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

Submucous Leiomyoma of Uterus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930069
• Other study ID #: Hysterscopioc myomectomy
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 2, 2016
• Est. completion date: March 15, 2017

Study information

• Verified date: April 2019
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 15, 2017
• Est. primary completion date: January 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Submucous Leiomyoma of Uterus
• Uterine Neoplasms

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	haemoglobin and hematocrit deficit	haemoglobin and hematocrit values before and after myomectomy	24 hours before myomectomy and 24 hour after myomectomy
Secondary	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
Secondary	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
Secondary	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