Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-22 @ 7:02 PM
Study NCT ID:
NCT02344459
Status:
COMPLETED
Last Update Posted:
2015-01-26
First Post:
2014-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-16', 'studyFirstSubmitDate': '2014-12-01', 'studyFirstSubmitQcDate': '2015-01-16', 'lastUpdatePostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bishop score greater than or equal to 6 at time of balloon catheter removal', 'timeFrame': 'until catheter removal (12 hours maximum)'}], 'secondaryOutcomes': [{'measure': 'induction to delivery time', 'timeFrame': 'The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)'}, {'measure': 'vaginal delivery time less than 24 hours from initiation of induction', 'timeFrame': '24 hours'}, {'measure': 'mode of delivery', 'timeFrame': 'The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)'}, {'measure': 'Time to catheter expulsion', 'timeFrame': 'Up to 12 hours'}, {'measure': 'Type of catheter expulsion', 'timeFrame': 'The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)', 'description': 'spontaneous vs. provider'}, {'measure': 'Epidural utilization', 'timeFrame': 'The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)'}, {'measure': 'Meconium stained amniotic fluid', 'timeFrame': 'The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)'}, {'measure': '5 minute Apgar score', 'timeFrame': 'The participants infant will be monitored from immediately to 5 minutes after birth'}, {'measure': 'Medication required to augment labor', 'timeFrame': 'The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)', 'description': 'prostaglandins, oxytocin'}, {'measure': 'Artificial rupture of membranes required to augment labor', 'timeFrame': 'The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)'}, {'measure': 'Cesarean section indications', 'timeFrame': 'The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)'}, {'measure': 'Neonatal intensive care unit admissions', 'timeFrame': 'The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)'}, {'measure': 'Chorioamnionitis', 'timeFrame': 'The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)'}, {'measure': 'birthweight', 'timeFrame': 'The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pre-induction Cervical Ripening']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to perform a randomized controlled trial to compare the efficacy of 80mL double balloon catheter versus a 30mL single catheter balloon for pre-induction cervical ripening by evaluating the change in Bishop score.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bishop score of 5 or less\n* Singleton\n* Cephalic presentation\n* Fewer than 4 contractions in 10 minutes\n* Reactive fetal monitoring\n\nExclusion Criteria:\n\n* Non-vertex presentation\n* Placenta previa\n* Vasa previa\n* Unexplained vaginal bleeding\n* Active herpes simplex virus infection\n* Non-English speaking\n* Previous attempt at an induction of labor in the current pregnancy\n* Prolapsed umbilical cord\n* More than one prior cesarean delivery or history of classical cesarean delivery\n* Patients receiving or planning to undergo exogenous prostaglandin administration as the primary induction agent'}, 'identificationModule': {'nctId': 'NCT02344459', 'briefTitle': 'Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Randomized Controlled Trial: Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening', 'orgStudyIdInfo': {'id': '36685-D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '80mL double balloon catheter (Cook catheter®)', 'interventionNames': ['Device: mechanical pre-induction cervical ripening']}, {'type': 'ACTIVE_COMPARATOR', 'label': '30mL single Foley balloon catheter', 'interventionNames': ['Device: mechanical pre-induction cervical ripening']}], 'interventions': [{'name': 'mechanical pre-induction cervical ripening', 'type': 'DEVICE', 'description': 'The balloon catheters have been used to provide mechanical dilation to the cervix as a method of pre-induction cervical ripening.', 'armGroupLabels': ['30mL single Foley balloon catheter', '80mL double balloon catheter (Cook catheter®)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kara K Hoppe, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Maternal Fetal Medicine Fellow', 'investigatorFullName': 'Kara Hoppe', 'investigatorAffiliation': 'University of Washington'}}}}