Sublingual Misoprostol in Decreasing Blood Loss Prior to Myomectomy
Phase 3
Completed
- Conditions
- Blood Loss in Myomectomy
- Interventions
- Drug: placebo 400 sublingual
- Registration Number
- NCT02709564
- Lead Sponsor
- Assiut University
- Brief Summary
The aim of the study is to compare the effectiveness of sublingual administered prostaglandin E1 synthetic analogue (misoprostol) 400 microgram versus placebo before myomectomy to decrease blood loss during and after the operation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 80
Inclusion Criteria
- Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
- Age ≥ 18 years and ≤ 50 years
- Pre-operative hemoglobin >8 g/dl
- Ability to understand and the willingness to sign a written informed consent.
- Admissible medical/surgical history
- Five or less symptomatic uterine myomas
- All myomas are subserous or intramural.
- Uterine size less than 24 weeks pregnancy
Exclusion Criteria
- Patients who have had a prior abdominal myomectomy
- Post-menopausal women
- Patients with known bleeding/clotting disorders
- Patients with a history of gynecologic malignancy
- Hypertension.
- Cardiac and Pulmonary diseases.
- Obesity (body mass index > 30 kg/m2).
- History of allergic reactions attributed to misoprostol
- Cases that will require intraoperative conversion of myomectomy to hysterectomy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B Misoprostol 400 sublingual 400 microgram misoprostol Group A placebo 400 sublingual 400 mg placebo
- Primary Outcome Measures
Name Time Method Mean amount of intraoperative blood loss intraoperative
- Secondary Outcome Measures
Name Time Method Change of hemoglobin after surgery 24 hours
Trial Locations
- Locations (1)
Ahmed Abbas
🇪🇬Assiut, Cairo, Egypt