protocolSection identificationModule nctId: NCT06325501, orgStudyIdInfo id: AA-2024-1, briefTitle: Misoprostol Versus Oxytocin Infusion On Reducing Blood Loss During Abdominal Myomectomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Uterine leiomyomas, or fibroids, are common benign tumors among women, especially those over 35 years old. They can cause various issues, including heavy menstrual bleeding, anemia, pelvic pain, and pressure symptoms. Surgery is often necessary for symptomatic fibroids, with hysterectomy recommended for women over 40 and myomectomy for those wishing to preserve their uterus. Myomectomy can be performed using different surgical approaches but can be associated with significant morbidity, particularly major blood loss, especially in abdominal myomectomy, where up to 20% of women may require blood transfusion.Various interventions have been introduced to reduce bleeding during myomectomy, such as tourniquets, bupivacaine plus epinephrine infiltration, vasopressin injection, preoperative GnRH agonist administration, and preoperative ascorbic acid injection. However, these strategies may have complications, be ineffective, expensive, or require extra steps.Oxytocin, primarily secreted from the pituitary gland, is crucial for uterine contraction during labor and delivery, and is used to prevent postpartum uterine atony and bleeding. However, caution is needed in its use, especially in women with heart disease or hypovolemia.Misoprostol, a prostaglandin E1 analogue, can reduce bleeding during myomectomy by promoting myometrial contractions and reducing uterine artery blood flow. It can be administered via multiple routes, with rectal administration showing advantages in maintaining high plasma concentrations during surgery. Studies have investigated the effectiveness of single preoperative rectal doses of misoprostol versus preoperative oxytocin in reducing bleeding during abdominal myomectomy., conditionsModule conditions: Myoma;Uterus, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Misoprostol 200mcg Tab, interventions name: Oxytocin, outcomesModule primaryOutcomes measure: intra-operative blood loss, secondaryOutcomes measure: blood transfusion, secondaryOutcomes measure: post-operative Hb, secondaryOutcomes measure: total surgery time, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 48 Years, stdAges: ADULT, contactsLocationsModule locations facility: faculty of medicine, Kasr el ainy hospital, Cairo university, status: RECRUITING, city: Cairo, zip: 11562, country: Egypt, contacts name: Mohammad A Taymour, MD, role: CONTACT, phone: 01555761995, email: Mohammadtaymour@gmail.com, contacts name: Waleed M Elkhyat, role: CONTACT, phone: 01005135542, email: Waleed_elkhyat@yahoo.com, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False