Safety of Tranexamic Acid in Reducing Blood Loss Myomectomy.

NCT ID: NCT04694677

Last Updated: 2021-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-10

Study Completion Date

2021-09-10

Brief Summary

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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

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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

Conditions

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Myoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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women receiving tranexamic acid

Group Type ACTIVE_COMPARATOR

women receiving tranexamic acid

Intervention Type DRUG

women receiving tranexamic acid during myomectomy

women receiving misoprostol

Group Type ACTIVE_COMPARATOR

women receiving misoprostol

Intervention Type DRUG

women receiving misoprostol in myomectomy

Interventions

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women receiving tranexamic acid

women receiving tranexamic acid during myomectomy

Intervention Type DRUG

women receiving misoprostol

women receiving misoprostol in myomectomy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* women with myomas

Exclusion Criteria

* with with malignant lesions
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Aljazeera Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mahmoud Alalfy

Role: STUDY_DIRECTOR

Algezeera hospitaland National Research Centre ,Egypt

Locations

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Algazeerah

Giza, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mahmoud Alalfy

Role: CONTACT

01002611058

Facility Contacts

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Mahmoud Alalfy, master

Role: primary

+201002611058

Ahmed Elgazzar, M.D

Role: backup

+201014005959

Other Identifiers

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Myomectomy

Identifier Type: -

Identifier Source: org_study_id

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