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

Primary Purpose

Blood Loss in Myomectomy

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Misoprostol 400 sublingual
placebo 400 sublingual
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Loss in Myomectomy

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Ahmed Abbas

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

400 mg placebo

400 microgram misoprostol

Outcomes

Primary Outcome Measures

Mean amount of intraoperative blood loss

Secondary Outcome Measures

Change of hemoglobin after surgery

Full Information

First Posted
March 11, 2016
Last Updated
May 6, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02709564
Brief Title
Sublingual Misoprostol in Decreasing Blood Loss Prior to Myomectomy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss in Myomectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Placebo Comparator
Arm Description
400 mg placebo
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
400 microgram misoprostol
Intervention Type
Drug
Intervention Name(s)
Misoprostol 400 sublingual
Intervention Description
patients will take 2 tablets of sublingual misoprostol 400 microgram 3 hours and 1 hour before the surgery
Intervention Type
Drug
Intervention Name(s)
placebo 400 sublingual
Intervention Description
patients will take 2 tablets of sublingual placebo 400 microgram 1 hour before the surgery
Primary Outcome Measure Information:
Title
Mean amount of intraoperative blood loss
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Change of hemoglobin after surgery
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Ahmed Abbas
City
Assiut
State/Province
Cairo
ZIP/Postal Code
002
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Sublingual Misoprostol in Decreasing Blood Loss Prior to Myomectomy

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