Evaluating Efficacy of Intravenous Carbetocin Versus Intramyometrial Injection of Adrenaline in Reducing Blood Loss

NCT05986266 | Completed Phase 1 DMC

• 1 other identifier: Micheal Hany Monir
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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 abnormal uterine bleeding, iron deficiency anemia, pelvic pressure symptoms and pain

Conditions

Uterine Fibroid

Outcome Measures

Primary Outcomes (1)

• Intraoperative and Post operative bleeding(defined as blood loss ≥500 cc)

  Compare efficacy of intravenous carbetocin to intramyometrial injection of adrenaline in reducing intraoperative blood loss during abdominal myomectomy Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level pre and post operatively.

  First 2 hours after abdominal myomectomy

Secondary Outcomes (1)

• Side Effects Of the used drugs in the operation

  First 24 hours after abdominal myomectomy

Study Arms (2)

Group A

ACTIVE COMPARATOR

patients will receive carbetocin, The optimal carbetocin dose(IV or IM) is 100 mcg. The carbetocin group will receive 100 mcg IV carbetocin (Pabal; Ferring Pharmaceuticals) in 10 mL saline solution. The anesthesiologists will administrate carbetocin slowly over 5 minutes (at a rate of 2 mL/min) to maintain hemodynamic stability.

Drug: Carbetocin

Group B

EXPERIMENTAL

patients will receive adrenalin, infiltration of the serosa and/or myometrium overlying the leiomyoma before uterine incision with a solution composed of 50 ml Bupivacaine HCL 0.25% and 0.5 mg of adrenaline.The anesthesiologist will be informed prior to the injection of the solution to ensure proper monitoring. The solution will be prepared just before the procedure. Before each infiltration, aspiration will be performed to avoid intravascular injection

Drug: Carbetocin

Interventions

Carbetocin DRUG

To compare efficacy of intravenous carbetocin to intramyometrial injection of adrenaline in decreasing intraoperative blood loss and need for blood transfusion during abdominal myomectomy.

Also known as: Adrenaline

Group A; Group B

Eligibility Criteria

• Age: 25 Months - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Faculty of medicine, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Leiomyoma

Interventions

carbetocin; Epinephrine

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Waleed Saber, Professor

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 14, 2023
• Study Start: February 1, 2023
• Primary Completion: August 30, 2023
• Study Completion: September 15, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10

Locations

EG (1)