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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02733952
Other study ID # ASUObGyn
Secondary ID
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


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
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