NCT05242783Completed
The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Using Haemostatic Tourniquets:
The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Using Haemostatic Tourniquets: Double Blinded Randomized Placebo-Controlled Trial
Source: ClinicalTrials.gov · Last updated 25 Jun 2024
Brief summary (registry, in English)
the study aims to evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing abdominal myomectomy. Moreover, to evaluate their efficacy in decreasing blood loss on operative time and to describe the injection sequelae for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 99 (actual)
- First submitted
- 9 Dec 2021
- Start date
- 1 Feb 2022
- Primary completion date
- 29 Mar 2024
- Lead sponsor
- Wael Elbanna Clinic
- NCT number
- NCT05242783
What you commit to
- Study type: Interventional
- Participants enrolled: 99
- From 1 Feb 2022 to the primary completion date, 29 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous myomectomy
- Concurrent anticoagulation therapy
- Any pelvic abnormalities requiring concomitant surgery
- Treatment with a GnRH agonist or ulipristal acetate within three months preceding surgery
Other illness
- History of bleeding disorders
- History of Uncontrolled ischaemic heart disease
Other
- Inability to understand and provide written informed consent.
Who the study is looking for
- Women aged 16-45 years
- Appropriate 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
Age in the registry: 16 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wael El Banna Clinic Coordinator of this site? Confirm its status | Maadi | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.