Clinical trial · Interventional
Evaluating Efficacy of Intravenous Carbetocin Versus Intramyometrial Injection of Adrenaline in Reducing Blood Loss
Evaluating Efficacy of Intravenous Carbetocin Versus Intramyometrial Injection of Adrenaline in Reducing Blood Loss During Abdominal Myomectomy: A Randomized Controlled Trial
NCT05986266CI-TRIAL-00070525completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carbetocin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A
- description
- 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.
- interventionNames
- Drug: Carbetocin
- type
- EXPERIMENTAL
- label
- Group B
- description
- 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
- interventionNames
- Drug: Carbetocin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Months
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.