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

Post Operative Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02733952
• Other study ID #: ASUObGyn
• Status: Recruiting
• Phase: Phase 3
• First received: March 27, 2016
• Last updated: April 6, 2016
• Start date: August 2015
• Est. completion date: August 2017

Study information

• Verified date: April 2016
• Source: Ain Shams Maternity Hospital
• Contact: Mohamad A Ismail, MD
• Phone: 01200523523
• Email: mohamad.abdelhamid[@]hotmail.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Post Operative Hemorrhage
• Postoperative Hemorrhage

Intervention

Drug:
• Tranexamic Acid

Procedure:
• Pericervical Tourniquet

Locations

Country	Name	City	State
Egypt	Ain shams university maternity hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated intra-operative blood loss measured in milliliters		first 24 hours postoperative	Yes
Secondary	The need for intra-operative blood transfusion	It is indicated when intra-operative blood loss exceeds 15% of the patient's estimated blood volume, which is equal to the patient's weight in kilograms multiplied by 10	1 hour	Yes
Secondary	The need for conversion from myomectomy to hysterectomy	It is indicated when there is uncontrolled intra-operative hemorrhage affecting the patient's vital signs and not responsive to conservative measures or when it is impossible to reconstruct the uterus because of the many defects left by the removal of multiple fibroids	1 hour	Yes
Secondary	Operative time in minutes		1 hour	Yes
Secondary	Intra-operative or post-operative complications		24 hours	Yes
Secondary	Difference between Pre and post-operative hemoglobin and hematocrit levels	Postoperative hemoglobin and hematocrit levels are to be measured 24 hours after the operation via a venous blood sample).	24 hours	Yes
Secondary	Duration of hospital stay in days		7 days	Yes