Objectives : Intravaginal misoprostol reduces intraoperative blood loss in myomectomy .
Design : Interventional
Setting & Conduct : Randomised-double blind . Use placebo . Single .
Participants : Women with uterus myoma that sceduled for myamectomy .
Inclusion criteria : Women with uterus myoma .
Exclusion criteria : Virgin patient ; Sensitive to misoprosto l ; Vaginal myomectomy ; Myomectomy assisted by hysteroscopy .
Sample size : 64
Intervention : Insert vaginal misoprostol in cese group .
Plasebo : Insert vaginal VIT B 6 in control group .
Major outcome : Estimate blood loss with comparison of Hb befor & 6 & 12hour after operation .
Secondary outcome : Reduction of operation time in case group .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013100714927N1
Registration date:2013-11-27, 1392/09/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-27, 1392/09/06
Registrant information
Name
Shima Hajiha
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3766
Email address
hajihashima@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-10-09, 1392/07/17
Expected recruitment end date
2014-01-10, 1392/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intravaginal misoprostol reduces intraoperative blood loss in myomectomy .
Public title
Intravaginal misoprostol can reduces blood loss in myomectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Women with intramural or subsrosal uterus myoma that they are the case of laparatomy myomectomy .
Exclusion criteria : Vaginal myomectomy ; Myomectomy assisted by hysteroscopy ; Virginity ; Misoprostol contraindications : liver diseas ; Epilepsy ; Sesnsitivity to misoprostol .
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
64
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 Tehran university of medical sciences
Street address
Ghods avenue , Keshavarz blv , tehran .
City
Tehran
Postal code
Approval date
2013-09-28, 1392/07/06
Ethics committee reference number
1420-130-ص-92
Health conditions studied
1
Description of health condition studied
uterus myoma
ICD-10 code
D25.1 , D2
ICD-10 code description
D25.1 Intramural leiomyoma of uterus D25.2 Subserosal leiomyoma of uterus
Primary outcomes
1
Description
Hemoglobin count .
Timepoint
Hemoglobin before & 6 houre & 12 houerafter operation
Method of measurement
Blood examination
Secondary outcomes
1
Description
Operation time
Timepoint
Intraoperative
Method of measurement
Time
Intervention groups
1
Description
Intervention group : Intravaginal Misoprostol ; 200mig 3 hourse before operation .
Category
Treatment - Drugs
2
Description
Control group : Intravaginal Vit B6 ( pelacebo ) 3 hourse before operation .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Women's Hospital
Full name of responsible person
Hajiha shima
Street address
Nejatollahi ave , Karimkhan ave , Tehran .
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research , Tehran University of Medical Sciences
Full name of responsible person
Hajiha shima
Street address
Nejatollahi ave , Karimkhan ave , Tehran .
City
Tehran
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 , Tehran 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
Tehran university of medical sciences
Full name of responsible person
Hajihashima
Position
Resident of Obstetrice & Gynecology
Other areas of specialty/work
Street address
Women's Hospital , Nejatollahi ave , Karimkhan ave , Tehran
City
Tehran
Postal code
Phone
+98 21 8831 3766
Fax
Email
Hajihashima@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr . Nasrin Niroomand
Position
Faculty member
Other areas of specialty/work
Street address
Women's Hospital , Nejatollahi ave , Karimkhan ave , Tehran
City
Tehran
Postal code
Phone
+98 21 8890 0002
Fax
Email
Hajihashima@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Hajiha shima
Position
Resident of Obstetrics & Gynecology
Other areas of specialty/work
Street address
Women's Hospital , Nejatollahi ave , Karimkhan ave , Tehran
City
Tehran
Postal code
Phone
+98 21 8831 3766
Fax
Email
Hajihashima@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)