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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 48
Healthy Volunteers: f
View:

• Inclusión Criteria:

• patients aged between 20 to 48 years old. BMI less than 35 kg/m2 symptomatic uterine myomas. Intramyometrial myoma staging from (3 to 6) according to FIGO staging through trans vaginal ultrasonography (TVUSG) or magnetic resonance imaging (MRI) according to FIGO classification.

• maximum diameter of the largest myoma is 15 cm. Uterine size between 14 to 28 weeks of pregnancy.

Locations
Other Locations
Egypt
faculty of medicine, Kasr el ainy hospital, Cairo university
RECRUITING
Cairo
Contact Information
Primary
waleed M El-khayat, MD
waleed_elkhyat@yahoo.com
01005263580
Backup
mona s Moghazy, MD
Moghazymona@yahoo.com
+447492650184
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2025-01-01
Participants
Target number of participants: 56
Treatments
Active_comparator: misoprostol
receiving a preoperative rectal dose of 800 ug of misoprostol half an hour before surgery
Active_comparator: oxytocin
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
Sponsors
Leads: Cairo University

This content was sourced from clinicaltrials.gov