Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT01156194
Status:
COMPLETED
Last Update Posted:
2012-02-22
First Post:
2010-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Homeopathic Remedy for the Third Stage of Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-19', 'studyFirstSubmitDate': '2010-07-01', 'studyFirstSubmitQcDate': '2010-07-01', 'lastUpdatePostDateStruct': {'date': '2012-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin levels at 2d postpartum', 'timeFrame': '48h'}], 'secondaryOutcomes': [{'measure': 'incidence of endometritis', 'timeFrame': '7d'}, {'measure': 'time to extrusion of placenta following birth', 'timeFrame': '24h'}, {'measure': 'duration of lochiae secretion', 'timeFrame': '7days'}, {'measure': 'duration of third stage of labor', 'timeFrame': '24h'}, {'measure': 'assessment of quality-of-life parameters', 'timeFrame': '7 days'}, {'measure': 'assess toxic effects of the homeopathic remedies', 'timeFrame': '7 days'}, {'measure': 'serum cortisol levels', 'timeFrame': 'within 12h postpartum'}, {'measure': 'state of perineum postpartum', 'timeFrame': '48h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['third stage, labor, postpartum hemorrhage, homeopathy, arnica, bellis perennis'], 'conditions': ['Third Stage of Labor']}, 'descriptionModule': {'briefSummary': 'The homeopathic remedy consisting of Arnica and Bellis perennis have been shown in a previous pilot study (n=33) to reduce blood loss during the third stage of delivery, when compared with placebo treatment. The purpose of this study is to repeat the previous methodology, this time on a larger population.\n\n210 parturients will be randomized to one of three groups: Arnica montana C6 and Bellis perennis C6 (n=70), Arnica montana C30 and Bellis perennis C30 (n=70), or double placebo (n=70).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy women in 3rd stage of labor\n* age 20-35\n* second to fifth gestation\n* spontaneous PV delivery\n* term delivery (37-42nd weeks)\n\nExclusion Criteria:\n\n* scarred uterus\n* multifetal pregnancy\n* history of bleeding problems\n* caesarian section delivery\n* chorioamnionitis\n* pregnancy-induced hypertension\n* gestational diabetes mellitus\n* polyhydramnios, premature rupture of membrane\n* suspected macrosomy/SGA'}, 'identificationModule': {'nctId': 'NCT01156194', 'briefTitle': 'Homeopathic Remedy for the Third Stage of Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'officialTitle': 'Effect of a Homeopathic Remedy on the Third Stage of Delivery: a Prospective, Randomized, Double-Blind Study.', 'orgStudyIdInfo': {'id': 'ArBel.2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Homeopathy 1', 'description': 'Arnica montana C6 and Bellis perennis C6', 'interventionNames': ['Drug: Homeopathy 1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Homeopathy 2', 'description': 'Arnica montana C30 and Bellis perennis C30', 'interventionNames': ['Drug: Homeopathy 2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'globules identical to true comparators', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Homeopathy 1', 'type': 'DRUG', 'description': 'Arnica montana C6 and Bellis perennis C6', 'armGroupLabels': ['Homeopathy 1']}, {'name': 'Homeopathy 2', 'type': 'DRUG', 'description': 'Arnica montana C30 and Bellis perennis C30', 'armGroupLabels': ['Homeopathy 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'globule identical to true homeopathy comparators', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91031', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Maternity Ward, Shaare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Center for Integrative Complementary Medicine', 'investigatorFullName': 'Menachem Oberbaum', 'investigatorAffiliation': 'Shaare Zedek Medical Center'}}}}