Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.

Efficacy of Transcervical Vasopressin Injection VersusVaginal Misoprostol During Hysteroscopic Myomectomy in Reducing Operative Blood Loss and Operation Time: A Randomized Trial.

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 .

Study Overview

• Status: Completed
• Conditions: Submucous Leiomyoma of Uterus
• Intervention / Treatment: Drug: Misoprostol; Drug: Vasopressin

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 .

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: misoprostol group; 20 cases received 400 microgram prostaglandin E1 analogue, misoprostol, (Misotac®, 200 microgram, by SIGMA pharmaceutical industries, Alexandria, Egypt), intra-vaginally, 2 hr before operation.	Drug: Misoprostol; prostaglandin E1 analogue vaginally inserted two hours before hystertsopic myomectomy to evaluate intraoperative blood loss and operative time needed for completion of myomectomy; Other Names: Misotac
Active Comparator: vasopressin group; 20 patients who had hysteroscopic guided intralesional vasopressin injection before hysteroscopic myomectomy	Drug: Vasopressin; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative bleeding	subjective assessment of bleeding by the surgeon.	start with the first resectoscope myoma cut till withdrawal of hysterscope through the cervix at the end of the procedure
operative time	time needed for completion of myomectomy procedure	start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end of the procedure
haemoglobin and hematocrit deficit	haemoglobin and hematocrit values before and after myomectomy	24 hours before myomectomy and 24 hour after myomectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	start with the first resectoscope myoma cut till the completion of myoma resection
Fluid deficit	calculation the fluid deficit between in flow volume and outflow volume	start with insertion of hysterscope through the cervix ends with withdrawal of hysterscopy through the cervix at the end pf the procedure
time need for cervical dilatation	time needed to dilate the cervix to admit the operative hysterescope	start from grasping the cervix till insertion of hysterescope

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2016
• Primary Completion (Actual): January 30, 2017
• Study Completion (Actual): March 15, 2017

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma; Physiological Effects of Drugs; Gastrointestinal Agents; Natriuretic Agents; Hemostatics; Coagulants; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Vasoconstrictor Agents; Antidiuretic Agents; Misoprostol; Vasopressins; Arginine Vasopressin
• Other Study ID Numbers: Hysterscopioc myomectomy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No