Myomectomy
Conditions
Brief summary
the aim of the present study is to evaluate safety and efficacy of intravenous tranexamic acid versus vaginal dinoprostone in reducing intraoperative blood loss during abdominal myomectomy
Interventions
DRUGintravenous tranexamic acid
patients will be given a single bolus IV injection of 15 mg/kg of tranexamic acid (TXA) 20 minutes before surgical incision plus one vaginal placebo tablet 60 minutes before skin incision.
patients will be given one vaginal dinoprostone tablet (3mg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision
DRUGvaginal placebo
patients will be given one vaginal placebo tablet 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* symptomatic fibroids candidate for abdominal myomectomy
Exclusion criteria
* patients candidate for laparoscopic or hysteroscopic myomectomy or had contraindications or allergy to dinoprostone or tranexamic acid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative blood loss | one hour | estimation of intraoperative blood loss in ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood transfusion | 24 hours | need for intraoperative or postoperative blood transfusion |
Contacts
Primary ContactAHMED SAMY
Outcome results
None listed