Impact of Misoprostol on Blood Loss In Myomectomy Operations

Phase 3CompletedNCT02061657

Ain Shams University50 enrolled

Overview

The aim of this research work is to assess the effect of using single preoperative dose of rectal misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications

This study is a randomized, double-blind, controlled study that will be conducted in Ain Shams University Maternity Hospital. A total of 50 women scheduled to undergo myomectomy for symptomatic uterine myoma will be included in this study after taking their consent for this clinical trial after full explanation of the trial. The total of 50 included patients will be divided into two groups: Group A (Study group;): will Include 25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.Group B (Control group): will Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Leiomyoma

Interventions

MisoprostolDRUG

25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation

Placebo( for misoprostol)DRUG

Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Premenopausal patients aged between 35 to 50 years old. * Five or less symptomatic uterine myomas . * Maximum diameter of the largest myoma is 6 cm . * All myomas are subserous or intramural. * Uterine size less than 24 weeks pregnancy Exclusion Criteria: * History of previous surgery. * Allergy to Misoprostol. * Hypertension. * Cardiac and Pulmonary diseases. * Patients who have bleeding disorders. * Anemia (Hb \< 10g %). * Chronic endocrine or metabolic diseases such as Diabetes. * Obesity (body mass index \> 30 kg/m2). * Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Locations (1)

Ain Shams University, Maternity Hospital

Cairo, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

intraoperative blood loss

Time frame: time from peritoneum opening till its closure around (1 Hour)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.