Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-04-15 @ 1:53 AM
Study NCT ID:
NCT02061657
Status:
COMPLETED
Last Update Posted:
2014-08-12
First Post:
2014-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Misoprostol on Blood Loss In Myomectomy Operations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-09', 'studyFirstSubmitDate': '2014-02-11', 'studyFirstSubmitQcDate': '2014-02-11', 'lastUpdatePostDateStruct': {'date': '2014-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraoperative blood loss', 'timeFrame': 'time from peritoneum opening till its closure around (1 Hour)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Leiomyoma']}, 'referencesModule': {'references': [{'pmid': '26174128', 'type': 'DERIVED', 'citation': 'Abdel-Hafeez M, Elnaggar A, Ali M, Ismail AM, Yacoub M. Rectal misoprostol for myomectomy: A randomised placebo-controlled study. Aust N Z J Obstet Gynaecol. 2015 Aug;55(4):363-8. doi: 10.1111/ajo.12359. Epub 2015 Jul 14.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this research work is to assess the effect of using single preoperative dose of rectal misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications', 'detailedDescription': 'This study is a randomized, double-blind, controlled study that will be conducted in Ain Shams University Maternity Hospital.\n\nA total of 50 women scheduled to undergo myomectomy for symptomatic uterine myoma will be included in this study after taking their consent for this clinical trial after full explanation of the trial.\n\nThe total of 50 included patients will be divided into two groups: Group A (Study group;): will Include 25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.Group B (Control group): will Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premenopausal patients aged between 35 to 50 years old.\n* Five or less symptomatic uterine myomas .\n* Maximum diameter of the largest myoma is 6 cm .\n* All myomas are subserous or intramural.\n* Uterine size less than 24 weeks pregnancy\n\nExclusion Criteria:\n\n* History of previous surgery.\n* Allergy to Misoprostol.\n* Hypertension.\n* Cardiac and Pulmonary diseases.\n* Patients who have bleeding disorders.\n* Anemia (Hb \\< 10g %).\n* Chronic endocrine or metabolic diseases such as Diabetes.\n* Obesity (body mass index \\> 30 kg/m2).\n* Cases that will require intraoperative conversion of myomectomy to hysterectomy.'}, 'identificationModule': {'nctId': 'NCT02061657', 'briefTitle': 'Impact of Misoprostol on Blood Loss In Myomectomy Operations', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Phase 1 Study of Misoprostol in Reducing Intraoperative Bleeding in Myomectomy Operations', 'orgStudyIdInfo': {'id': 'AIN-1111-MM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Myomectomy, rectal Misoprostol', 'description': '25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.', 'interventionNames': ['Drug: Misoprostol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Myomectomy, Placebo', 'description': 'Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.', 'interventionNames': ['Drug: Placebo( for misoprostol)']}], 'interventions': [{'name': 'Misoprostol', 'type': 'DRUG', 'otherNames': ['Cytotec'], 'description': '25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation', 'armGroupLabels': ['Myomectomy, rectal Misoprostol']}, {'name': 'Placebo( for misoprostol)', 'type': 'DRUG', 'description': 'Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.', 'armGroupLabels': ['Myomectomy, Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Ain Shams University, Maternity Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Abd El Mgeed I. Abd El Mgeed, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams University'}, {'name': 'Mohamed S. Ali, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}, {'name': 'Mohamed A. Abdel-Hafeez, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}, {'name': 'Mina A. Yacoup, Fellow', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}, {'name': 'Ahmed M. Elnaggar, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DR', 'investigatorFullName': 'Dr.Ahmed Elnaggar', 'investigatorAffiliation': 'Ain Shams University'}}}}