Sublingual Misoprostol in Decreasing Blood Loss Prior to Myomectomy

• Status: Completed
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: Female

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.

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

Details

• Lead Sponsor: Assiut University
• Treatments: Misoprostol

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.