Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-26 @ 1:01 AM
Study NCT ID:
NCT05266534
Status:
RECRUITING
Last Update Posted:
2022-03-04
First Post:
2021-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets
Sponsor:
Wael Elbanna Clinic
Organization:
Study Overview
Official Title:
The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets.
Status:
RECRUITING
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
myomectomy
Brief 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.
Detailed Description:
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
* 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: