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

NCT ID: NCT03892668

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2020-03-15

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.

Detailed Description

Interventions:

Preoperative

• Full history, where demographic characteristics will be reported and examination to detect the size and mobility of uterus.
• Informed consent will be taken from patients.
• Trans-vaginal U/S to assess number, size, and types of myomas.
• Preoperative full labs (Hemoglobin, hematocrit, INR, liver enzymes and kidney functions)

Intra Operative

• Preoperative antibiotics will be given before the beginning of the operation. The operations will be performed as standard through a midline or Pfannenstiel incision by the same consultant gynecologist to ensure consistency of study procedures. All patients will receive general anesthesia. After the skin incision, the subcutaneous fat and abdominal fascia will be opened crosswise, and the rectus muscle will be opened on the midline. The parietal peritoneum will be opened longitudinally to reach the pelvic cavity. Subsequently, a self-retaining retractor will be inserted, and intestine will be packed. The uterus will be inspected for the number, location, and shape of myomas. Other pelvic organs will be inspected for any associated pathology. When possible, uterine incisions will be performed on the anterior wall or fundus in order to reduce postoperative adhesions. The incision will be performed using monopolar diathermy. Intracapsular enucleation of myomas will be performed by gently dissecting between the myoma and the pseudo-capsule. The myoma will be gently enucleated out. Meticulous hemostasis will be secured by low-voltage coagulation of feeding vessels. Myoma bed will be closed by 1 or 2 layers of interrupted vicryl sutures (Vicryl 1-0 polyglactin 910; Egycryl, Taisier CO, Egypt). No mechanical tourniquet or local vasoocclusive drugs (e.g., vasopressin) will be used intraoperatively.
• The study will include patients scheduled for open abdominal myomectomy and will be divided into three equal groups.
• All the three groups will take a standard dose of 400 microgram of misoprostol rectally one hour before the operation.

Postoperative

• Estimation of Hemoglobin 6 hrs postoperatively and next day morning.
• Monitor Vital Signs and need for blood transfusion.
• Send myomas for pathology.

Conditions

Myomectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

tranexamic acid

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.

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: 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.

oxytocin

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.

Group Type: ACTIVE_COMPARATOR

oxytocin

Intervention Type: 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.

placebo

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: 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

Interventions

Tranexamic Acid

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.

Intervention Type: DRUG

oxytocin

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.

Intervention Type: DRUG

placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• • 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

Exclusion Criteria

• • 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Samy aly ashour

assistant professor of obstetrics and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AHMED SAMY, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

faculty of medicine Cairo university

Giza, , Egypt

Countries

Egypt

Other Identifiers

myomectomy

Identifier Type: -

Identifier Source: org_study_id