Topical Tranexamic Acid Plus Perivascular Vasopressin at the Time of Abdominal Myomectomy

NCT03880045 | Unknown DMC

• 1 other identifier: aswu/206/19
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators will investigate the effectiveness of a topical tranexamic acid plus perivascular vasopressin compared with perivascular vasopressin alone for the reduction of blood loss at the time of myomectomy

Conditions

Myoma

Keywords

abdominal myomectomy; tranexamic acid; vasopressin

Outcome Measures

Primary Outcomes (1)

• measure will be Mean amount of blood loss

  measure will be Mean amount of blood loss by gravimetric methods

  intraoperative

Secondary Outcomes (1)

• the number of the patients need of blood transfusion

  24 hours post delivery

Study Arms (2)

Topical TA plus vasopressin

ACTIVE COMPARATOR

Intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy plus gauze soaked with 2 g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride0.9%

Drug: Topical TA; Drug: vasopressin

placebo to TA plus vasopressin

ACTIVE COMPARATOR

Intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy plus placebo to tranexamic acid

Drug: vasopressin; Other: placebo to TA

Interventions

Topical TA DRUG

A gauze soaked with 2 g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride0.9%

Also known as: Active comparator

Topical TA plus vasopressin

vasopressin DRUG

intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy

Also known as: Active Comparator

Topical TA plus vasopressin; placebo to TA plus vasopressin

placebo to TA OTHER

(120 ml of sodium chloride 0.9%) used to compress the myoma bed for 5 min.

Also known as: placebo comparator

placebo to TA plus vasopressin

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: All women who prepared for abdominal myomectomies will be invited to participate in the study
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
• Age ≥ 18 years and ≤ 50 years
• Pre-operative hemoglobin \>8 g/dl
• Ability to understand and the willingness to sign a written informed consent.
• Admissible medical/surgical history
• Five or less symptomatic uterine myomas
• All myomas are subserous or intramural.
• Uterine size less than 24 weeks of pregnancy

You may not qualify if:

• Patients who have had a prior abdominal myomectomy
• Post-menopausal women
• Patients with known bleeding/clotting disorders
• Patients with a history of gynecologic malignancy
• Hypertension.
• Cardiac and Pulmonary Diseases.
• Obesity (body mass index \> 30 kg/m2).
• History of allergic reactions attributed to misoprostol
• Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Conditions

Myoma; Diabetes Insipidus

Interventions

Vasopressins

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• hany f allam, md

  Aswan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hany f allam, md

CONTACT

0102236052; hany.farouk@aswu.edu.eg

nahla w shady, md

CONTACT

01092440504; nahla.elsayed@aswu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A double-blinded randomized controlled stud
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A double-blinded randomized controlled stud

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 19, 2019
• Study Start: April 1, 2019
• Primary Completion: March 30, 2021
• Study Completion: June 1, 2021
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)