Safety of Tranexamic Acid in Reducing Blood Loss Myomectomy.

• Sponsor: Aljazeera Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04694677
• Collaborator: Cairo University (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 7.5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Myoma	Drug: women receiving tranexamic acid; Drug: women receiving misoprostol	N/A

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Safety of Tranexamic Acid Versus Misoprostol in Reducing Blood Loss in Myomectomy.
• Anticipated Study Start Date: Jan 10, 2021
• Anticipated Primary Completion Date: Aug 15, 2021
• Anticipated Study Completion Date: Sep 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: women receiving tranexamic acid	Drug: women receiving tranexamic acid; women receiving tranexamic acid during myomectomy
Active Comparator: women receiving misoprostol	Drug: women receiving misoprostol; women receiving misoprostol in myomectomy

Outcome Measures

Primary Outcome Measures

1. the number of women who will have less blood loss [48 hours]

   how many women will have less blood loss

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• women with myomas

Exclusion Criteria:

• with with malignant lesions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Algazeerah	Giza		Egypt

Sponsors and Collaborators

• Aljazeera Hospital
• Cairo University

Investigators

• Study Director: Mahmoud Alalfy, Algezeera hospitaland National Research Centre ,Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aljazeera Hospital
• ClinicalTrials.gov Identifier: NCT04694677
• Other Study ID Numbers: Myomectomy
• First Posted: Jan 5, 2021
• Last Update Posted: Jan 5, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemorrhage; Misoprostol; Tranexamic Acid

Study Results

No Results Posted as of Jan 5, 2021