Abdominal Myomectomy
Conditions
Brief summary
To investigate the effectiveness of carbetocin on reducing intraoperative blood loss during abdominal myomectomy
Interventions
DRUGcarbetocin 100 mcg
a 10 cm syringe containing 100 mcg carbetocin just before skin incision of myomectomy.
DRUGplacebo
a 10 cm syringe normal saline IV given just before skin incision of myomectomy.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* • Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging * Age ≥ 25 years and ≤ 50 years * Pre-operative hemoglobin \>10 g/dl * Ability to understand and the willingness to sign a written informed consent. * Admissible medical/surgical history * Five or less symptomatic uterine myomas * symptomatic stage 3 to 6 fibroids, according to FIGO staging
Exclusion criteria
* • Post-menopausal women * Patients with known bleeding/clotting disorders * Patients with a history of gynecologic malignancy * Hypertension. * Cardiac and Pulmonary diseases. * History of allergic reactions attributed to carbetocin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean amount of intraoperative blood loss | intraoperative | Mean amount of intraoperative blood loss in ml |
Countries
Egypt
Outcome results
None listed