Sublingual Misoprostol in Decreasing Blood Loss Prior to Myomectomy (SL-MISO)

Assiut University

Status and phase: Completed; Phase 3

Conditions: Blood Loss in Myomectomy

Treatments: Drug: placebo 400 sublingual; Drug: Misoprostol 400 sublingual

Study type: Interventional

Funder types: Other

Identifiers

NCT02709564

misop 2

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Group A

Placebo Comparator group

Description:

400 mg placebo

Treatment:

Drug: placebo 400 sublingual

Group B

Active Comparator group

Description:

400 microgram misoprostol

Treatment:

Drug: Misoprostol 400 sublingual