Back to resultsVasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.
Primary Purpose
Submucous Leiomyoma of Uterus
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Misoprostol
Vasopressin
Sponsored by
About this trial
This is an interventional treatment trial for Submucous Leiomyoma of Uterus
Eligibility Criteria
Inclusion Criteria:
- symptomatic women presented with bleeding or infertility and scheduled for hysterscopic myomectomy
- grade 0 and grade 1 submucous myomas
- less than 5 centimeters in diameter
Exclusion Criteria:
- Patients with grade 2 submucous myoma or more
- patients with submucous myomas larger than 5 cm in diameter
- postmenopausal women
- patients received GnRh analogue in last 6 months
- patients with anticoagulant therapy
- patients with endometrial premalignant or malignant pathologies
- patients with cardiovascular diseases, asthma or impaired kidney functions
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
misoprostol group
vasopressin group
Arm Description
20 cases received 400 microgram prostaglandin E1 analogue, misoprostol, (Misotac®, 200 microgram, by SIGMA pharmaceutical industries, Alexandria, Egypt), intra-vaginally, 2 hr before operation.
20 patients who had hysteroscopic guided intralesional vasopressin injection before hysteroscopic myomectomy
Outcomes
Primary Outcome Measures
intraoperative bleeding
subjective assessment of bleeding by the surgeon.
operative time
time needed for completion of myomectomy procedure
haemoglobin and hematocrit deficit
haemoglobin and hematocrit values before and after myomectomy
Secondary Outcome Measures
Degree of visual clarity
visual analogue scale straight horizontal line of fixed length, usually 100 mm and the ends are defined as the extreme limits of the parameter)
Fluid deficit
calculation the fluid deficit between in flow volume and outflow volume
time need for cervical dilatation
time needed to dilate the cervix to admit the operative hysterescope
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03930069
Brief Title
Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.
Official Title
Efficacy of Transcervical Vasopressin Injection VersusVaginal Misoprostol During Hysteroscopic Myomectomy in Reducing Operative Blood Loss and Operation Time: A Randomized Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 2, 2016 (Actual)
Primary Completion Date
January 30, 2017 (Actual)
Study Completion Date
March 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A prospective randomized study designed to compare the efficacy of transcervical vasopressin injection versus vaginal misoprostol in reducing intra -operative blood loss during hysteroscopic mymectomy .
Detailed Description
This was a prospective, randomized, study on forty women with symptomatic submucous myoma presented mostly with bleeding and/or infertility scheduled for hysteroscopic myomectomy were randomized to groups (group A) 20 patients transcervical intramyoma vasopressin injection and (group B) 20patients with vaginal misoprostol is used .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Submucous Leiomyoma of Uterus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
misoprostol group
Arm Type
Active Comparator
Arm Description
20 cases received 400 microgram prostaglandin E1 analogue, misoprostol, (Misotac®, 200 microgram, by SIGMA pharmaceutical industries, Alexandria, Egypt), intra-vaginally, 2 hr before operation.
Arm Title
vasopressin group
Arm Type
Active Comparator
Arm Description
20 patients who had hysteroscopic guided intralesional vasopressin injection before hysteroscopic myomectomy
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Misotac
Intervention Description
prostaglandin E1 analogue vaginally inserted two hours before hystertsopic myomectomy to evaluate intraoperative blood loss and operative time needed for completion of myomectomy
Intervention Type
Drug
Intervention Name(s)
Vasopressin
Intervention Description
one ampoule of vasopressin was diluted to 50 ml of normal saline, and 10 ml (4 units of vasopressin) was withdrawn in a syringe. Needle was inserted through the working channel of the hysteroscope until its tip was seen. The needle tip was pointed to the site of injection under hysteroscopic guidance during the whole injection technique. Aspiration was done first to avoid intravascular injection of vasopressin. The diluted solution was injected into the surface, especially to parts with dilated vasculature till they blanch.
Primary Outcome Measure Information:
Title
intraoperative bleeding
Description
subjective assessment of bleeding by the surgeon.
Time Frame
start with the first resectoscope myoma cut till withdrawal of hysterscope through the cervix at the end of the procedure
Title
operative time
Description
time needed for completion of myomectomy procedure
Time Frame
start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end of the procedure
Title
haemoglobin and hematocrit deficit
Description
haemoglobin and hematocrit values before and after myomectomy
Time Frame
24 hours before myomectomy and 24 hour after myomectomy
Secondary Outcome Measure Information:
Title
Degree of visual clarity
Description
visual analogue scale straight horizontal line of fixed length, usually 100 mm and the ends are defined as the extreme limits of the parameter)
Time Frame
start with the first resectoscope myoma cut till the completion of myoma resection
Title
Fluid deficit
Description
calculation the fluid deficit between in flow volume and outflow volume
Time Frame
start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end pf the procedure
Title
time need for cervical dilatation
Description
time needed to dilate the cervix to admit the operative hysterescope
Time Frame
start from grasping the cervix till insertion of hysterescope
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Yes: Eligibility is based on gender, As the subject of the study is hysterscopic myomectomy so the the clinical trial is based on female gender
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
symptomatic women presented with bleeding or infertility and scheduled for hysterscopic myomectomy
grade 0 and grade 1 submucous myomas
less than 5 centimeters in diameter
Exclusion Criteria:
Patients with grade 2 submucous myoma or more
patients with submucous myomas larger than 5 cm in diameter
postmenopausal women
patients received GnRh analogue in last 6 months
patients with anticoagulant therapy
patients with endometrial premalignant or malignant pathologies
patients with cardiovascular diseases, asthma or impaired kidney functions
12. IPD Sharing Statement
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Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.
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