Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2026-04-10 @ 4:39 AM
Study NCT ID:
NCT02154932
Status:
COMPLETED
Last Update Posted:
2014-06-03
First Post:
2014-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Versus Double Dose Intra-vaginal Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}], 'ancestors': [{'id': 'D011459', 'term': 'Prostaglandins E, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-31', 'studyFirstSubmitDate': '2014-05-31', 'studyFirstSubmitQcDate': '2014-05-31', 'lastUpdatePostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the operative time', 'timeFrame': 'from skin to skin in minutes', 'description': 'The time from start till end of surgery'}, {'measure': 'intra and post-operative blood loss', 'timeFrame': 'during and 6 hours after surgery', 'description': 'collected soaked towels and sucked blood'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myomectomy, Misoprostol'], 'conditions': ['Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy']}, 'descriptionModule': {'briefSummary': 'Introduction: The study aimed to investigate the effectiveness of a single versus double dose of Prostaglandin E2 "Misoprostol, 400 microgram" during myomectomy for multiple uterine fibroids. This was a prospective randomized controlled trial comprised of 69 patients with multiple myomas undergoing myomectomy. Patients randomly allocated to either an intra-vaginal single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34 cases) or 2 doses, 3 and 1 hours, prior surgery (group B, 35 cases). Operation time, intra and post-operative blood loss, hemoglobin concentration, blood pressure and body\'s temperature were estimated and compared in both groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients had symptomatic multiple uterine fibroids (abnormal vaginal bleeding, lower abdominal dull aching pain and pelvic heaviness, subfertility or recurrent abortion)\n\nExclusion Criteria:\n\n* hypertension, cardiac and pulmonary disease, chronic endocrine or metabolic diseases such as diabetes, obesity (body mass index \\>30 kg/m2), all cases of single myoma and those known to be allergic to prostaglandin preparations.'}, 'identificationModule': {'nctId': 'NCT02154932', 'briefTitle': 'Single Versus Double Dose Intra-vaginal Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Single Versus Double Dose Intra-vaginal Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'AB123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'double dose misoprostol', 'description': '2 doses, 3 and 1 hours, prior surgery (group B, 35 cases).', 'interventionNames': ['Drug: 2 doses 400 microgram misoprostol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'single dose Misoprostol', 'description': 'intra-vaginal single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34 cases)', 'interventionNames': ['Drug: single dose misoprostol']}], 'interventions': [{'name': '2 doses 400 microgram misoprostol', 'type': 'DRUG', 'description': '2 doses 400 microgram misoprostol, 3 and 1 hours', 'armGroupLabels': ['double dose misoprostol']}, {'name': 'single dose misoprostol', 'type': 'DRUG', 'description': '1 dose, 1 hours, prior surgery', 'armGroupLabels': ['single dose Misoprostol']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'ahmed M. badawy', 'investigatorAffiliation': 'Mansoura University'}}}}