Comparing Terlipressin and Carbitocin for Reducing Blood Loss in Myomectomy
The Effect of Intramyometrial Injection of Terlipressin Versus Intramyometrial Injection of Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations: Double Blinded Randomized Placebo-Controlled Trial
This study tests whether using Terlipressin or Carbitocin injections can help reduce blood loss during surgery for women with fibroids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 16 Years to 45 Years |
| Sex | Female |
| Sponsor | Wael Elbanna Clinic Academic / other |
| Locations | 2 sites (Cairo and 1 other locations) |
| Trial ID | NCT05154279 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of intramyometrial injections of Terlipressin versus Carbitocin in women undergoing laparoscopic myomectomy. It aims to assess their impact on hemoglobin levels and blood loss during the procedure. The study will also document any side effects associated with these injections. By focusing on women with symptomatic fibroids, the research seeks to improve surgical outcomes and recovery times.
Who should consider this trial
Good fit: Ideal candidates are women aged 16-45 with symptomatic fibroids and appropriate medical status for laparoscopic surgery.
Not a fit: Patients with a history of bleeding disorders or those requiring concurrent surgery for pelvic abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced blood loss and improved recovery for women undergoing myomectomy.
How similar studies have performed: While there is ongoing research in this area, the specific comparison of Terlipressin and Carbitocin for this purpose is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women aged 16-45 years 2. Appropriate medical status for laparoscopic surgery (largest myoma ≤15 cm) 3. Baseline hemoglobin ≥9 g/dl 4. No contra-indications to the use of glyopressin or carbitocin 5. Myoma-related symptoms, such as pelvic pressure or pain, menorrhagia, or infertility 6. Not pregnant at the time of presentation (i.e., negative urine pregnancy test or last menstrual period within the last 4 weeks) Exclusion Criteria: 1. Previous myomectomy 2. History of bleeding disorders 3. Concurrent anticoagulation therapy 4. History of Uncontrolled ischaemic heart disease 5. Any pelvic abnormalities requiring concomitant surgery 6. Treatment with a GnRH agonist or ulipristal acetate within three months preceding surgery 7. Inability to understand and provide written informed consent.
Where this trial is running
Cairo and 1 other locations
- National Research center — Cairo, Egypt (Recruiting)
- Wael El Banna Clinic — Maadi, Egypt (Recruiting)
Study contacts
- Study coordinator: Wael El Banna
- Email: waelelbanna@drwaelelbanna.com
- Phone: 01227760402
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.