Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-16 @ 5:16 PM
Study NCT ID:
NCT05013151
Status:
UNKNOWN
Last Update Posted:
2021-08-19
First Post:
2021-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Dates and Castor Oil on the Initiation of Spontaneous Labor in Primigravida Parturients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002910', 'term': 'Chronology as Topic'}, {'id': 'D002368', 'term': 'Castor Oil'}], 'ancestors': [{'id': 'D013995', 'term': 'Time'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-08-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-18', 'studyFirstSubmitDate': '2021-08-17', 'studyFirstSubmitQcDate': '2021-08-18', 'lastUpdatePostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of spontaneous entry into labor', 'timeFrame': '2 weeks after enrollment', 'description': 'Rate of women who will enter labor spontaneously without intervention'}], 'secondaryOutcomes': [{'measure': 'Cervical ripening- Bishop score', 'timeFrame': '2 weeks after enrollment', 'description': 'Change of cervical ripening status after intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Effect of Dates and Castor Oil on Spontaneous Labor']}, 'descriptionModule': {'briefSummary': 'Finding a natural and efficient method to improve the chance of entering spontaneous labor beyond 39 weeks of gestation will address both the medical necessity and the will of many parturients to avoid medical interventions.\n\nIn this study we aim to evaluate the effect of dates and castor oil on the initiation of spontaneous labor in primigravida parturients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pregnant women who come to the obstetrical emergency department for normal check up between 39+4 and 40+2 weeks of gestation\n* Primipara\n* Bishop cervical score below 5\n* Low risk pregnancy\n* Singleton pregnancy\n* Vertex presentation\n* Women who haven't consumed dates over once a week in month prior the checkup and haven't consumed castor oil prior to enrollment.\n\nExclusion Criteria:\n\n* Any medical indication for labor induction\n* Regular contractions\n* Premature rupture of membranes\n* Women who consumed dates over once a week in month prior the checkup or consumed castor oil prior to enrollment."}, 'identificationModule': {'nctId': 'NCT05013151', 'briefTitle': 'The Effect of Dates and Castor Oil on the Initiation of Spontaneous Labor in Primigravida Parturients', 'organization': {'class': 'OTHER', 'fullName': 'Carmel Medical Center'}, 'officialTitle': 'The Effect of Dates and Castor Oil on the Initiation of Spontaneous Labor in Primigravida Parturients- a Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'CMC-21-0064-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Date consumption', 'description': 'Consumption of 6 dates a day until 41 weeks of gestation', 'interventionNames': ['Dietary Supplement: Dates']}, {'type': 'EXPERIMENTAL', 'label': 'Castor oil consumption', 'description': 'One time consumption of 60 CC of Castor oil', 'interventionNames': ['Dietary Supplement: Castor oil']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group'}], 'interventions': [{'name': 'Dates', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Consumption of 6 dates a days until 41 weeks of gestation', 'armGroupLabels': ['Date consumption']}, {'name': 'Castor oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One time consumption of 60 CC Castor oil', 'armGroupLabels': ['Castor oil consumption']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Carmel Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Nir Kugelman, MD', 'role': 'CONTACT', 'email': 'nirkug@gmail.com', 'phone': '972-546830804'}], 'overallOfficials': [{'name': 'Lena Sagi-Dain, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lady Davis Carmel Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Nir Kugelman', 'investigatorFullName': 'Nir Kugelman', 'investigatorAffiliation': 'Carmel Medical Center'}}}}