Methods to Reduce Blood Loss in Abdominal Myomectomy

Status

Status unknown

Phase

Phase 4

Enrollment

120 participants (estimated)

Sponsor

Cairo University · Other

Design

Randomized · Single masking

Countries

Not stated

Start

1 Nov 2020 (estimated)

Primary completion

31 Aug 2022 (estimated)

Completion

15 Sept 2022 (estimated)

First posted

22 Oct 2020

Last update posted

22 Oct 2020

Conditions

Abdominal Myomectomy · Blood Loss

The aim of the study is to compare the effectiveness of a single preoperative dose of vaginal misoprostol, intraoperative oxytocin infusion, IV carbetocin and pericervical tourniquet for the reduction of blood loss during of abdominal myomectomy.

• Active comparator

  Misoprostol group

  receive two tablets of 200µg misoprostol (Pfizer Limited, United Kingdom) administered into the posterior fornix of the vagina 1 hour before the onset of surgery

• Active comparator

  Oxytocin group

  After induction of general anaesthesia and immediately prior to the operation, an infusion of 30 IU oxytocin in 500 ml normal saline at a rate of 120 ml/h will be started during myomectomy.

• Experimental

  Carbetocin group

  receive 100 μg IV Carbetocin (1ml) \[Pabal, Ferring (UK)\] in 5 ml saline over 1 minute just before skin incision

• Active comparator

  pericervical tourniquet group

  pericervical tourniquet using a Foley catheter size 18, which will be firmly tied at the level of the cervico-isthmic junction of the uterus before the uterine incision.

1. Intraoperative blood loss

   Time frame · baseline

   Registry description

   estimated by calculating the sum of canisters containing irrigation fluids and suctioned (ml)blood minus used irrigation solution plus the amount of absorbed blood in used sponges then converting weight with volume of blood loss as \[post-operative wet sponge weight in (grams) minus preoperative dry sponge weight (grams) which means 1 ml of blood weighs 1gm\].