDouble-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices'}], 'classes': [{'categories': [{'measurements': [{'value': '20.62', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '27.18', 'spread': '11.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.133', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Time (hours) to delivery', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '1 Minute Apgar Score of Trial of Labor After Cesarean Section', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Six Hour', 'description': 'Placement of foley catheter and extrusion after 6 hours followed by induction.\n\nDouble-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices'}, {'id': 'OG001', 'title': 'Twelve Hour', 'description': 'Placement of foley catheter and extrusion after 12 hours followed by 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'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Six Hour', 'description': 'Placement of foley catheter and extrusion after 6 hours followed by induction.\n\nDouble-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices'}, {'id': 'BG001', 'title': 'Twelve Hour', 'description': 'Placement of foley catheter and extrusion after 12 hours followed by induction.\n\nDouble-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.8', 'spread': '5.96', 'groupId': 'BG000'}, {'value': '24.33', 'spread': '5.92', 'groupId': 'BG001'}, {'value': '24.6', 'spread': '5.94', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '200', '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': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '34', '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': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Maternal Weight', 'classes': [{'categories': [{'measurements': [{'value': '89.0', 'spread': '20.6', 'groupId': 'BG000'}, {'value': '85.9', 'spread': '19.0', 'groupId': 'BG001'}, {'value': '87.5', 'spread': '19.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Maternal BMI', 'classes': [{'categories': [{'measurements': [{'value': '34.1', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '32.7', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '33.4', 'spread': '7.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gestational Age', 'classes': [{'categories': [{'measurements': [{'value': '39.4', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '39.5', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '39.5', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'wks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gravidity', 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '1.4', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '1.4', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'events', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Parity', 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '0.1', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '0.1', 'spread': '0.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Events', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Bishop score on admission', 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '3.2', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '3.2', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Bishop score is used to rate the readiness of the cervix for labor. Score ranges from 0 to 13. A Bishop score of less than 6 means that the cervix may not be ready for labor.', 'unitOfMeasure': 'Score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Indication for Induction', 'classes': [{'title': 'Postdates', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Oligohydramnios', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Maternal Health Condition', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}, {'title': 'Fetal Health Condition', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'concomitant medications during induction', 'classes': [{'title': 'Magnesium Sulfate', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Pitocin w Foley Bulb', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Pitocin after Foley Bulb', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}]}, {'title': 'Misoprostol prior to Foley Bulb', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'Misoprostol w Foley Bulb', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Epidural', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-09', 'studyFirstSubmitDate': '2017-02-21', 'resultsFirstSubmitDate': '2022-09-09', 'studyFirstSubmitQcDate': '2017-03-16', 'lastUpdatePostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-09', 'studyFirstPostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time From Foley Bulb Placement to Time of Delivery.', 'timeFrame': 'Change in time to delivery following bulb insertion for 6 hours up to 72 hours', 'description': 'Time in hours to delivery following use of foley catheter'}, {'measure': 'Time to Delivery of Trial of Labor After Cesarean Section', 'timeFrame': 'Time (hours) to delivery'}, {'measure': '1 Minute Apgar Score of Trial of Labor After Cesarean Section', 'timeFrame': '1 minute Apgar score following birth', 'description': 'The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.'}], 'secondaryOutcomes': [{'measure': 'Time From Foley Bulb Placement to Extrusion', 'timeFrame': 'Hour 6, Hour 12', 'description': 'Time in hours from foley bulb placement to extrusion'}, {'measure': 'Mode of Delivery--Number of Participants Having Cesarean Delivery', 'timeFrame': 'Hour Six, Hour 12'}, {'measure': 'Bacterial Infection (Chorioamnionitis)', 'timeFrame': 'Hour Six, Hour 12'}, {'measure': 'Endometritis', 'timeFrame': 'Hour 6, Hour 12'}, {'measure': '1 Minute Apgar Score', 'timeFrame': '1 minute Apgar score following birth', 'description': 'The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.'}, {'measure': '5 Minute Apgar Score', 'timeFrame': '5 minute Apgar score following birth', 'description': 'The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.'