The purpose of this study is comparing between use sub lingual misoprostol and blood loss during myomectomy.inclusion criteria: Over 18 years old; anemia due to AUB; uterine myoma under 8cm in sonography; were enrolled and exclusion criteria: known bleeding disease; active asthma; high diastolic blood pressure; recent NSAIDS use; known hepatic disease; severe anemia; allergy and recent received packed cell .This study is a double blind randomized clinical trial and all patients with uterine myoma in Gynecologic clinic of Rasool Akram Hospital from AUG 2013 to OCT 2014 were included. Sample size was 64 and participants were randomized into two intervention and control groups. In intervention group, patients received 200 micrograms sub lingual misoprostol 1 hour before surgery. Control group received placebo. We used basic hemoglobin and check hemoglobin after6, 24, 48 after surgery for assessing reduction of bleeding during surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014071414621N1
Registration date:2014-07-20, 1393/04/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-20, 1393/04/29
Registrant information
Name
Mansureh Vahdat
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 216659283
Email address
m-vahdat@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research-Iran University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between use sublingual misoprostol and blood loss during myomectomy
Public title
Comparison between use sublingual misoprostol and blood loss during myomectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Over 18 years old; anemia due to Abnormal uterine bleeding;uterine myoma under 8cm in sonography.
Exclusion criteria: known bleeding disease; active asthma; high diastolic blood pressure; recent NSAIDS use; known hepatic disease; severe anemia; allergy and recent received packed cell .
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
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
Iran University of Medical Sciences
Street address
Tehran-Hemmat highway-Central bilding of Iran University of Medical Sciences - Deputy of Research
City
Tehran
Postal code
Iran
Approval date
2014-07-14, 1393/04/23
Ethics committee reference number
93/105/1889 د
Health conditions studied
1
Description of health condition studied
Uterine myoma
ICD-10 code
N85.8
ICD-10 code description
Other specified noninflammatory disorders of uterus
Primary outcomes
1
Description
Bleeding
Timepoint
Preoparation,6 & 24& 48 hours after surgery
Method of measurement
Check of hemoglobin(CBC)
Secondary outcomes
empty
Intervention groups
1
Description
In treatment group 200 micrograms sub lingual misoprostol 1 hour before surgery
Category
Treatment - Drugs
2
Description
In control group placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Obstetrics and Gynecologic Department of Rasool akram Hospital
Full name of responsible person
Dr Sara Asadollah
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research- Iran University of Medical Sciences
Full name of responsible person
Deputy of Research-Iran University of Medical Sciences-Dr Mosavi
Street address
Tehran-Hemat highway- Deputy of Research
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research- Iran University of Medical Sciences