the Effectiveness of Preoperative Vaginal Dinoprostone in Reducing Blood Loss During Abdominal Myomectomy:a Randomized Controlled Trial
| Registry | NCT04080375 |
|---|---|
| Status | Unknown |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, prevention |
| Enrollment | 100 (Estimated) |
| Sponsor | Cairo University (Other) |
| Conditions | Myomectomy |
| Interventions | Dinoprostone 3 mg, placebo (Drug) |
| Dates | start 2019-09-10 (estimated), primary completion 2019-11-30 (estimated), completion 2019-12-10 (estimated), first posted 2019-09-06, last updated 2019-09-06 |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| dinoprostone 3 mg | Experimental | Drug: Dinoprostone 3 mg | patients will take 1 tablet of vaginal dinoprostone 1 hour before the surgery |
| placebo | Placebo comparator | Drug: placebo | patients will take 1 tablet of placebo 1 hour before the surgery |
Sex: Female, ages: 18 Years to 50 Years
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.