Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT03784092
Status:
UNKNOWN
Last Update Posted:
2018-12-21
First Post:
2018-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect Mobility During Induction of Labor on Time to Delivery. A Randomized Controlled Trial
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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 224}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2018-12-19', 'studyFirstSubmitQcDate': '2018-12-20', 'lastUpdatePostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to delivery', 'timeFrame': 'labor ( catheter placement till delivery completion)', 'description': 'time from extra amniotic catheter placement till delivery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Labor Onset and Length Abnormalities']}, 'descriptionModule': {'briefSummary': 'this is a andomized controlled trial the evaluates the effect of enhanced mobility, controlled via electronic pedometers, during induction of labor by extra amniotic balloon on time to delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women\n* low risk pregnancies\n* singlelton\n* vertex position\n* undergoing labor induction with extra amniotic catheter\n* no contraindication for enhanced mobility\n\nExclusion Criteria:\n\n* medical recommendation for limited mobility\n* status post cesarean delivery\n* twin pregnancy\n* premature rupture of membranes\n* severe preeclampsia\n* maternal comorbidity'}, 'identificationModule': {'nctId': 'NCT03784092', 'briefTitle': 'Effect Mobility During Induction of Labor on Time to Delivery. A Randomized Controlled Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Wolfson Medical Center'}, 'officialTitle': 'The Effect of Enhanced Mobility, Controlled Via Electronic Pedometers, During Induction of Labor by Extra Amniotic Balloon on Time to Delivery. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '0201-18-womc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control'}, {'type': 'EXPERIMENTAL', 'label': 'feedback', 'interventionNames': ['Other: feedback']}], 'interventions': [{'name': 'feedback', 'type': 'OTHER', 'description': 'feedback by electronic pedometers regarding patient mobility while undergoing labor induction', 'armGroupLabels': ['feedback']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Noa Gonen', 'investigatorAffiliation': 'Wolfson Medical Center'}}}}