Methods to Reduce Blood Loss in Abdominal Myomectomy

NCT04595812 | Unknown Phase 4 DMC

• 1 other identifier: Reduce bleeding in myomectomy
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Abdominal Myomectomy; Blood Loss

Keywords

misoprostol; oxytocin; carbetocin; tourniquet

Outcome Measures

Primary Outcomes (1)

• Intraoperative blood loss

  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 \[post-operative wet sponge weight in (grams) minus preoperative dry sponge weight (grams) which means 1 ml of blood weighs 1gm\].

  baseline

Secondary Outcomes (7)

• The need for blood transfusion

  baseline

• Preoperative and postoperative haemoglobin and haematocrit values

  24 hours before and 24 hours after

• Perioperative blood pressure and HR

  Up to 4 hours postoperative

• Time of ambulation

  within 12 hours postoperative

• Post-operative hospital stay

  within 3 days postoperative

Study Arms (4)

Misoprostol group

ACTIVE COMPARATOR

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

Drug: Misoprostol 200mcg Tab vaginal

Oxytocin group

ACTIVE COMPARATOR

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.

Drug: Oxytocin

Carbetocin group

EXPERIMENTAL

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

Drug: Carbetocin

pericervical tourniquet group

ACTIVE COMPARATOR

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.

Procedure: pericervical hemostatic tourniquet

Interventions

Misoprostol 200mcg Tab vaginal DRUG

2 tablets vaginally 1 hour before surgery

Also known as: cytotec

Misoprostol group

Oxytocin DRUG

30 IU oxytocin in 500 ml normal saline at a rate of 120 ml/h

Oxytocin group

Carbetocin DRUG

100 μg IV Carbetocin (1ml) in 5 ml saline over 1 minute

Also known as: Pabal, Ferring (UK)

Carbetocin group

pericervical hemostatic tourniquet PROCEDURE

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,The time of tourniquet administration will be recorded, and will be released not later than 45 minutes after its application. For those requiring multiple applications, the tourniquet will be reapplied after a period of at least 15 minutes.

pericervical tourniquet group

Eligibility Criteria

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

You may qualify if:

• Age between 20-40 years.
• symptomatic intramural, submucous or subserous myomas by ultrasound
• Mean uterine fibroid size of 5-10 cm
• Presented with abnormal uterine bleeding, dull lower abdominal pain, infertility or recurrent miscarriage and are candidates for abdominal myomectomy.

You may not qualify if:

• History of previous abdominal or pelvic surgery (laparotomy) except Cesarian section.
• History of pelvic or ovarian endometriosis.
• History of PID.
• Patient with pedunculated subserous fibroid.
• Patients who are candidate for laparoscopic or hysteroscopic myomectomy.
• Allergy to misoprostol.
• Hypertension, Diabetes Mellitus, Cardiac and pulmonary diseases.
• Obesity BMI \> 30 kg/m².
• Anemia Hb \< 10 g/dL.
• Bleeding disorder or use of anticoagulation.
• Preoperative use of hormonal therapy as GnRH analogues or oral contraceptive pills.
• Pregnancy.
• Postmenopausal.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (7)

• Abdel-Hafeez M, Elnaggar A, Ali M, Ismail AM, Yacoub M. Rectal misoprostol for myomectomy: A randomised placebo-controlled study. Aust N Z J Obstet Gynaecol. 2015 Aug;55(4):363-8. doi: 10.1111/ajo.12359. Epub 2015 Jul 14.

  PMID: 26174128 BACKGROUND

• Atashkhoei S, Fakhari S, Pourfathi H, Bilehjani E, Garabaghi PM, Asiaei A. Effect of oxytocin infusion on reducing the blood loss during abdominal myomectomy: a double-blind randomised controlled trial. BJOG. 2017 Jan;124(2):292-298. doi: 10.1111/1471-0528.14416. Epub 2016 Nov 15.

  PMID: 27862855 BACKGROUND

• Farouk H, Shady N (2017) Intravenous Carbetocin to decrease blood loss during open myomectomy: a randomized placebo-controlled study. IJRCOG 7:

  BACKGROUND

• Gad Allah, S. H., A Wali, A., & Mostafa, S. (2015). Hemostatic effect and postoperative benefits of intramyometrial carbetocin injection during myomectomy: a randomized controlled trial. Evidence Based Women's Health Journal, 5(4), 185-189.

  BACKGROUND

• Gharabaghi PM, Alizadeh S, Atashkhoye S, Sayyah-Melli M, Jafari- Shobeiri M, Ouladsahebmadarek E, et al. Comparing the Outcomes and Side Effects of Administration of a Single Preoperative Dose of Vaginal Misoprostol With Intraoperative Oxytocin Infusion in Blood Loss During Abdominal Myomectomy. Int J Women's Health Reprod Sci 2017;

  BACKGROUND

• Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5.

  PMID: 25125317 BACKGROUND

• Ragab A, Khaiary M, Badawy A. The Use of Single Versus Double Dose of Intra-vaginal Prostaglandin E2 "Misoprostol" prior to Abdominal Myomectomy: A Randomized Controlled Clinical Trial. J Reprod Infertil. 2014 Jul;15(3):152-6.

  PMID: 25202673 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Interventions

Misoprostol; Oxytocin; carbetocin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ahmed Ibrahim Aref, professor

  Kasr Alainy Cairo University

  STUDY CHAIR

• Soumaya Mohamed AbouElew, professor

  Kasr Alainy Cairo University

  STUDY CHAIR

Central Study Contacts

Reham Hany Mohamed Elkhalifa

CONTACT

+201158778007; reham_khalifa1990@yahoo.com

Mohamed Ramadan Mohamed, lecturer

CONTACT

+201112246566

Study Design

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

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 22, 2020
• Study Start: November 1, 2020
• Primary Completion: August 31, 2022
• Study Completion: September 15, 2022
• Last Updated: October 22, 2020

Record last verified: 2020-10