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

NCT02643186 | Unknown Phase 4 DMC

• 1 other identifier: ASUMH
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• estimated intraoperative blood loss measured in milliliters

  60 min

Secondary Outcomes (6)

• the need of intra-operative blood transfusion

  60 min

• the need for conversion from myomectomy to hysterectomy

  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

Study Arms (2)

misoprostol group

ACTIVE COMPARATOR

preoperative vaginal misoprostol in decreasing blood loss in transabdominal myomectomy

Drug: preoperative vaginal misoprostol

uterine artery ligation group

ACTIVE COMPARATOR

bilateral uterine artery ligation in decreasing blood loss in transabdominal myomectomy

Procedure: bilateral uterine artery ligation

Interventions

preoperative vaginal misoprostol DRUG

preoperative vaginal misoprostol 400 micrograms 1 hour before surgery

Also known as: cytotec

misoprostol group

bilateral uterine artery ligation PROCEDURE

bilateral ascending uterine artery ligation at the level of uterine isthmus with 2/0 vicryl sutures

Also known as: devascularization

uterine artery ligation group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

walid basuony basuony, lecturer

CONTACT

01001763042; walidbasuony@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: university

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: December 31, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2017
• Last Updated: December 31, 2015

Record last verified: 2015-12

Locations

EG (1)