Preoperative Vaginal Dinoprostone Prior to Abdominal Myomectomy

• Status: Unknown status
• Trial end date: 2019-12-10
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Dinoprostone

Criteria

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.