Clinical trial NCT02733952: Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In Trans-Abdominal Myomectomy
Official title: Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In Trans-Abdominal Myomectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Post Operative Hemorrhage
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Primary outcomes:
measure: Estimated intra-operative blood loss measured in milliliters
timeFrame: first 24 hours postoperative
Secondary outcomes:
measure: The need for intra-operative blood transfusion
timeFrame: 1 hour
measure: The need for conversion from myomectomy to hysterectomy
timeFrame: 1 hour
measure: Operative time in minutes
timeFrame: 1 hour
measure: Intra-operative or post-operative complications
timeFrame: 24 hours
measure: Difference between Pre and post-operative hemoglobin and hematocrit levels
timeFrame: 24 hours
measure: Duration of hospital stay in days
timeFrame: 7 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university maternity hospital
Study officials:
affiliation: Ain Shams university maternity hospital
name: Ahmad M BahaaEldin, MD
role: PRINCIPAL_INVESTIGATOR
References: