Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-02-27 @ 3:13 AM
Study NCT ID:
NCT03724760
Status:
COMPLETED
Last Update Posted:
2019-11-05
First Post:
2018-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pedometers for the Enhancement of Post Cesarean Mobility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051346', 'term': 'Mobility Limitation'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 291}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-03', 'studyFirstSubmitDate': '2018-10-29', 'studyFirstSubmitQcDate': '2018-10-29', 'lastUpdatePostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of steps', 'timeFrame': '48 hours', 'description': 'Number of steps taken by patient as recirded by pedometer'}], 'secondaryOutcomes': [{'measure': 'Number of participants with a postpartum complication composite', 'timeFrame': '48 hours', 'description': 'Composite of postpartum complications, including infectious (endometritis, wound), blood product transfusion'}, {'measure': 'Number of analgesic doses', 'timeFrame': '48 hours', 'description': 'Number of doses of analgesics consumed by patient'}, {'measure': 'Length of hospitalization', 'timeFrame': 'From 72 hours to one week', 'description': 'Duration of postpartum hospitalization'}, {'measure': 'Number of thromboembolic events', 'timeFrame': 'Six weeks', 'description': 'Thromboembolic events during the post partum period, including deep vein thrombosis and pulmonary emboli'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mobility Limitation']}, 'referencesModule': {'references': [{'pmid': '32459426', 'type': 'DERIVED', 'citation': 'Ganer Herman H, Kleiner I, Tairy D, Gonen N, Ben Zvi M, Kovo M, Bar J, Weiner E. Effect of Digital Step Counter Feedback on Mobility After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2020 Jun;135(6):1345-1352. doi: 10.1097/AOG.0000000000003879.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial, planned to study the effects of pedometers (digital step counters) on patient mobility following cesarean delivery. The investigators plan to randomize patients at high risk for thromboembolic events to participants with a personalized repeated feedback approach based on pedometer results, versus participants with no feedback to pedometer results.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients following cesarean delivery\n* Consent to participation\n* No medical recommendation for bed rest and limited mobility\n* Meet any of the following criteria for high risk for thromboembolic complications - preeclampsia, chronic disease (reumatic, inflammatory bowel disease), obese, smoker \\> 10 cigaretts a day, age \\>35, substantial limb varicose, multiple gestation, multiparity (\\> deliveries), emergent surgery, thrombophilia.\n\nExclusion Criteria:\n\n* Refusal to participate\n* Medical recommendation to limit mobility'}, 'identificationModule': {'nctId': 'NCT03724760', 'briefTitle': 'Pedometers for the Enhancement of Post Cesarean Mobility', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Wolfson Medical Center'}, 'officialTitle': 'Using Pedometers for the Enhancement of Post Caesarean Mobility in High Risk Patients Using a Personalized Repeated Feedback Approach - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '0165-18-WOMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Feedback', 'description': 'Patients in this arm will wear a pedometer for two days following cesarean delivery. During this period, they will recieve feedback regrding the number of steps taken by them at two time points.', 'interventionNames': ['Other: personalized repeated feedback approach']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients in this arm will wear a pedometer for two days following cesarean delivery. During this period, they will recieve no feedback regrding the number of steps taken by them.'}], 'interventions': [{'name': 'personalized repeated feedback approach', 'type': 'OTHER', 'description': 'Feedback on number of steps taken by patint, as recorded by pedometers, provided by research team', 'armGroupLabels': ['Feedback']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Holon', 'country': 'Israel', 'facility': 'Edith Wolfson Medical Center', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}], 'overallOfficials': [{'name': 'Hadas Ganer Herman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Obstetrics and Gynecology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hadas Ganer Herman', 'investigatorAffiliation': 'Wolfson Medical Center'}}}}