Vaginal Misoprostol Versus Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy

Vaginal Misoprostol Versus Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy , a Randomized Control Trail

The study aims at comparison between the effect of preoperative misoprostol and bilateral uterine artery ligation regarding their effect to decrease blood loss in transabdominal myomectomy.

Study Overview

• Status: Unknown
• Conditions: Vaginal Misoprostol and Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy
• Intervention / Treatment: Drug: preoperative vaginal misoprostol; Procedure: bilateral uterine artery ligation

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: walid basuony basuony, lecturer; Phone Number: 01001763042; Email: walidbasuony@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • ain shams University
    • Contact: walid basuony, lecturer; Phone Number: 0100763042; Email: walidbasuony@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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) ultrasound (abdominal or transvaginal) to confirm the clinical diagnosis:
• maximum diameter of the largest fibroid is greater than 4 cm
• maximum number of uterine myomas is not to be more than 5 myomas
• uterine fibroid may be subserous or intramural

Exclusion Criteria:

• obesity (BMI >30 kg/m2)
• cardiac, endocrine, pulmonary or hematological disease (including anemia; hemoglobin level below 10 gm/dl)
• patients known to be allergic to prostaglandin preparations
• patients who received preoperative hormonal therapy (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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: misoprostol group; preoperative vaginal misoprostol in decreasing blood loss in transabdominal myomectomy	Drug: preoperative vaginal misoprostol; preoperative vaginal misoprostol 400 micrograms 1 hour before surgery; Other Names: cytotec
Active Comparator: uterine artery ligation group; bilateral uterine artery ligation in decreasing blood loss in transabdominal myomectomy	Procedure: bilateral uterine artery ligation; bilateral ascending uterine artery ligation at the level of uterine isthmus with 2/0 vicryl sutures; Other Names: devascularization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
estimated intraoperative blood loss measured in milliliters	60 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the need of intra-operative blood transfusion	Below a hemoglobin concentration of 7 g/dL requiring 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).	60 min
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 when it is impossible to reconstruct the uterus because of the many defects left by the removal of multiple fibroids	60 min
operative time in minutes		60 min
intraoperative or postoperative complications		24 hours
differance between pre and post operative hemoglobin and hematocrit levels		24 hours
duration of hospital stay in days		7 days

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: December 21, 2015
• First Submitted That Met QC Criteria: December 29, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Estimate): December 31, 2015
• Last Update Submitted That Met QC Criteria: December 29, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: ASUMH