Clinical trial NCT06325501: Misoprostol Versus Oxytocin Infusion On Reducing Blood Loss During Abdominal Myomectomy
Official title: The Efficacy Of Misoprostol Versus Oxytocin Infusion On Reducing Blood Loss During Abdominal Myomectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Myoma;Uterus
Keywords: misoprostol
oxytocin
myomectomy
blood loss
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 56
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 criteria: 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.

Exclusion Criteria:

1. History of previous myomectomy
2. Allergy to Misoprostol, carbetocin, TXA, ethamsylate, Oxytocin, vasopressin, bupivacaine and epinephrine.
3. Hypertension.
4. Cardiac and Pulmonary diseases.
5. Patients who have bleeding disorders.
6. Patients on antiplatelets or anticoagulant before surgery.
7. Anemia (Hb \< 10g %).
8. Chronic endocrine or metabolic diseases such as Diabetes.
9. Renal and hepatic impairment.
10. Moderate and morbid Obesity (body mass index \> 35 kg/m2).
11. Cases that will require intraoperative conversion of myomectomy to hysterectomy.
12. Intracavitary, submucosal, pedunculated Subserosal and adnexal Myoma FIGO staging 0,1,2,7,8.
13. history of Gynecological infections (PID), history of abdominal infections e.g.: peritonitis, history of any abdominal or pelvic operation for non-obstetric cause.

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Primary outcomes:
measure: intra-operative blood loss
timeFrame: time of surgery
Secondary outcomes:
measure: blood transfusion
timeFrame: 24 hours
measure: post-operative Hb
timeFrame: 24 hours
measure: total surgery time
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine, Kasr el ainy hospital, Cairo university
Study officials:
affiliation: Cairo University
name: Tarek N Anees, MD
role: PRINCIPAL_INVESTIGATOR
References: