Topical Tranexamic Acid Plus Perivascular Vasopressin at the Time of Abdominal Myomectomy

Aswan University Hospital100 enrolled

Overview

In this study, the investigators will investigate the effectiveness of a topical tranexamic acid plus perivascular vasopressin compared with perivascular vasopressin alone for the reduction of blood loss at the time of myomectomy

Uterine fibroids are the most common female pelvic tumors occurring in about 15% to 30% of women in the reproductive age group. The major problem with myomectomy is excessive bleeding from the increased uterine blood supply. This can be life-threatening, resulting in blood transfusions, febrile morbidity, and potentially in loss of reproductive potential from a hysterectomy. Knowledge of the effectiveness of the interventions used to reduce blood loss during myomectomy is essential to enable evidence-based clinical decisions. Topical application of tranexamic acid(TA) provides a high drug concentration at the site of the wound and a low systemic concentration. Studies from cardiac and orthopedic surgery have shown an equal or superior effect of topical compared with intravenous TA on both bleeding and transfusion requirement. Topical treatment is cost-effective, and adverse effects or drug interactions have not been reported

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

100

Conditions

Myoma

Interventions

Topical TADRUG

A gauze soaked with 2 g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride0.9%

vasopressinDRUG

intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy

placebo to TAOTHER

(120 ml of sodium chloride 0.9%) used to compress the myoma bed for 5 min.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging * Age ≥ 18 years and ≤ 50 years * Pre-operative hemoglobin \>8 g/dl * Ability to understand and the willingness to sign a written informed consent. * Admissible medical/surgical history * Five or less symptomatic uterine myomas * All myomas are subserous or intramural. * Uterine size less than 24 weeks of pregnancy Exclusion Criteria: * Patients who have had a prior abdominal myomectomy * Post-menopausal women * Patients with known bleeding/clotting disorders * Patients with a history of gynecologic malignancy * Hypertension. * Cardiac and Pulmonary Diseases. * Obesity (body mass index \> 30 kg/m2). * History of allergic reactions attributed to misoprostol * Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Locations (1)

Aswan University Hospital

Aswān, Egypt

RECRUITING

Outcomes

Primary Outcomes

measure will be Mean amount of blood loss

measure will be Mean amount of blood loss by gravimetric methods

Time frame: intraoperative

Secondary Outcomes

the number of the patients need of blood transfusion

calculate the number of the patients need of blood transfusion

Time frame: 24 hours post delivery

Central Contacts

hany f allam, md

CONTACT

0102236052 hany.farouk@aswu.edu.eg

nahla w shady, md

CONTACT

01092440504 nahla.elsayed@aswu.edu.eg

Data from ClinicalTrials.gov

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