Uterine myomas are benign tumors of the uterus. Abdominal myomectomy, the surgical removal of myomas, is an important treatment option especially for women who wish to preserve their uteri.The major problem with myomectomy is excessive bleeding, which can be life threatening and prolong postoperative stay. The aim of this study, is to assess the effectiveness, and safety of oxytocin to reduce blood loss during myomectomy. In this double blind, randomized, and placebo-controlled clinical trial, 80 patients requiring surgical myomectomy by laparotomy will be study. Patients will be randomize to two groups. In the study group (40 patients) oxytocin 30 u in 1000 ml normal saline administer during myomectomy and in the placebo group (40 patients) normal saline alone will be administered. The main outcome measures are peri-operative blood loss and rates of blood transfusion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211217013N3
Registration date:2012-12-09, 1391/09/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-09, 1391/09/19
Registrant information
Name
Simin Atashkhoei
Name of organization / entity
Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 3806
Email address
atashkhoii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Women's Reproductive Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2012-11-05, 1391/08/15
Expected recruitment end date
2013-08-06, 1392/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oxytocin infusion on reducing operative blood loss during abdominal myomectomy
Public title
Effect of oxytocin infusion on reducing operative blood loss during abdominal myomectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Including criteria: Women undergoing abdominal myomectomy; over 35 years age
Excluding criteria: Patients candidate for hysteroscopic myomectomy; Patients with preoperative GnRH agonist consumption; Patients with history of cardiopulmonary disease
Age
From 35 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Vice chancellor for research, Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz University of Medical Sceinces, Daneshgah square, Tabriz
City
Tabriz
Postal code
Approval date
2012-11-04, 1391/08/14
Ethics committee reference number
91126
Health conditions studied
1
Description of health condition studied
Bleeding during abdominal myomectomy
ICD-10 code
D25
ICD-10 code description
Leiomyoma of uterus
Primary outcomes
1
Description
The amount of bleeding
Timepoint
During myomectomy
Method of measurement
Count sponges and the amount of blood collected in the suction device - according to ml
Secondary outcomes
1
Description
The amount of blood transfusion
Timepoint
Intra and postoperative
Method of measurement
Observation, Physical examination- Blood unit according to ml
2
Description
Hb and HcT values
Timepoint
Prior to operation and 24 h after operation
Method of measurement
Elyza method-CBC[ Hb(g/dl), HcT(%)}
Intervention groups
1
Description
In the study group (n=40) oxytocin 30 u into 1000 ml normal saline will be infused during myomectomy.
Category
Treatment - Drugs
2
Description
In the placebo group (n=40) normal saline alone 1000 ml will be infused during myomectomy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Operating Room and Cesarean setting, Al Zahra Hospital, Tabriz University of Medical Sciences,
Full name of responsible person
Dr. Simin Atashkhoei
Street address
Al Zahra hospital, Artesh Jonoubi Ave,Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Elahe Olade Saheb Madarek
Street address
Al Zahra hospital, Artesh Jonoubi Ave, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Women's Reproductive Health Research Center, 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
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoei
Position
Associate Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Al Zahra hospital, Artesh Jonoubi Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
siminatashkhoii@yahoo.comsatashkhoyi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Women's Reproductive Health Research Center,Tabriz University of Medical Sciences
Full name of responsible person
Dr Simin Atashkhoyi
Position
Associate Professor, Specialist in anesthesiology
Other areas of specialty/work
Street address
Al Zahra Hospital, Artesh Jonoubi Ave,Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
siminatashkhpii@yahoo.comsatashkhoyi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Associate Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Alzahra Hospital, Artesh Jonoubi Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
siminatashkhoii@yahoo.comsatashkhoyi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)