Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-01-04 @ 2:30 AM
Study NCT ID:
NCT00468520
Status:
COMPLETED
Last Update Posted:
2011-03-02
First Post:
2007-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Oxytocin for Preinduction Ripening With a Foley catheter--a Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-28', 'studyFirstSubmitDate': '2007-05-01', 'studyFirstSubmitQcDate': '2007-05-01', 'lastUpdatePostDateStruct': {'date': '2011-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delivery rate (proportion)', 'timeFrame': 'Within 24 hours'}], 'secondaryOutcomes': [{'measure': 'vaginal delivery rate', 'timeFrame': 'within 24 hours'}, {'measure': 'use of anesthesia/analgesia', 'timeFrame': 'during induction and labor'}, {'measure': 'overall complication rate (composite)'}, {'measure': 'duration of induction and labor'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['induction of labor', 'cervical ripening', 'Foley catheter', 'oxytocin'], 'conditions': ['Pregnancy', 'Induced Labor', 'Cervical Ripening']}, 'referencesModule': {'references': [{'pmid': '18515515', 'type': 'DERIVED', 'citation': 'Pettker CM, Pocock SB, Smok DP, Lee SM, Devine PC. Transcervical Foley catheter with and without oxytocin for cervical ripening: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1320-6. doi: 10.1097/AOG.0b013e31817615a0.'}]}, 'descriptionModule': {'briefSummary': 'The transcervical Foley catheter (TFC) is a proven and effective mode of cervical ripening. It is common practice to use TFC with simultaneous low-dose oxytocin under the assumption that the combination results in a more successful labor induction. Scientific validation of this practice is lacking. We seek to determine if the addition of oxytocin to TFC improves induction success.', 'detailedDescription': 'This is a prospective, randomized trial that aims to enroll 200 singleton pregnancies presenting for preinduction ripening. Patients will be randomized to receive either TFC alone (control) or TFC plus low-dose oxytocin (treatment). Providers will not blinded to use of oxytocin and labor was managed according to routine obstetric protocols. This study is powered to detect a 20% difference in the proportion of patients delivered within 24 hours, the primary outcome. Secondary outcomes are related to vaginal delivery rate, duration of induction, complications, and pain management.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* singleton gestation\n* presenting for induction as determined by their primary obstetrical provider\n* with fetuses in cephalic presentation\n* gestational age greater than 23 weeks\n\nExclusion Criteria:\n\n* any condition precluding vaginal delivery\n* estimated fetal weight \\>4500 grams\n* a previous attempt at ripening or induction during the pregnancy\n* clinically significant cervical or vaginal infection\n* chorioamnionitis\n* HIV\n* hepatitis B or C\n* unexplained vaginal bleeding\n* low-lying placenta\n* abnormal cervical anatomy or cervical cerclage\n* latex allergy'}, 'identificationModule': {'nctId': 'NCT00468520', 'briefTitle': 'Adjuvant Oxytocin for Preinduction Ripening With a Foley catheter--a Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'A Prospective, Randomized Trial of Transcervical Foley Catheter With or Without Oxytocin for Preinduction Cervical Ripening', 'orgStudyIdInfo': {'id': 'WIRB 20030859'}}, 'armsInterventionsModule': {'interventions': [{'name': 'low dose oxytocin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10068', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Patricia C Devine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}}}}