Investigation the effect of rectal misoprostol before and after cesarean section on the amount of bleeding after the surgery
Design
In this study 120 pregnant women candidate for elective cesarean section will be included in the study and after inclusion will be non randomly assigned into tow groups; before surgery group and after surgery group.
Settings and conduct
In all patients, after inclusion in the study, the hemoglobin level will be measured. In the group receiving misoprostol before the study, this drug will be used rectally just before skin incision and in the group receiving misoprostol this drug will be used rectally just after the end of cesarean section and closing the abdomen wound. In both groups the number of bloody guazes and the amount of blood in suction set and also the hemoglobin level will be determined. At the end of the study the amount of blood loss and decline in hemoglobin level will be compared together.
Participants/Inclusion and exclusion criteria
Inclusion criterion: all the term pregnant women candidate for elective cesarean section
Exclusion criteria: placenta previa; diabetes mellitus; active labor; using anti-coagulant drugs; contraindication for using misoprostol.
Intervention groups
A group receiving misoprostal before cesarean: will receive one rectal misoprostol suppository just before cesarean section.
A group receiving misoprostal after cesarean:will receive one rectal misoprostol suppository just after cesarean section.
Main outcome variables
Amount of blood loss
Amount hemoglobin level decline
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180107038254N1
Registration date:2018-02-05, 1396/11/16
Registration timing:registered_while_recruiting
Last update:2018-02-05, 1396/11/16
Update count:0
Registration date
2018-02-05, 1396/11/16
Registrant information
Name
Azam Sharafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5715
Email address
azam.sharafi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of rectal misoprostol before and after cesarean section on the amount of bleeding after the surgery
Public title
The effect of misoprostol on the amount of bleeding in cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All full-term pregnant women candidate for elective cesarean section
Exclusion criteria:
Placenta previa
Diabetes mellitus
Active labor
Using anti-coagulant drugs
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Zahedan University of Medical Sciences
Street address
Ethics committee of Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Approval date
2017-06-25, 1396/04/04
Ethics committee reference number
IR.ZAUMS.REC.1396. 29
Health conditions studied
1
Description of health condition studied
Cesarean section
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hemoglobin level
Timepoint
Before and after cesarean section
Method of measurement
Measured by laboratory
2
Description
Amount of blood loss
Timepoint
During cesarean section
Method of measurement
By measuring the amount of blood in suction set and the number of bloody guazes
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: in this group the patients will receive 2 200 mcg rectal misoprostol suppositories from Samisaz pharmaceutical company just before making the abdominal skin incision.
Category
Prevention
2
Description
Second Intervention group: in this group the patients will receive 2 200 mcg rectal misoprostol suppositories from Samisaz pharmaceutical company just after closing the abdominal wall.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abi Taleb Hospital
Full name of responsible person
Aezam Sharafi
Street address
Khalije Fars Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
aezam.sharafi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hooshang Rafighdoost
Street address
Vice chancellor for research, Zahedan University of Medical Sciences campus, Jannat Blvd, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
h.rafighdoost@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Aezam Sharafi
Position
Gynecology resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
aezam.sharafi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Aezam Sharafi
Position
Gynecology resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
aezam.sharafi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Aezam Sharafi
Position
Gynecology resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
aezam.sharafi@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
There is no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available