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

NCT ID: NCT02733952

Last Updated: 2016-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-08-31

Brief Summary

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

Detailed Description

this study aims at comparing between different methods to decrease blood loss in trans-abdominal myomectomy. this study compares between medical (intravenous tranexamic acid administration) and non medical (pericervical tourniquet) methods in decreasing blood loss intra operative

Conditions

Post Operative Hemorrhage

Study Design

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

Study Groups

tranexamic acid

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)

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type: DRUG

Pericervical Tourniquet

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

Group Type: ACTIVE_COMPARATOR

Pericervical Tourniquet

Intervention Type: PROCEDURE

Interventions

Tranexamic Acid

Intervention Type: DRUG

Pericervical Tourniquet

Intervention Type: PROCEDURE

Other Intervention Names

Kapron

Eligibility Criteria

Inclusion Criteria

• • 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams Maternity Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Bahaa Eldin Ahmed

Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmad M BahaaEldin, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams university maternity hospital

Locations

Ain shams university maternity hospital

Cairo, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamad A Ismail, MD

Role: CONTACT

mohamad.abdelhamid@hotmail.com

01200523523 ext. 002

Ahmad M BahaaEldin, MD

Role: CONTACT

abahaa0503@yahoo.com

01111700556 ext. 002

Facility Contacts

Mohamad A Ismail, MD

Role: primary

mohamad.abdelhamid@hotmail.com

01200523523 ext. 002

Ahmed M Bahaaeldein, MD

Role: backup

abahh0503@yahoo.com

01111700556 ext. 002

Other Identifiers

ASUObGyn

Identifier Type: -

Identifier Source: org_study_id