Myoma Clinical Trial
Official title:
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
Verified date | February 2022 |
Source | Wael Elbanna Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Recruiting |
Enrollment | 162 |
Est. completion date | December 30, 2025 |
Est. primary completion date | August 30, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 16 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. Women aged 16-45 years 2. Appropriate medical status for open surgery (Largest Myoma size from 4 cm up to 20 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 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Wael El-Banna Clinic | Maadi | Cairo |
Lead Sponsor | Collaborator |
---|---|
Wael Elbanna Clinic |
Egypt,
Parker WH, Berek JS, Pritts EA, Olive D, Chalas E, Clarke-Pearson D. Regarding "Incidence of Occult Uterine Malignancy Following Vaginal Hysterectomy with Morcellation". J Minim Invasive Gynecol. 2018 Sep - Oct;25(6):1113. doi: 10.1016/j.jmig.2018.04.008. — View Citation
Song T, Kim MK, Kim ML, Jung YW, Yun BS, Seong SJ. Use of vasopressin vs epinephrine to reduce haemorrhage during myomectomy: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015 Dec;195:177-81. doi: 10.1016/j.ejogrb.2015.10.003. Epub 2015 Oct 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection in decreasing blood loss in women undergoing open myomectomy using haemostatic tourniquets. | To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection in decreasing blood loss in women undergoing open myomectomy using haemostatic tourniquets( measuring the amount of blood loss in mm ) | 12 hours | |
Secondary | 1. To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing open myomectomy using haemostatic tourniquets. | 1. To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing open myomectomy using haemostatic tourniquets. ( to evaluate the change in hemoglobin level between before and after the operation ) | 24 hours |
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