Myomectomy
Conditions
Brief summary
the aim of the present study is to compare safety and efficacy of intravenous tranexamic acid versus IV carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trial
Interventions
DRUGintravenous tranexamic acid
The tranexamic acid (TXA) group will receive a single bolus IV injection of 15 mg/kg of TXA 20 minutes before surgical incision
DRUGintravenous carbetocin
The carbetocin group will receive a single bolus IV injection of 100 mcg of carbetocin 20 minutes before surgical incision
DRUGplacebo
the placebo group will be given a normal saline IV bolus 20 minutes before surgical incision
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* women with symptomatic fibroids candidate for abdominal myomectomy with staging of myoma from (3 to 6) according to FIGO staging
Exclusion criteria
* women with Myoma FIGO staging (1,2,7 and 8) candidate for laparoscopic or hysteroscopic myomectomy, women with allergy or contraindications to carbetocin or tranexamic acid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative blood loss | one hour | the intraoperative blood loss in ml will be estimated during the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| need for blood transfusion | 24 hours | need for intraoperative or postoperative blood transfusion |
Contacts
Primary ContactAHMED SAMY
Outcome results
None listed