Safety of Tranexamic Acid in Reducing Blood Loss Myomectomy.
Primary Purpose
Myoma
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
women receiving tranexamic acid
women receiving misoprostol
Sponsored by
About this trial
This is an interventional other trial for Myoma
Eligibility Criteria
Inclusion Criteria:
- women with myomas
Exclusion Criteria:
- with with malignant lesions
Sites / Locations
- Algazeerah
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
women receiving tranexamic acid
women receiving misoprostol
Arm Description
Outcomes
Primary Outcome Measures
the number of women who will have less blood loss
how many women will have less blood loss
Secondary Outcome Measures
Full Information
NCT ID
NCT04694677
First Posted
January 2, 2021
Last Updated
January 2, 2021
Sponsor
Aljazeera Hospital
Collaborators
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT04694677
Brief Title
Safety of Tranexamic Acid in Reducing Blood Loss Myomectomy.
Official Title
Safety of Tranexamic Acid Versus Misoprostol in Reducing Blood Loss in Myomectomy.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2021 (Anticipated)
Primary Completion Date
August 15, 2021 (Anticipated)
Study Completion Date
September 10, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aljazeera Hospital
Collaborators
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Uterine leiomyomas (fibroids) are the most common benign tumors among women . Fibroids are found in approximately 15% to 30% of women in the reproductive age group
Detailed Description
Although most of them are asymptomatic, 20-50% of fibroids may cause problems such as heavy menstrual bleeding, anemia, pelvic pain, pressure symptoms from extrinsic compression of the colorectal and urinary tract, infertility, and recurrent pregnancy losses, where surgical intervention is often indicated
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myoma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
women receiving tranexamic acid
Arm Type
Active Comparator
Arm Title
women receiving misoprostol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
women receiving tranexamic acid
Intervention Description
women receiving tranexamic acid during myomectomy
Intervention Type
Drug
Intervention Name(s)
women receiving misoprostol
Intervention Description
women receiving misoprostol in myomectomy
Primary Outcome Measure Information:
Title
the number of women who will have less blood loss
Description
how many women will have less blood loss
Time Frame
48 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
women with myomas
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
women with myomas
Exclusion Criteria:
with with malignant lesions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Alalfy
Phone
01002611058
Email
mahmoudalalfy@ymail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy
Organizational Affiliation
Algezeera hospitaland National Research Centre ,Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Algazeerah
City
Giza
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master
Phone
+201002611058
Email
mahmoudalalfy@ymail.com
First Name & Middle Initial & Last Name & Degree
Ahmed Elgazzar, M.D
Phone
+201014005959
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master
12. IPD Sharing Statement
Learn more about this trial
Safety of Tranexamic Acid in Reducing Blood Loss Myomectomy.
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