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

Phase 2

Completed

• Conditions: Submucous Leiomyoma of Uterus
• Interventions: Drug: Vasopressin; Drug: Misoprostol

• Registration Number: NCT03930069
• Lead Sponsor: Zagazig University

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 .

Study Timeline

• Study Start: 2016-05-02
• Primary Completion: 2017-01-30
• Study Completion: 2017-03-15
• Status Verified: 2019-04
• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-04-25
• Last Update Submitted: 2019-04-25
• Study First Posted: 2019-04-29
• Last Update Posted: 2019-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vasopressin group	Vasopressin	20 patients who had hysteroscopic guided intralesional vasopressin injection before hysteroscopic myomectomy
misoprostol group	Misoprostol	20 cases received 400 microgram prostaglandin E1 analogue, misoprostol, (Misotac®, 200 microgram, by SIGMA pharmaceutical industries, Alexandria, Egypt), intra-vaginally, 2 hr before operation.

Primary Outcome Measures

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

Secondary Outcome Measures

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