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

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ClinicalTrials.gov Identifier: NCT03930069
Recruitment Status : Completed
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Hossam mohamed, 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 .

Condition or disease Intervention/treatment Phase
Submucous Leiomyoma of Uterus Drug: Misoprostol Drug: Vasopressin Phase 2 Phase 3

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 .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Transcervical Vasopressin Injection VersusVaginal Misoprostol During Hysteroscopic Myomectomy in Reducing Operative Blood Loss and Operation Time: A Randomized Trial.
Actual Study Start Date : May 2, 2016
Actual Primary Completion Date : January 30, 2017
Actual Study Completion Date : March 15, 2017

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   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
Accepts Healthy Volunteers:   No
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

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Responsible Party: Hossam mohamed, clinical investigator, Zagazig University
ClinicalTrials.gov Identifier: NCT03930069     History of Changes
Other Study ID Numbers: Hysterscopioc myomectomy
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leiomyoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Vasopressins
Arginine Vasopressin
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents