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

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Loss in Myomectomy
• Intervention / Treatment: Drug: placebo 400 sublingual; Drug: Misoprostol 400 sublingual

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Assiut, Cairo, Egypt, 002
      • Ahmed Abbas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group A; 400 mg placebo	Drug: placebo 400 sublingual; patients will take 2 tablets of sublingual placebo 400 microgram 1 hour before the surgery
Active Comparator: Group B; 400 microgram misoprostol	Drug: Misoprostol 400 sublingual; patients will take 2 tablets of sublingual misoprostol 400 microgram 3 hours and 1 hour before the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean amount of intraoperative blood loss	intraoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Change of hemoglobin after surgery	24 hours

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: March 11, 2016
• First Submitted That Met QC Criteria: March 11, 2016
• First Posted (Estimate): March 16, 2016

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: misop 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO