Comparison of intra-myomic injection of oxytocin and intramural vasopressin in reducing laparoscopic myomectomy bleeding in women referred to Rasool Akram Hospital from 2021-2022
Design
The clinical trial has a control group, with parallel groups, double-blind, randomized, phase 2 on 60 patients. To randomize the balls, the balls are taken out of the container without replacement and the created sequence is recorded.
Settings and conduct
The study site is the operating room of the gynecology ward of Rasoul Akram Hospital in Tehran, which is performed on all patients undergoing laparoscopic myomectomy. This is a double-blind trial in which the participant, the data collector, and the data analyzer are blind to the type of drug. One participant receives oxytocin and the other vasopressin, and the patient is told that he or she will receive one of these two drugs, and data is sent to the analyzer named A and B, without knowing their nature.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 20 to 45 years; Symptomatic uterine fibroids candidate for laparoscopic surgery, non-response to drug therapy.
Non-inclusion criteria:
Underlying diseases related to blood factors; Pregnancy; Women who are candidates for hysterectomy; History of adverse reaction or allergy to vasopressin; active cardiovascular or pulmonary disease indicating difficulty using vasopressin
Intervention groups
Intervention group: Vasopressin is diluted with a concentration of 0.2 U / ml and injected intramyometrialy (between myoma and uterus) and subcapsulary.
Control group: Prophylaxis oxytocin is diluted and injected intramyometrialy (between the myoma and the uterus) and subcapsulary. For this purpose, a 10 mg ampoule is diluted with 300 cc of normal saline and 100 cc is injected.
Main outcome variables
Amount of blood loss during surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150817023666N15
Registration date:2022-07-03, 1401/04/12
Registration timing:prospective
Last update:2022-07-03, 1401/04/12
Update count:0
Registration date
2022-07-03, 1401/04/12
Registrant information
Name
Abolfazl Mehdizadeh kashi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 216651500
Email address
mehdizadeh.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-21, 1401/04/30
Expected recruitment end date
2025-02-18, 1403/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intra-myomic injection of oxytocin and intramural vasopressin in reducing laparoscopic myomectomy bleeding in women with myoma
Public title
The effect of oxytocin and vasopressin in reducing laparoscopic myomectomy bleeding in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 20 to 45 years
Symptomatic uterine fibroids candidate for laparoscopic surgery
No response to drug treatment
Exclusion criteria:
Underlying diseases related to blood factors
Pregnancy
Women who are candidates for hysterectomy
People for whom anesthesia is harmful
A history of an adverse reaction or allergy to vasopressin, and an active cardiovascular or pulmonary disease that indicates a problem with vasopressin use.
Long QT interval
Leiomyoma located in the area of the uterus that connects to the arteries or ligaments of the uterus or cervix and is difficult to remove without hysterectomy.
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, with a sample size of 60 people, 30 balls for intervention group A and 30 balls for intervention group B were placed in a lottery container and then the balls were randomly pulled out from the container without replacement.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study. The participant, the data collector, and the data analyzer are blind to the type of drug. One participant receives oxytocin and the other vasopressin, and the patient is told that he or she will receive one of these two drugs, and data is sent to the analyzer named A and B, without knowing their nature.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
The volume of suctioned blood is measured during the operation, after surgery and 12 hours after the operation.
Method of measurement
Measurement of blood hemoglobin
Secondary outcomes
1
Description
Fever
Timepoint
Before and after surgery and 12 hours after surgery
Method of measurement
Patient's file (document)
2
Description
Infection
Timepoint
Before and after surgery and 12 hours after surgery
Method of measurement
Patient's file (document)
3
Description
Duration of surgery
Timepoint
Before and after surgery and 12 hours after surgery
Method of measurement
Patient's file (document)
4
Description
Duration of hospitalization
Timepoint
Before and after surgery and 12 hours after surgery
Method of measurement
Patient's file (document)
5
Description
Postoperative side effects such as allergies
Timepoint
Before and after surgery and 12 hours after surgery
Method of measurement
Patient's file (document)
6
Description
Cardiovascular disorders
Timepoint
Before and after surgery and 12 hours after surgery
Method of measurement
Patient's file (document)
7
Description
Pulmonary edema
Timepoint
Before and after surgery and 12 hours after surgery
Method of measurement
Patient's file (document)
Intervention groups
1
Description
Control group: Prophylaxis oxytocin is diluted and injected intramyometrialy (between the myoma and the uterus) and subcapsulary. For this purpose, a 10 mg ampoule is diluted with 300 cc of normal saline and 100 cc is injected.
Category
Treatment - Drugs
2
Description
Intervention group: Vasopressin is diluted with a concentration of 0.2 U / ml and totally 4-6 units is injected intramyometrialy (between myoma and uterus) and subcapsulary.