Comparing Terlipressin and Carbetocin for reducing blood loss during myomectomy
The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets.
This study is testing whether injections of Terlipressin or Carbetocin can help reduce blood loss during surgery to remove fibroids in women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 16 Years to 40 Years |
| Sex | Female |
| Sponsor | Wael Elbanna Clinic Academic / other |
| Locations | 1 site (Maadi) |
| Trial ID | NCT05266534 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of intramyometrial injections of Terlipressin versus Carbetocin in reducing hemoglobin loss and blood loss during open myomectomy procedures without the use of haemostatic tourniquets. It is a prospective, double-blinded, randomized, placebo-controlled trial 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 to assess outcomes. The study aims to provide evidence that could influence clinical practices in gynecology.
Who should consider this trial
Good fit: Ideal candidates are women aged 16-45 with myoma-related symptoms and appropriate medical status for open surgery.
Not a fit: Patients with a history of bleeding disorders or those requiring concurrent surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of blood loss during myomectomy, enhancing patient safety and outcomes.
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 Criteri * Women aged 16-45 yearsAppropriate medical status for open surgery (Largest Myoma size from 4 cm up to 20 cm) * Baseline hemoglobin ≥9 g/dl * No contra-indications to the use of glyopressin or carbitocin * Myoma-related symptoms, such as pelvic pressure or pain,menorrhagia, or infertility * Not pregnant at the time of presentation (i.e., negative urine pregnancy test or last menstrual period within the last 4 weeks) Exclusion Criteria * Open myomectomy using mechanical tourniquet * Previous myomectomy * History of bleeding disorders * Concurrent anticoagulation therapy * History of Uncontrolled ischaemic heart disease * Any pelvic abnormalities requiring concomitant surgery * Treatment with a GnRH agonist or ulipristal acetate within three months preceding surgery * 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.