DRUG
Terlipressin
the efficacy of intramyometrial Terlipressin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy
Status
Recruiting
Phase
Not applicable
Enrollment
162
Locations
1
Results
Not posted
Publications
1
Study summary
For gynecologists, reaching a conclusion about the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy that would influence the clinical decision and best practice. Besides enriching the clinical evidence in open myomectomy without using haemostatic tourniquets. For society, our conclusion and recommendation shall maximize the benefits and managing the benefits of the technique used. Moreover, providing more information for women undergoing open myomectomy without using haemostatic tourniquets.
This study is a prospective, comparative, double-blinded randomized placebo-controlled trial and multi-center study that will be conducted at Wael ElBanna Clinic and the NRC site. The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants. Data will be pooled and presented in aggregate, without the identification of individual subjects. The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms: * Arm 1: intramyometrial Terlipressin injection in women undergoing open myomectomy procedure without using haemostatic tourniquets * Arm 2: intramyometrial Carbetocin injection in women undergoing open myomectomy procedure without using haemostatic tourniquets * Arm 3: intramyometrial saline injection in women undergoing open myomectomy procedure without using haemostatic tourniquets Subjects who meet diagnostic requirements as listed in the inclusion and exclusion criteria will be included in the study. Women will be randomized to one of the three arms using a computergenerated randomization table with a 1:1:1 group allocation
Interventions
DRUG
the efficacy of intramyometrial Terlipressin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy
DRUG
the efficacy of intramyometrial carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy
DRUG
the efficacy of intramyometrial saline injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy
Timeline
First posted
Mar 4, 2022
Study start
Dec 30, 2021
Primary completion
Jun 30, 2024
Study completion
Dec 30, 2026
Results posted
Not reported
Registry updated
Mar 4, 2022
Outcomes
To measure the volume of intraoperative blood loss in each group without using haemostatic tourniquets
Time frame · 12 hours
the volume of intraoperative blood loss in ml myomectomy without using haemostatic tourniquets
To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets
Time frame · 24 hours
To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets
To measure the operative time in each group without using haemostatic tourniquets
Time frame · 24 hours
To measure the operative time in each group without using haemostatic tourniquets
to assess the measure the severity of pain using VAS score
Time frame · 24 hours
post operative pain VAS score
Eligibility
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
Study locations
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Wael El Banna Clinic
Maadi, Egypt
Publications
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