Comparing Terlipressin and Carbetocin for blood loss in laparoscopic myomectomy
The Effect of Intracapsular Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations: Double Blinded Randomized Placebo-Controlled Trial
This study is testing whether two different medications, Terlipressin and Carbetocin, can help reduce blood loss and improve hemoglobin levels in women having laparoscopic myomectomy for 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 | 1 site (Maadi) |
| Trial ID | NCT05170230 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of intracapsular injections of Terlipressin versus Carbetocin in reducing blood loss and improving hemoglobin levels in women undergoing laparoscopic myomectomy for myomas. It is a prospective, double-blinded, randomized, placebo-controlled study conducted at Wael ElBanna Clinic and the NRC site. Participants will be randomly assigned to one of three groups: Terlipressin, Carbetocin, or saline, and their medical records will be reviewed post-surgery to assess outcomes. The study aims to provide insights into the efficacy of these treatments in a surgical setting.
Who should consider this trial
Good fit: Ideal candidates are women aged 16-45 with myoma-related symptoms and appropriate medical status for laparoscopic surgery.
Not a fit: Patients with a history of bleeding disorders or those on anticoagulation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced blood loss for women undergoing myomectomy.
How similar studies have performed: While similar approaches have been explored, this specific comparison of Terlipressin and Carbetocin in this context is 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
Maadi
- 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.