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

Myoma Clinical Trial

Official title:

Topical Tranexamic Acid Plus Perivascular Vasopressin to Decrease Bleeding at the Time of Abdominal Myomectomy: A Double-blinded Randomized Placebo-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03880045
• Other study ID #: aswu/206/19
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: May 2019
• Source: Aswan University Hospital
• Contact: hany f allam, md
• Phone: 0102236052
• Email: hany.farouk[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myoma

Intervention

Drug:
• Topical TA
A gauze soaked with 2 g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride0.9%
• vasopressin
intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy

Other:
• placebo to TA
(120 ml of sodium chloride 0.9%) used to compress the myoma bed for 5 min.

Locations

Country	Name	City	State
Egypt	Aswan University Hospital	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure will be Mean amount of blood loss	measure will be Mean amount of blood loss by gravimetric methods	intraoperative
Secondary	the number of the patients need of blood transfusion	calculate the number of the patients need of blood transfusion	24 hours post delivery