Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-02-20 @ 10:44 PM
Study NCT ID:
NCT03025503
Status:
UNKNOWN
Last Update Posted:
2017-01-19
First Post:
2016-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nipple Stimulation for Labor Induction
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': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-16', 'studyFirstSubmitDate': '2016-12-18', 'studyFirstSubmitQcDate': '2017-01-16', 'lastUpdatePostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression to active labor as measured by the Bishop score', 'timeFrame': '6 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Delivery Delayed']}, 'descriptionModule': {'briefSummary': 'This study will examine the use of nipple stimulation for cervical ripening in women who present to the labor and delivery ward after their water has broken but have a contraindication to prostaglandins.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Week 37 + 0 and on\n* PROM (premature rupture of membranes)\n* Multiparity (birth sixth or higher) or TOLAC (trial of labor after Caesarean section)\n* Not in active labor - without regular contractions fetal monitor, cervical dilation \\< 4 cm and effacement \\< 80%.\n\nExclusion Criteria:\n\n* Water break \\> 24 hours at the time of admission to the delivery room\n* Active vaginal bleeding with suspected placental abruption\n* Maternal fever\n* Multifetal pregnancy\n* Women with contraindication for vaginal birth\n* Preeclampsia\n* IUGR (intrauterine growth restriction)\n* Macrosomia\n* Non-reassuring fetal heart tracing'}, 'identificationModule': {'nctId': 'NCT03025503', 'briefTitle': 'Nipple Stimulation for Labor Induction', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Nipple Stimulation for Labor Induction: Efficiency, Safety and Satisfaction Measures', 'orgStudyIdInfo': {'id': 'NippleStim-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nipple stimulation', 'interventionNames': ['Other: nipple stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'no intervention'}], 'interventions': [{'name': 'nipple stimulation', 'type': 'OTHER', 'armGroupLabels': ['nipple stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization, Jerusalem, Israel', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Drorith Hochner-Celnikier, MD', 'role': 'CONTACT', 'email': 'hochner@hadassah.org.il', 'phone': '00 972 2 5844400'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}