Comparing Misoprostol and Oxytocin to Reduce Blood Loss During Myomectomy
The Efficacy Of Misoprostol Versus Oxytocin Infusion On Reducing Blood Loss During Abdominal Myomectomy
This study tests whether Misoprostol or Oxytocin can help reduce blood loss during surgery for women with painful uterine fibroids.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 20 Years to 48 Years |
| Sex | Female |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06325501 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Misoprostol versus Oxytocin infusion in reducing blood loss during abdominal myomectomy for women with symptomatic uterine fibroids. The study focuses on patients aged 20 to 48 years with specific criteria regarding the size and staging of their myomas. By comparing these two interventions, the trial aims to identify a safer and more effective method to minimize the risk of significant blood loss during surgery. The study is conducted at Cairo University, utilizing a randomized approach to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 20 to 48 with symptomatic uterine myomas and a BMI less than 35 kg/m2.
Not a fit: Patients with a history of previous myomectomy, certain medical conditions, or those requiring conversion to hysterectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced need for blood transfusions in women undergoing myomectomy.
How similar studies have performed: Previous studies have explored various interventions to reduce blood loss during myomectomy, but the specific comparison of Misoprostol and Oxytocin in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
-
Where this trial is running
Cairo
- faculty of medicine, Kasr el ainy hospital, Cairo university — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Tarek N Anees, MD — Cairo University
- Study coordinator: waleed M El-khayat, MD
- Email: waleed_elkhyat@yahoo.com
- Phone: 01005263580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.