RecruitingPhase 3NCT06325501

Misoprostol Versus Oxytocin Infusion On Reducing Blood Loss During Abdominal Myomectomy

The Efficacy Of Misoprostol Versus Oxytocin Infusion On Reducing Blood Loss During Abdominal Myomectomy


Sponsor

Cairo University

Enrollment

56 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Uterine leiomyomas, or fibroids, are common benign tumors among women, especially those over 35 years old. They can cause various issues, including heavy menstrual bleeding, anemia, pelvic pain, and pressure symptoms. Surgery is often necessary for symptomatic fibroids, with hysterectomy recommended for women over 40 and myomectomy for those wishing to preserve their uterus. Myomectomy can be performed using different surgical approaches but can be associated with significant morbidity, particularly major blood loss, especially in abdominal myomectomy, where up to 20% of women may require blood transfusion. Various interventions have been introduced to reduce bleeding during myomectomy, such as tourniquets, bupivacaine plus epinephrine infiltration, vasopressin injection, preoperative GnRH agonist administration, and preoperative ascorbic acid injection. However, these strategies may have complications, be ineffective, expensive, or require extra steps. Oxytocin, primarily secreted from the pituitary gland, is crucial for uterine contraction during labor and delivery, and is used to prevent postpartum uterine atony and bleeding. However, caution is needed in its use, especially in women with heart disease or hypovolemia. Misoprostol, a prostaglandin E1 analogue, can reduce bleeding during myomectomy by promoting myometrial contractions and reducing uterine artery blood flow. It can be administered via multiple routes, with rectal administration showing advantages in maintaining high plasma concentrations during surgery. Studies have investigated the effectiveness of single preoperative rectal doses of misoprostol versus preoperative oxytocin in reducing bleeding during abdominal myomectomy.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 48 Years

Plain Language Summary

Simplified for easier understanding

This study compares two medications — misoprostol and oxytocin — used to reduce blood loss during surgery to remove uterine fibroids (a procedure called abdominal myomectomy). Heavy bleeding is a major risk during this surgery, and researchers want to find out which drug works better at keeping it under control. **You may be eligible if...** - You are between 20 and 48 years old - You have symptomatic uterine fibroids (causing pain, heavy periods, etc.) - Your BMI is below 35 - Your fibroids are classified at a certain stage (FIGO stage 3–6) - Your largest fibroid is no bigger than 15 cm - Your uterus is enlarged to the equivalent of a 14–28 week pregnancy **You may NOT be eligible if...** - You have had a previous fibroid removal surgery (myomectomy) - You are allergic to misoprostol, oxytocin, or related medications used in the procedure - You have high blood pressure, heart or lung disease - You have a bleeding disorder or are taking blood thinners - You are anemic (hemoglobin below 10 g/dL) - You have chronic conditions like diabetes or other metabolic diseases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMisoprostol 200mcg Tab

receiving a preoperative rectal dose of 800 ug of misoprostol half an hour before surgery

DRUGOxytocin

after the induction of general anaesthesia (GA), an infusion of 40 IU oxytocin in 500 ml normal saline was started at the rate of 250 ml/hour


Locations(1)

faculty of medicine, Kasr el ainy hospital, Cairo university

Cairo, Egypt

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NCT06325501


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