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

• Status: Unknown status
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams Maternity Hospital
• Treatments: Tranexamic Acid

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.