Status:
COMPLETED
Evaluating Efficacy of Intravenous Carbetocin Versus Intramyometrial Injection of Adrenaline in Reducing Blood Loss
Lead Sponsor:
Egymedicalpedia
Conditions:
Uterine Fibroid
Eligibility:
FEMALE
25-50 years
Phase:
PHASE1
Brief Summary
Uterine fibroids, affecting 20-50% of all women ,and are benign tumors that arise from myometrial cells of the uterine smooth muscle tissue. Although most are asymptomatic, fibroids can often cause ab...
Detailed Description
Women with myomatous uteri have an increased number of blood supply which may cause excessive bleeding during myomectomy. The excessive bleeding may result in blood transfusions and prolonged hospital...
Eligibility Criteria
Inclusion
- Women aged 25-50 years old.
- Women who will undergo abdominal myomectomy because of symptomatic stage 3-6 fibroids, according to FIGO staging (Laughlin-Tommaso et al., 2017), with the number of myomas not exceeding five based on the preoperative ultrasonography (US).
Exclusion
- Women with previous myomectomy.
- Pregnant and postmenopausal women.
- Women with preoperative hemoglobin concentration \<10 g/dL,
- women who are candidate for and choosing vaginal or laparoscopic myomectomy.
- History of preoperative embolization or hormone therapy (GnRH analogues), cervical and broad ligament myoma, number of myomas more than five on preoperative US, myoma FIGO stages 1,2,7 and 8 (Munro et al., 2011)
- Patients with allergy or contraindications to carbetocin or epinephrine, such as coronary artery disease, asthma, epilepsy, migraine, kidney, and hepatic disease.
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2023
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT05986266
Start Date
February 1 2023
End Date
September 15 2023
Last Update
October 17 2023
Active Locations (1)
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1
Faculty of medicine, Cairo University
Cairo, Egypt