The main objective of this study is Comparing the intraoperative outcomes of intrauterine instillation of E-Aminocaproeic Acid and intravenous oxytocin in hysteroscopy surgeries. This study is a single blind clinical trial.
The study included 144 patients with Treatment resistant abnormal uterine bleeding that hospital visit and has been nominated for hysteroscopy can be performed and are divided in to two groups(77 person).
Patients with endometrial thickening, and submucosal uterine myoma less than 5 cm include and the patient with hepatic renal and cardiovascular disorders, and metabolic diseases will be excluded.
In the first group two grams of E-Aminocaproeic Acid per liter of 5% dextrose saline for intrauterine induction and hysteroscopy used and in the second group only5% dextrose saline for uterine and intravenous 10 IU / L oxytocin used during surgery.
for both groups Suitable Temperature of serum is room temperature. Hysteroscopy minute period for both groups will be identified. The primary outcome was to determine the amount of bleeding during surgery with using a visual scale would be zero(no hemorrhage) to 4 (severe bleeding passing clots) will be different.
Anesthetic peri operative complications were reported as secondary outcomes.
Prepare serum and the drug will be done by the operating room nurse and surgeon in all cases, a person will be.
All under general anesthesia and placed in amanner and form. Blood transfusion and post operative hospital stay were reported.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409235283N10
Registration date:2014-10-14, 1393/07/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-10-14, 1393/07/22
Registrant information
Name
Manizheh Sayyah Melli
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 3741
Email address
sayyahmellim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research,Tabriz University Of Medical Sciences
Expected recruitment start date
2014-10-24, 1393/08/02
Expected recruitment end date
2015-10-24, 1394/08/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the intraoperative outcomes of intrauterine instillation of E-Aminocaproeic Acid and intravenous oxytocin in hysteroscopy surgeries
Public title
Comparison the intraoperative outcomes of intrauterine instillation of E-Aminocaproeic Acid and intravenous oxytocin in hysteroscopy surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: history of persistent uterine bleeding accompanied with endometrial thickness, endometrial polyp or submucous myoma less than 5 cm in diameters and patients' willing to participate
Exclusion criteria: Patients with the history of cardiopulmonary and liver disease, hypertension, diabetes, hyperlipidemia, cervical and uterine cancers, submucous myomas more than 5 cm in diameters
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Approval date
2014-06-26, 1393/04/05
Ethics committee reference number
9344
Health conditions studied
1
Description of health condition studied
Polyp of corpus uteri
ICD-10 code
N84.0
ICD-10 code description
Polyp of corpus uteri
2
Description of health condition studied
endometrial tickness
ICD-10 code
N85.0
ICD-10 code description
Endometrial glandular hyperplasia
3
Description of health condition studied
Submucous leiomyoma
ICD-10 code
D25.0
ICD-10 code description
Submucous leiomyoma of uterus
Primary outcomes
1
Description
Interaoperative bleeding
Timepoint
at the end of surgery
Method of measurement
Visual scale
2
Description
duration of surgery
Timepoint
from the beginning to the end of surgery
Method of measurement
Questionnaire
3
Description
volume of injected media
Timepoint
after finishing of every one litre serum
Method of measurement
number of injected serums
Secondary outcomes
1
Description
blood pressure
Timepoint
continious
Method of measurement
monitor
2
Description
bradycardia
Timepoint
continious
Method of measurement
monitor
3
Description
gastrointestinal side effects
Timepoint
every 1 hour
Method of measurement
clinical signs and symptoms
4
Description
headache
Timepoint
every 1 hours
Method of measurement
clinical symptoms
5
Description
post operative bleeding
Timepoint
every 15 minuts
Method of measurement
clinical signs and symptoms
6
Description
duration of hospital stay
Timepoint
From admission to discharge
Method of measurement
Questionnaire
Intervention groups
1
Description
Group B: placebo i.e., dextrose 5% in the same form inside one liter of the dextrose 5%
Category
Placebo
2
Description
Group A: E-Aminocaproeic Acid in dextrose 5% inside one liter of the dextrose 5%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr.Manizheh Sayyah-Melli
Street address
Alzahra Hospital, South Artesh Ave
City
T
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Alireza Rashidi
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research,Tabriz University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Manizhe Sayyah-Melli
Position
prof. of Ob & Gyn
Other areas of specialty/work
Street address
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Postal code
5138665793
Phone
+98 41 3553 9161
Fax
Email
wrhrcenter@gmail.com;lahroudin@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Manizhe Sayyah-Melli
Position
prof. of Ob & Gyn
Other areas of specialty/work
Street address
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Postal code
5138665793
Phone
+98 41 3553 9161
Fax
Email
wrhrcenter@gmail.com;lahroudin@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr.Manizheh Sayyah-Melli
Position
Other areas of specialty/work
Street address
City
Postal code
5138665793
Phone
+98 41 3553 9161
Fax
Email
wrhrcenter@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)