Intravenous Tranexamic Acid Versus Vaginal Dinoprostone in Abdominal Myomectomy
Phase 4
- Conditions
- Myomectomy
- Interventions
- Registration Number
- NCT04357002
- Lead Sponsor
- Cairo University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 180
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intravenous tranexamic acid intravenous 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. vaginal dinoprostone vaginal dinoprostone 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 placebo vaginal 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
- Primary Outcome Measures
Name Time Method intraoperative blood loss one hour estimation of intraoperative blood loss in ml
- Secondary Outcome Measures
Name Time Method blood transfusion 24 hours need for intraoperative or postoperative blood transfusion