Comparative study of intravenous tranexamic acid and intravenous oxytocin in the control of bleeding during hysterescopic myomectomy in women with abnormal uterin bleeding
The main objective of this study is comparative study of intravenous tranexamic acid and intravenous oxytocin in the control of bleeding during hysterescopic myomectomy in women with abnormal uterin bleeding. The study included 140 patients with complaints abnormal uterine bleeding that refer to Alzahra hospital for hysteroscopic myomectomy will be done. Patients randomly using random software list will be divided into two groups of 70 people. Patients with abnormal uterine bleeding and submucosal myoma with a diameter of 30 mm or less and zero or first grade will be incloud to this study. of All patients in both groups of informed consent will be obtained. Both groups were matched for age, gravid, parity and the number of myoma And patients with a history of underlying disease, submucosal larger than 3 cm will be excluded.
Random selection will be done by a nurse, that aware of the details of an investigation. Doctors and patients to selected groups will be blind. In both groups after general anesthesia and cervical dilatation, 5% dextrose solution will be used as the medium for uterine cavity distention and will be withdraw completely myoma and Upon entering hysteroscop in to uterus, the first group received tranexamic acid 10 mg / kg in 500 ml Ringer serom in 10 minutes and the second group,five units of oxytocin in 500 ml serum ringer 10 minute intravenous infusion at will In this study, the changes of hemoglobin as the primary outcome and duration of surgery and the success rate in Myomectomy, is considered secondary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105306563N2
Registration date:2016-10-25, 1395/08/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-25, 1395/08/04
Registrant information
Name
Mehri Jafari Shobeiri
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
jafarim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research,Tabriz University Of Medical Sciences
Expected recruitment start date
2016-10-17, 1395/07/26
Expected recruitment end date
2018-02-15, 1396/11/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of intravenous tranexamic acid and intravenous oxytocin in the control of bleeding during hysterescopic myomectomy in women with abnormal uterin bleeding
Public title
Comparative study of intravenous tranexamic acid and intravenous oxytocin in the control of bleeding during hysterescopic myomectomy in women with abnormal uterin bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Medium and persistent abnormal uterine bleeding; Report on transvaginal ultrasound submucosal myoma diameter 30 mm or less and grade zero or one; Exclusion criteria:
Patients with a history of heart disease; Hepatic; Diabetes;
Thromboembolism; Cancer of the uterus and cervix; Submucosal leiomyoma larger than 3 cm;
Uterine septum; pregnant women; Severe bleeding; Anti coagulation therapy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences.
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Postal code
Approval date
2016-10-05, 1395/07/14
Ethics committee reference number
IR.TBZMED.REC.1395.689
Health conditions studied
1
Description of health condition studied
Abnormal uterine and vaginal bleeding
ICD-10 code
N93
ICD-10 code description
Other abnormal uterine and vaginal bleeding
Primary outcomes
1
Description
The hemoglobin concentration
Timepoint
Six hours after surgery
Method of measurement
Blood test
Secondary outcomes
1
Description
Duration of surgery.
Timepoint
After surgery
Method of measurement
Questionnaire
2
Description
The success of myomectomy
Timepoint
After surgery
Method of measurement
Observation
Intervention groups
1
Description
the first group received tranexamic acid 10 mg / kg in 500 ml Ringer serom in 10 minutes
Category
Treatment - Drugs
2
Description
The second group,five units of oxytocin in 500 ml serum ringer 10 minute intravenous infusion
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr.Mehri Jaefari Shobeiri
Street address
Alzahra Hospital, South Artesh St.,Tabriz, iran
City
Tabriz
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
Mehri Jaefari Shobeiri
Position
Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
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
Mehri Jaefari Shobeiri
Position
Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
lahroudin@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Mehri Jaefari Shobeiri
Position
Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
lahroudin@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)