Determining the effect of a single preoperative dose of sublingual Misoprostol on intraoperative blood loss during total abdominal hysterectomy.
Design
Randomized clinical trial, with control group, two arm parallel group, double blind, 3th phase.
Settings and conduct
The study population include women who were nominated for abdominal hysterectomy due to benign gynecologic diseases in the Rasool Akram and Firoozgar Hospitals in Tehran.
In this double-blind randomized clinical trial, surgeons and patients are blinded about the administered tablets (misoprostol or vitamin B6).
Participants/Inclusion and exclusion criteria
Inclusion criteria:nominated patient for abdominal hysterectomy due to benign gynecologic disease
Exclusion criteria:contraindication for misoprostol and malignant disease
Intervention groups
In the intervention group, 1 tablets of misoprostol 200 μg and in the control group (placebo) 1 tablets of vitamin B6 40 mg are administered sublingually one hour before surgery.
Main outcome variables
The amount of bleeding during surgery; post-operation hemoglobin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180821040844N1
Registration date:2018-12-06, 1397/09/15
Registration timing:retrospective
Last update:2018-12-06, 1397/09/15
Update count:0
Registration date
2018-12-06, 1397/09/15
Registrant information
Name
Vahideh Astaraei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3879 5777
Email address
vahideh.astaraei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
2017-11-22, 1396/09/01
Actual recruitment end date
2018-05-05, 1397/02/15
Trial completion date
2018-05-05, 1397/02/15
Scientific title
Effect of a Single Preoperative Dose of Sublingual Misoprostol on Intraoperative Blood Loss During Total Abdominal Hysterectomy
Public title
Effect of a Single Preoperative Dose of Sublingual Misoprostol on Intraoperative Blood Loss During Total Abdominal Hysterectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient who were Nominated for Abdominal Hysterectomy due to Benign Gynecologic Disease
Patients are assigned to intervention and control groups, using random sequences generated by SPSS software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Surgeons and patients will be blind about the administered tablets (misoprostol or vitamin B6).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Science
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶-۱۴۵۳۵
Approval date
2018-04-07, 1397/01/18
Ethics committee reference number
IR.IUMS.FMD.REC1396.9311290001
Health conditions studied
1
Description of health condition studied
Bleeding during hysterectomy
ICD-10 code
N99
ICD-10 code description
Intraoperative and postprocedural complications and disorders of genitourinary system, not elsewhere classified
Primary outcomes
1
Description
ُThe amount of bleeding during surgery.
Timepoint
during surgery (from incision until suturing) and immediately after surgery.
Method of measurement
Sum of the measuring the suctioned blood with the absorbed blood in sterile gauzes (assessing the weight difference between bloody gauzes and dry ones)
Secondary outcomes
1
Description
Post-operation hemoglobin
Timepoint
24 hours after surgery
Method of measurement
Blood sample (g/dl)
Intervention groups
1
Description
Intervention group: one tablets of misoprostol (200 μg) were administered sublingually one hour before surgery.
Category
Prevention
2
Description
Control group: One tablets of vitamin B6 (40 mg) were administered sublingually one hour before surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram and Firoozgar Hospitals of Tehran
Full name of responsible person
Vahideh Astaraei
Street address
Rasool Akram and Firoozgar Hospitals,Maziar Mansuri Ave., Satar Khan Ave.,
City
Tehran
Province
Tehran
Postal code
98888678881
Phone
+98 21 8364 3512
Fax
Email
Vahideh.astaraei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Morteza Naserbakht
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vahideh Astaraei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vali-e-asr square, Karim Khan Zand street, Beh Afarin street
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1201
Email
vahideh.astaraei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vahideh Astaraei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vali-e-asr square, Karim Khan Zand street, Beh Afarin street
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1201
Email
vahideh.astaraei@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vahideh Astaraei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vali-e-asr square, Karim Khan Zand street, Beh Afarin street
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1201
Email
vahideh.astaraei@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD