Intravenous Oxytocin Versus Tranexamic Acid in Reducing Blood Loss During Abdominal Myomectomy.

NCT03892668 | Completed Phase 4

• 1 other identifier: myomectomy
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Uterine leiomyomas (fibroids) are the most common benign tumors among women. Fibroids are found in approximately 20% of women over 35 years of age. In 20-50% of patients, fibroids may cause problems such as heavy menstrual bleeding, anemia, pelvic pain, pressure symptoms from extrinsic compression of the colorectal and urinary tract. Surgery is indicated for symptomatic uterine leiomyomas; hysterectomy for women who have completed childbearing (women \> 40 years old), and myomectomy for women \<40 years old who wish to preserve uterus and fertility.

Conditions

Myomectomy

Outcome Measures

Primary Outcomes (1)

• Intraoperative Blood loss

  The total volume of intraoperative blood loss was estimated by measuring the amount of blood accumulated in the aspiration equipment and the amount of blood on the surgical gauze using an alkaline hematin technique

  during the operation

Secondary Outcomes (2)

• Operation time

  1 hour

• Myomectomy time

  30 minutes

Study Arms (3)

tranexamic acid

EXPERIMENTAL

Patients in the TXA group will be given 15 mg/kg of tranexamic acid (Cyklokapron@; Amoun Pharmaceutical Co., SAE) slowly intravenously 30 min before surgery followed by 10 mg/ kg/h infusion in 500 ml Ringer's by infusion pump till the end of the procedure.

Drug: Tranexamic Acid

oxytocin

ACTIVE COMPARATOR

An equal volume of normal saline syringe in a double blinded manner will be intravenously administered to the OXYtocin group 30 min before surgery and will be followed by one ampoule of oxytocin (10 U/mL/amp) (Syntocinon; Aventis Pharmaceutical Co.) will be added to 500 mL Ringer's solution running at a rate of 400 mU/min by infusion pump till the end of the procedure.

Drug: oxytocin

placebo

PLACEBO COMPARATOR

An equal volume of normal saline syringe in a double blinded manner will be intravenously administered to the oxytocin group 30 min before surgery and will be followed by 500 ml saline infusion during the operation

Drug: placebo

Interventions

Tranexamic Acid DRUG

Patients in the TXA group will be given 15 mg/kg of tranexamic acid (Cyklokapron@; Amoun Pharmaceutical Co., SAE) slowly intravenously 30 min before surgery followed by 10 mg/ kg/h infusion in 500 ml Ringer's by infusion pump till the end of the procedure.

tranexamic acid

oxytocin DRUG

An equal volume of normal saline syringe in a double blinded manner will be intravenously administered to the OXYtocin group 30 min before surgery and will be followed by one ampoule of oxytocin (10 U/mL/amp) (Syntocinon; Aventis Pharmaceutical Co.) will be added to 500 mL Ringer's solution running at a rate of 400 mU/min by infusion pump till the end of the procedure.

oxytocin

placebo DRUG

An equal volume of normal saline syringe in a double blinded manner will be intravenously administered to the Oxytocin group 30 min before surgery and will be followed by 500 ml saline infusion during the operation

placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age group (18-50) years old
• Intramural or interstitial myomas (more than 5 cm)
• Symptomatic myomas (heavy menstrual bleeding or pain during menstruation)
• Abdominal myomectomy
• No medical disorders
• No coagulation disorders

You may not qualify if:

• Age group (less than 18 yrs old)
• Age group (more than 50 yrs old)
• Subserous or submucous myomas
• Laparoscopic or hysteroscopic myomectomy
• Medical disorders (for example uncontrolled hypertension, diabetes mellitus, renal or hepatic disorders)
• Coagulation disorders
• Previous use of anticoagulant drugs
• Previous myomectomy
• Allergy to Tranexamic acid or oxytocin
• Malignant features by U/S or examination
• Pregnancy
• Previous hormonal therapy (GnRH analogues)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of medicine Cairo university

Giza, 11231, Egypt

Location

MeSH Terms

Interventions

Tranexamic Acid; Oxytocin

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• AHMED SAMY, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of obstetrics and gynecology

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 27, 2019
• Study Start: April 30, 2019
• Primary Completion: February 1, 2020
• Study Completion: March 15, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

EG (1)