Sublingual Misoprostol in Decreasing Blood Loss Prior to Myomectomy

Blood Loss in Myomectomy Clinical Trial

— SL-MISO  

Official title:

Single Dose Versus Two Doses of Sublingual Misoprostol in Decreasing Blood Loss Prior to Abdominal Myomectomy: A Randomized Double-blinded Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02709564
• Other study ID #: misop 2
• Status: Completed
• Phase: Phase 3
• Start date: December 2016
• Est. completion date: February 2020

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Loss in Myomectomy
• Hemorrhage

Intervention

Drug:
• Misoprostol 400 sublingual
patients will take 2 tablets of sublingual misoprostol 400 microgram 3 hours and 1 hour before the surgery
• placebo 400 sublingual
patients will take 2 tablets of sublingual placebo 400 microgram 1 hour before the surgery

Locations

Country	Name	City	State
Egypt	Ahmed Abbas	Assiut	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean amount of intraoperative blood loss		intraoperative
Secondary	Change of hemoglobin after surgery		24 hours