Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-02-25 @ 9:50 PM
Study NCT ID:
NCT03930069
Status:
COMPLETED
Last Update Posted:
2019-04-29
First Post:
2019-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}, {'id': 'D014667', 'term': 'Vasopressins'}], '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'}, {'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-25', 'studyFirstSubmitDate': '2019-04-23', 'studyFirstSubmitQcDate': '2019-04-25', 'lastUpdatePostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraoperative bleeding', 'timeFrame': 'start with the first resectoscope myoma cut till withdrawal of hysterscope through the cervix at the end of the procedure', 'description': 'subjective assessment of bleeding by the surgeon.'}, {'measure': 'operative time', 'timeFrame': 'start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end of the procedure', 'description': 'time needed for completion of myomectomy procedure'}, {'measure': 'haemoglobin and hematocrit deficit', 'timeFrame': '24 hours before myomectomy and 24 hour after myomectomy', 'description': 'haemoglobin and hematocrit values before and after myomectomy'}], 'secondaryOutcomes': [{'measure': 'Degree of visual clarity', 'timeFrame': 'start with the first resectoscope myoma cut till the completion of myoma resection', 'description': 'visual analogue scale straight horizontal line of fixed length, usually 100 mm and the ends are defined as the extreme limits of the parameter)'}, {'measure': 'Fluid deficit', 'timeFrame': 'start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end pf the procedure', 'description': 'calculation the fluid deficit between in flow volume and outflow volume'}, {'measure': 'time need for cervical dilatation', 'timeFrame': 'start from grasping the cervix till insertion of hysterescope', 'description': 'time needed to dilate the cervix to admit the operative hysterescope'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Submucous Leiomyoma of Uterus']}, 'descriptionModule': {'briefSummary': 'A prospective randomized study designed to compare the efficacy of transcervical vasopressin injection versus vaginal misoprostol in reducing intra -operative blood loss during hysteroscopic mymectomy .', 'detailedDescription': 'This was a prospective, randomized, study on forty women with symptomatic submucous myoma presented mostly with bleeding and/or infertility scheduled for hysteroscopic myomectomy were randomized to groups (group A) 20 patients transcervical intramyoma vasopressin injection and (group B) 20patients with vaginal misoprostol is used .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Yes: Eligibility is based on gender, As the subject of the study is hysterscopic myomectomy so the the clinical trial is based on female gender', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptomatic women presented with bleeding or infertility and scheduled for hysterscopic myomectomy\n* grade 0 and grade 1 submucous myomas\n* less than 5 centimeters in diameter\n\nExclusion Criteria:\n\n* Patients with grade 2 submucous myoma or more\n* patients with submucous myomas larger than 5 cm in diameter\n* postmenopausal women\n* patients received GnRh analogue in last 6 months\n* patients with anticoagulant therapy\n* patients with endometrial premalignant or malignant pathologies\n* patients with cardiovascular diseases, asthma or impaired kidney functions'}, 'identificationModule': {'nctId': 'NCT03930069', 'briefTitle': 'Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Efficacy of Transcervical Vasopressin Injection VersusVaginal Misoprostol During Hysteroscopic Myomectomy in Reducing Operative Blood Loss and Operation Time: A Randomized Trial.', 'orgStudyIdInfo': {'id': 'Hysterscopioc myomectomy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'misoprostol group', 'description': '20 cases received 400 microgram prostaglandin E1 analogue, misoprostol, (Misotac®, 200 microgram, by SIGMA pharmaceutical industries, Alexandria, Egypt), intra-vaginally, 2 hr before operation.', 'interventionNames': ['Drug: Misoprostol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'vasopressin group', 'description': '20 patients who had hysteroscopic guided intralesional vasopressin injection before hysteroscopic myomectomy', 'interventionNames': ['Drug: Vasopressin']}], 'interventions': [{'name': 'Misoprostol', 'type': 'DRUG', 'otherNames': ['Misotac'], 'description': 'prostaglandin E1 analogue vaginally inserted two hours before hystertsopic myomectomy to evaluate intraoperative blood loss and operative time needed for completion of myomectomy', 'armGroupLabels': ['misoprostol group']}, {'name': 'Vasopressin', 'type': 'DRUG', 'description': 'one ampoule of vasopressin was diluted to 50 ml of normal saline, and 10 ml (4 units of vasopressin) was withdrawn in a syringe. Needle was inserted through the working channel of the hysteroscope until its tip was seen. The needle tip was pointed to the site of injection under hysteroscopic guidance during the whole injection technique. Aspiration was done first to avoid intravascular injection of vasopressin. The diluted solution was injected into the surface, especially to parts with dilated vasculature till they blanch.', 'armGroupLabels': ['vasopressin group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical investigator', 'investigatorFullName': 'Hossam mohamed', 'investigatorAffiliation': 'Zagazig University'}}}}