Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In Trans-Abdominal Myomectomy

NCT02733952 | Unknown Phase 3 DMC

• 1 other identifier: ASUObGyn
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In Trans-Abdominal Myomectomy

Conditions

Post Operative Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Estimated intra-operative blood loss measured in milliliters

  first 24 hours postoperative

Secondary Outcomes (6)

• The need for intra-operative blood transfusion

  1 hour

• The need for conversion from myomectomy to hysterectomy

  1 hour

• Operative time in minutes

  1 hour

• Intra-operative or post-operative complications

  24 hours

• Difference between Pre and post-operative hemoglobin and hematocrit levels

  24 hours

Study Arms (2)

tranexamic acid

ACTIVE COMPARATOR

bolus intravenous injection of tranexamic acid 10mg/kg (maximum1g) 15 min before incision followed by continuous infusion of 1mg/kg/h dissolved in 1L of saline for 10 h (maximum 1 g/10 h)

Drug: Tranexamic Acid

Pericervical Tourniquet

ACTIVE COMPARATOR

The tourniquet method will be used where the urinary bladder will be dissected downwards from the lower uterine segment, and then a perforation will be made in the posterior leaflet of the broad ligament bilaterally at the level of uterine isthmus. A tourniquet (using 16- inch Foley catheter) will be passed through the perforation encircling the uterine arteries bilaterally. The Fallopian tubes and the ovaries will be carefully excluded from the line of the tourniquet to avoid direct compression and necrosis. The tourniquet will be released intermittently (at about 30 minutes interval) during the surgery and finally removed after the repair of the uterus

Procedure: Pericervical Tourniquet

Interventions

Tranexamic Acid DRUG

Also known as: Kapron

tranexamic acid

Pericervical Tourniquet PROCEDURE

Pericervical Tourniquet

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women in the reproductive age (20 - 40 years) diagnosed as having uterine fibroids who are consenting to have trans-abdominal myomectomy in the postmenstrual period diagnosed by:
• Clinical symptoms and signs:
• Abnormal uterine bleeding (menorrhagia or (and) metrorrhagia).
• Pain (dull aching lower abdominal pain or dysmenorrhea).
• Pressure symptoms (dyspareunia, dysuria, dyschezia or (and) backache).
• Progressive abdominal enlargement (abdominal swelling).
• All women with clinical presentation suggestive of uterine fibroid will undergo abdominal and trans-vaginal ultrasound to confirm the clinical diagnosis and to exclude patients with:
• Submucous uterine myomas.
• Cervical or supracervical myomas.
• Broad ligamentary and pedunculated myomas.
• Associated pelvic pathology.
• Ultrasound criteria of uterine fibroids of included patients:
• Maximum diameter of the largest fibroid is greater than 4cm.
• Maximum number of uterine myomas is not to be more than 5 myomas.
• Uterine fibroid may be subserous or intramural.

You may not qualify if:

• Obesity (body mass index \>30 kg/m2).
• Cardiac, endocrine, pulmonary or hematological disease (including anemia; hemoglobin level below 10gm/dl).
• Patients known to be allergic to tranexamic acid.
• Patients who received pre-operative hormonal therapy (such as a GnRH analogue).
• Patients presented by or with suspected malignant gynecological disease.
• Patients diagnosed as having submucous uterine fibroids, cervical or supracervical fibroids, broad ligamentary fibroids and pedunculated fibroids.
• Patients with contraindication to general anaesthesia.
• Patients with positive pregnancy test.
• Virgin patients.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain shams university maternity hospital

Cairo, Cairo Governorate, 02002, Egypt

RECRUITING

MeSH Terms

Conditions

Postoperative Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Ahmad M BahaaEldin, MD

  Ain Shams university maternity hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamad A Ismail, MD

CONTACT

01200523523; mohamad.abdelhamid@hotmail.com

Ahmad M BahaaEldin, MD

CONTACT

01111700556; abahaa0503@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: March 27, 2016
• First Posted: April 12, 2016
• Study Start: August 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 12, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)