Preoperative Vaginal Dinoprostone Prior to Abdominal Myomectomy
- Registration Number
- NCT04080375
- Lead Sponsor
- Cairo University
- Brief Summary
The aim of the study is to compare the effectiveness of vaginal dinoprostone 3 mg versus placebo before myomectomy to decrease blood loss during and after the operation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
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 dinoprostone 3 mg Dinoprostone 3 mg patients will take 1 tablet of vaginal dinoprostone 1 hour before the surgery placebo placebo patients will take 1 tablet of placebo 1 hour before the surgery
- Primary Outcome Measures
Name Time Method Mean amount of intraoperative blood loss intraoperative Mean amount of intraoperative blood loss in ml
- Secondary Outcome Measures
Name Time Method Change of hemoglobin after surgery 24 hours Change of hemoglobin(g/dl) after surgery