NCT05154279

Brief Summary

Our study aims to evaluate the efficacy of intramyometrial injection of Terlipressin versus intramyometrial injection of Carbetocin on hemoglobin level in women undergoing abdominal myomectomy. Moreover, to evaluate their efficacy in decreasing blood loss on operative time and to describe the injection sequelae for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 13, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

February 27, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

June 25, 2024

Status Verified

October 1, 2023

Enrollment Period

2.8 years

First QC Date

November 29, 2021

Last Update Submit

June 24, 2024

Conditions

Laparoscopic Myomectomy

Keywords

laparoscopic myomectomyTerlipressincarbitocin

Outcome Measures

Primary Outcomes (1)

  • effect of intramyometrial terlipressin vs carbitocin vs saline on decreasing blood loss in laparoscopic myomectomy

    1- To evaluate the efficacy of intramyometrial injection of Terlipressin versus intramyometrial injection of Carbetocin in decreasing blood loss in women undergoing laparoscopic myomectomy

    12 hours

Secondary Outcomes (2)

  • effect of intramyometrial terlipressin vs carbitocin vs saline on decrease hemoglobin level in laparoscopic myomectomy

    24 hours

  • effect of intramyometrial terlipressin vs carbitocin vs saline on operative time

    12 hours

Study Arms (3)

intramyometrial Terlipressin

ACTIVE COMPARATOR

intramyometrial injection of Terlipressin in women undergoing laparoscopic myomectomy procedure

Drug: Terlipressin

intramyometrial carbitocin

ACTIVE COMPARATOR

intramyometrial injection of Carbetocin in women undergoing laparoscopic myomectomy procedure

Drug: Terlipressin

intramyometrial saline

PLACEBO COMPARATOR

intramyometrial injection of saline in women undergoing laparoscopic myomectomy procedure

Drug: Terlipressin

Interventions

TerlipressinDRUG

intramyometrial terlipressin vs carbitocin vs saline as placebo

Also known as: carbitocin, saline
intramyometrial Terlipressinintramyometrial carbitocinintramyometrial saline

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Women aged 16-45 years
  • Appropriate medical status for laparoscopic surgery (largest myoma ≤15 cm)
  • Baseline hemoglobin ≥9 g/dl
  • No contra-indications to the use of glyopressin or carbitocin
  • Myoma-related symptoms, such as pelvic pressure or pain, menorrhagia, or infertility
  • Not pregnant at the time of presentation (i.e., negative urine pregnancy test or last menstrual period within the last 4 weeks)

You may not qualify if:

  • Previous myomectomy
  • History of bleeding disorders
  • Concurrent anticoagulation therapy
  • History of Uncontrolled ischaemic heart disease
  • Any pelvic abnormalities requiring concomitant surgery
  • Treatment with a GnRH agonist or ulipristal acetate within three months preceding surgery
  • Inability to understand and provide written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Research center

Cairo, Egypt

RECRUITING

Wael El Banna Clinic

Maadi, Egypt

RECRUITING

MeSH Terms

Interventions

TerlipressinSodium Chloride

Intervention Hierarchy (Ancestors)

LypressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Wael El Banna

CONTACT

01227760402waelelbanna@drwaelelbanna.com

Esraa mohammad

CONTACT

01212421260esraamoghawry@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 13, 2021

Study Start

February 27, 2022

Primary Completion

December 30, 2024

Study Completion

March 30, 2026

Last Updated

June 25, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access
Study Protocol Access

Locations

EG(2)