Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-26 @ 10:32 AM
Study NCT ID:
NCT05862428
Status:
COMPLETED
Last Update Posted:
2023-05-17
First Post:
2023-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rectal Misoprostol in Women Undergoing Total Abdominal Hysterectomy for Intraoperative Blood Loss Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The participants were devided in two groups. The experimental group received rectal misoprostol before surgery and the control group not received the drug'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-07', 'studyFirstSubmitDate': '2023-04-23', 'studyFirstSubmitQcDate': '2023-05-07', 'lastUpdatePostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative blood loss', 'timeFrame': '7 months', 'description': 'The intraoperative blood loss was defined as the blood at starting with a cut in the skin until the suture is closed. Its quantity was measure from blood pads and was record in millilitres. One gram of the blood was 1 ml.'}], 'secondaryOutcomes': [{'measure': 'hemoglobin difference', 'timeFrame': '7 months', 'description': 'The comparison of hemoglobin between the two groups.'}, {'measure': 'Blood transfusion', 'timeFrame': '7 months', 'description': 'Number of the participants between two groups that receive the blood component during or after the operation'}, {'measure': 'Number of participants that have side effects of misoprostol', 'timeFrame': '7 months', 'description': 'The comparison of frequencies of side effects of misoprostol between the two groups.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraoperative Blood Loss']}, 'descriptionModule': {'briefSummary': 'Comparing of the intraoperative blood loss between group rectal misoprostol group and control group', 'detailedDescription': 'This open-labeled randomized controlled trial was conducted at the Department of Obstetrics and Gynecology, Queen Savang Vadhana Memorial Hospital, Chonburi, Thailand, from February 2022 to September 2022, after approval of the Institution of Review Board of Queen Savang Vadhana Memorial Hospital (IRB No. 001/2565).\n\nFifty six (56) women with diagnosis of benign uterine disease who were scheduled to perform total abdominal hysterectomy with or without bilateral salpingo-oophorectomy between February 2022 to September 2022 at Queen Savang Vadhana Memorial Hospital were enrolled in this study.\n\nThe participants were randomly allocated into two groups, study and control group. The randomization list was kept in a sealed opaque envelope. Study group received two tablets of 200 mcg misoprostol; The drug was inserted rectally 1 hour before operation. Few drops of normal saline were used to dissolve tablets before insertion. Control group that did not receive the drug. The drug was administered by a nurse at Gynecologic ward. The primary outcome was intraoperative blood loss that recorded by measuring amount of blood on the surgical gauzes and swabs by standardized scales and another was recorded from blood in suction container. The secondary outcome was hemoglobin differentiation, rate of blood transfusion and adverse events of misoprostol usage.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFemale undergoing total abdominal hysterectomy (elective case) with\n\n* No history of bleeding tendency\n* No history of anticoagulant drug used within 7 days before surgery\n* No contraindications of Misoprostol drug used\n* No history of allergic to misoprostol\n\nExclusion Criteria:\n\n* Can not communicate with Thai language\n* Malignancy case\n* Emergency case'}, 'identificationModule': {'nctId': 'NCT05862428', 'briefTitle': 'Rectal Misoprostol in Women Undergoing Total Abdominal Hysterectomy for Intraoperative Blood Loss Reduction', 'organization': {'class': 'OTHER', 'fullName': 'Queen Savang Vadhana Memorial Hospital, Thailand'}, 'officialTitle': 'Rectal Misoprostol in Women Undergoing Total Abdominal Hysterectomy for Intraoperative Blood Loss Reduction', 'orgStudyIdInfo': {'id': '001/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rectal misoprostol', 'description': 'This group received misoprostol transrectally before surgery 1 hour', 'interventionNames': ['Drug: Rectal misoprostol']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'This group not received any drugs before surgery'}], 'interventions': [{'name': 'Rectal misoprostol', 'type': 'DRUG', 'description': 'This intervention group receive Misoprostol transrectally before undergoing total abdominal hysterectomy', 'armGroupLabels': ['Rectal misoprostol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20110', 'city': 'Chon Buri', 'state': 'Changwat Chon Buri', 'country': 'Thailand', 'facility': 'Yingdhanai Pannaraj', 'geoPoint': {'lat': 13.3622, 'lon': 100.98345}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Savang Vadhana Memorial Hospital, Thailand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}