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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-02

Study Completion Date

2017-03-15

Brief Summary

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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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Detailed Description

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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 .

Conditions

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Submucous Leiomyoma of Uterus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

prostaglandin E1 analogue vaginally inserted two hours before hystertsopic myomectomy to evaluate intraoperative blood loss and operative time needed for completion of myomectomy

vasopressin group

20 patients who had hysteroscopic guided intralesional vasopressin injection before hysteroscopic myomectomy

Group Type ACTIVE_COMPARATOR

Vasopressin

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one ampoule of vasopressin was diluted to 50 ml of normal saline, and 10 ml (4 units of vasopressin) was withdrawn in a syringe.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

Interventions

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Misoprostol

prostaglandin E1 analogue vaginally inserted two hours before hystertsopic myomectomy to evaluate intraoperative blood loss and operative time needed for completion of myomectomy

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Misotac

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No