}, {'measure': 'Time to Foley Bulb Extrusion of Trial of Labor After Cesarean Section', 'timeFrame': 'Time to foley bulb extrusion'}, {'measure': '5 Minute Apgar Score of Trial of Labor After Cesarean Section', 'timeFrame': '5 Minute Apgar Score following birth', 'description': 'The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cervical ripening', 'double lumen catheter'], 'conditions': ['Induction of Labor Affected Fetus / Newborn']}, 'descriptionModule': {'briefSummary': 'The Foley catheter is a safe, effective method for cervical ripening. Limited data exists to indicate ideal time of placement for optimal cervical ripening prior to induction. The proposed study is a randomized control trial to determine if shortening placement from 12 to 6 hours of foley catheter can decrease time from start of induction to delivery. The prediction is that shortening foley bulb placement will result in shorter induction times, increased patient satisfaction and decreased length of stay on labor and delivery with secondary decreased medical costs.', 'detailedDescription': "Objective: To determine whether a double-lumen balloon catheter requires twelve hours in the cervical canal to achieve its maximal cervical dilation. It is the hypothesis that the maximum cervical dilation and benefits of a double lumen foley catheter are achieved within the initial six hours after placement.\n\nStudy Design:\n\nOverview: All eligible patients with a singleton pregnancy at 37 weeks gestational age or greater who are presenting for a clinically/ medically indicated induction with an unfavorable cervical exam will be invited to participate. As per the American College of Obstetricians and Gynecologists (ACOG) guidelines, all inductions performed prior to 39 weeks are medically indicated. Medical indications for induction prior to 39 weeks include but are not limited to preeclampsia, oligohydramnios and growth restriction. Upon admission to Labor and Delivery, women will be assessed for eligibility by an obstetric physician. A digital cervical examination will be performed and a Bishop score assigned. Patients with a Bishop score ≤ 6 are thought to benefit from a cervical ripening agent and the participants will be randomized based on parity at this point.\n\nType of Study: This study will be a prospective, randomized clinical control trial with human subjects.\n\nMaterials and Methods:\n\nA qualified obstetric provider will provide eligible women with details of the study, including study objectives and methods. Consent will be obtained and witnessed from patients who elect to participate. Enrollment and randomization in the study will then occur. Patients will be randomized to the two groups using computer generated random numbers. The randomization will be stratified based on parity (i.e., women who have had any prior vaginal delivery above 20 weeks gestation v. women who have not). A foley bulb will then be placed by a qualified obstetric provider. Foley bulb will be inserted with or without speculum technique and with or without use of a stylet. In accordance with the standard of care, sterile saline will be placed in the intrauterine and vaginal balloon as tolerated by the patient for no more than a maximum of 80 cc in each balloon. The use of concomitant low dose pitocin with the foley bulb will be at the discretion of the admitting obstetric team. If the patient's foley bulb does not spontaneously expel within the maximum allotted time, they will be manually removed at six or twelve hours. At the time of manual removal or expulsion of the foley balloon, the patient's cervix will be checked by an experienced obstetric provider. As per usual protocol, additional cervical ripening and labor induction will proceed per managing obstetric team.\n\nIndependent Variables:\n\nData collection will include the independent variables of maternal age, parity, BMI, race (Caucasian, African American, Hispanic, Asian, other), Bishop Score, use of magnesium and epidural use. Data collection of independent fetal variables will include gestational age and estimated fetal weight.\n\nOutcome Variables:\n\nThe primary outcome will be time from foley bulb placement to time of delivery. Secondary outcomes will include time from foley bulb placement to extrusion and rate of cesarean section. Additional comparison variables include: neonatal weight, APGAR scores and intrapartum and postpartum infection rates."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Intrauterine pregnancy at 37 weeks gestational age or greater as determined by best obstetrical dating criteria\n2. Singleton gestation\n3. Vertex presentation\n4. Clinically adequate pelvis\n5. Bishop Score less than or equal to 6\n6. 16 years and older\n\n * North Carolina state law provides for the emancipation of minors, Chapter 7B-Article 35.\n\nExclusion Criteria:\n\n1. Any maternal or fetal contraindication to vaginal delivery\n2. Known uterine anomaly\n3. Multifetal gestation\n4. Estimated fetal weight of 4500 gm or greater\n5. Ruptured membranes'}, 'identificationModule': {'nctId': 'NCT03086967', 'briefTitle': 'Cervical Ripening With a Double-lumen Balloon Catheter for Six Versus Twelve Hours', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Cervical Ripening With a Double-lumen Balloon Catheter for Six Versus Twelve Hours', 'orgStudyIdInfo': {'id': '06-13-03B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Six Hour', 'description': 'Placement of foley catheter and extrusion after 6 hours followed by induction.', 'interventionNames': ['Device: Double-lumen balloon catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Twelve Hour', 'description': 'Placement of foley catheter and extrusion after 12 hours followed by induction.', 'interventionNames': ['Device: Double-lumen balloon catheter']}], 'interventions': [{'name': 'Double-lumen balloon catheter', 'type': 'DEVICE', 'otherNames': ['foley bulb'], 'description': 'introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices', 'armGroupLabels': ['Six Hour', 'Twelve Hour']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28232', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Susan A Bliss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}