Comparison of the effect of prophylactic misoprostol versus tranexamic acid in reduction of postpartum hemorrhage in candidate patients for cesarean in Amir Al-Momenin hospital, Semnan.
Objectives: Considering the importance of postpartum hemorrhage and finding a way for lowering the complications of postpartum hemorrhage especially maternal mortality, this study is designed to compare the effect of misoprostol and tranexamic acid in reducing of postpartum hemorrhage.
Design: This study is blinded clinical trial and patients after informed consent will enrolled and divide into three groups.
Setting and conduct: Two hundred and eighty five patients who fulfill inclusion criteria will enroll in study after informed consent and will be randomly divided into three groups and interventions perform on them.
Participants and major inclusion and exclusion criteria: Pregnant women candidates for elective cesarean with gestational age 37 weeks or more, singleton pregnancy with cephalic presentation, will be enrolled. Patients with preeclampsia, multiple pregnancies, premature birth, prolonged rupture of the membranes, abnormal placental-binding, systemic diseases and sensitivity to prostaglandins are excluded.
Intervention: Cesarean section will done under spinal anesthesia. Group A will receive 400 micrograms of misoprostol rectal (as 2 tablets of 200 mcg) and group B receive Tranexamic acid, 10mg/kg 30 minutes before operation as intravenous infusion during 20 minutes.
Main outcome measures (variables): The main outcome is the amount of blood lost and hemoglobin and hematocrit values.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102511504N6
Registration date:2015-12-17, 1394/09/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-17, 1394/09/26
Registrant information
Name
Sanam Moradan
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1446 0066
Email address
smoradan@sem.ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Semnan University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of prophylactic misoprostol versus tranexamic acid in reduction of postpartum hemorrhage in candidate patients for cesarean in Amir Al-Momenin hospital, Semnan.
Public title
Effects of Misoprostol versus Tranexamic acid in reduction of postpartum hemorrhage after cesarean
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Candidates for elective cesarean section; gestational age 37 weeks or more; singleton pregnancy with cephalic presentation.
Exclusion criteria: Preeclampsia; multiple pregnancies; premature birth; prolonged rupture of the membranes; abnormal placental-binding; systemic diseases; sensitivity to prostaglandins.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
285
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Commettee of Semnan University of Medical Sicenses
Street address
Basidj Boulevard
City
Semnan
Postal code
3519747167
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.SEMUMS.REC.1394.75
Health conditions studied
1
Description of health condition studied
Postpartum hemorrhage
ICD-10 code
O72
ICD-10 code description
Postpartum haemorrhage
Primary outcomes
1
Description
Volume of Blood Loss
Timepoint
During surgery
Method of measurement
Measuring of blood lost and counting of blood soaked gauze pieces
Secondary outcomes
1
Description
Hematocrite and Hemoglubin
Timepoint
24 horses after surgery
Method of measurement
Laboratory test
Intervention groups
1
Description
Group A: Cesarean section will do under spinal anesthesia. Patients receive 400 micrograms of misoprostol rectal (as 2 tablets of 200 mcg).
Category
Treatment - Drugs
2
Description
Groupe B: Cesarean section will done under spinal anesthesia. Patients receive Tranexamic acid, 10mg/kg 30 minutes before operation as intravenous infusion during 20 minutes.
Category
Treatment - Drugs
3
Description
Group C: Cesarean section will do under spinal anesthesia. Patients will not receive any treatments except standard and usual therapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al Momenin hospital
Full name of responsible person
Roya Mahdavi Anaraki
Street address
Imam Hussein square
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Semnan University of Medical Science
Full name of responsible person
Mohammad Reza Asgari
Street address
Basidj Boulevard
City
Semnan
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 of Semnan University of Medical Science
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
Semnan University of Medical Sciences
Full name of responsible person
Dr. Roya Mahdavi Anaraki
Position
Obestetric and Gynecology Resident
Other areas of specialty/work
Street address
Imam Hussein square, Amir Al Momenin Hospital
City
Semnan
Postal code
3519734731
Phone
+98 23 3344 0066
Fax
Email
maryamsina1234@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Science
Full name of responsible person
Dr. Sanam Moradan
Position
Gynecologist/ Associate professor
Other areas of specialty/work
Street address
Amir Al Momenin Hospital, Imam Hussein Square
City
Semnan
Postal code
3519734731
Phone
+98 23 3344 0066
Fax
Email
smoradan@semums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Research Expert
Other areas of specialty/work
Street address
Kowsar Hospital, Amin Avenue, Basidj Bulvard
City
Semnan
Postal code
3519899951
Phone
+98 23 3343 7838
Fax
Email
mehrdadzahmatkesh@semums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)