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Completed

NCT Number: NCT03930069

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

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 .

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Key information

Conditions

Submucous Leiomyoma of Uterus

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

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

Vasopressin

Drug

one ampoule of vasopressin was diluted to 50 ml of normal saline, and 10 ml (4 units of vasopressin) was withdrawn in a syringe.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 outcomes

  1. intraoperative bleeding

    Time frame: 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.

  2. operative time

    Time frame: 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

  3. haemoglobin and hematocrit deficit

    Time frame: 24 hours before myomectomy and 24 hour after myomectomy

    haemoglobin and hematocrit values before and after myomectomy

Secondary outcomes

  1. Degree of visual clarity

    Time frame: 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)

  2. Fluid deficit

    Time frame: 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

  3. time need for cervical dilatation

    Time frame: start from grasping the cervix till insertion of hysterescope

    time needed to dilate the cervix to admit the operative hysterescope

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 29, 2019
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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