Myomectomy
Conditions
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.
Interventions
the patient will take one vaginal tablet of 3 mg dinoprostone 1 hour before surgery
DRUGplacebo
the patient will take one vaginal tablet of placebo 1 hour before surgery
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean amount of intraoperative blood loss | intraoperative | Mean amount of intraoperative blood loss in ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of hemoglobin after surgery | 24 hours | Change of hemoglobin(g/dl) after surgery |
Contacts
Primary ContactAHMED SAMY
Outcome results
None listed