Protocol summary

Study aim
Determining the effect of the method of transamic acid use and position on cesarean section bleeding rate, surgical team satisfaction and postoperative complications.
Design
Clinical trial with control group, randomized, phase 3 on 102 patients. Blocking was used for randomization
Settings and conduct
Intervention group A is the injection of transzymic acid, which in cesarean surgery, after the birth of the baby and the removal of the placenta, one gram of transzymic acid will be injected intravenously.Intervention group B, application of reverse Trendelenberg position with 10 degrees and left tilt position with 15 degrees) after general anesthesia (before the birth of the baby), the bed position will be changed to reverse Trendelenberg position with 10 degrees.Group C: the group without routine intervention. This study will be conducted in Shahada Kargar Hospital in Yazd in 1403.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: Term women who are candidates for cesarean surgery, not suffering from coagulation and bleeding disorders, not suffering from liver and kidney diseases, no history of thromboembolism, history of singletons, no history of polyhydramnios, oligohydramnios (hemoglobin level 10-15 mg/d and platelets <100 thousand) Exclusion criteria include:Diagnosis of placental abruption, placental abruption, placenta accreta, uterine atony, intra-abdominal adhesions during operation, bladder, bowel and other internal organs damage during operation, uterine incision expansion and spinal anesthesia during operations.
Intervention groups
Group A: injection of transamic acid drug, group B: application of positions (inverted Trendelenberg position 10 degrees and left tilt position 15 degrees) and group C: group without intervention
Main outcome variables
Cesarean section bleeding - satisfaction of the surgical team - shoulder pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240421061546N1
Registration date: 2024-06-22, 1403/04/02
Registration timing: registered_while_recruiting

Last update: 2024-06-22, 1403/04/02
Update count: 0
Registration date
2024-06-22, 1403/04/02
Registrant information
Name
Elham Dehghanniri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3725 0742
Email address
elhamdehghanniri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-28, 1403/03/08
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of using transamic acid and position on Caesarean section bleeding rate, Surgical team satisfaction and postoperative complications.
Public title
Comparison between the effect of using transamic acid and position on Caesarean section bleeding rate, Surgical team satisfaction and postoperative complications.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Term women candidates for cesarean surgery Absence of bleeding coagulation disorders Absence of liver and kidney diseases No history of thromboembolism A history of singletons No history of polyhydramnios, oligohydramnios based on ultrasound Normal CBC (hemoglobin level 15-10 mg/d and platelets <100 thousand)
Exclusion criteria:
Dissatisfaction with continuing to participate in the study (during and after surgery) Placental abruption during cesarean section Acreta pair Polyhydramino Oligohydramnios uterine atony Intra-abdominal adhesions Bladder, intestine and other visceral damage during surgery Uterine dilatation Spinal anesthesia during surgery
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
The study groups are respectively: (Group A: group of injection of transamic acid drug, group B: change of position group (reverse Trendelenberg position 10 degrees and left tilt position of 15 degrees) and group C: control group, (group without intervention of transamic acid drug and position) ; for which six blocks are set, with 27 possible blocks (from number 1 to 27), randomly selected to complete the sample size of 15 blocks, and by determining the Master sheet and the envelopes The continuous list of patients from number 1 to 102 is indicated on the envelope and the type of intervention inside the envelope. The original list remains with the senior researcher.
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 Mazandaran University of Medical Sciences
Street address
Dormitory complex number one for girls, Mazandaran University of Medical Sciences (Prophet Azam Complex), Farah Abad Road, Sari
City
Sari
Province
Mazandaran
Postal code
4847193711
Approval date
2024-05-14, 1403/02/25
Ethics committee reference number
IR.MAZUMS.REC.1403.109

Health conditions studied

1

Description of health condition studied
Bleeding rate of cesarean section, surgical team satisfaction and postoperative complications.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Cesarean section bleeding
Timepoint
Registration of hemoglobin, hematocrit and platelets of the patient before the operation and 6 hours after the operation for all three groups
Method of measurement
Bleeding measurement rate: 1. Based on weighing of gas, lancet and suction volume 2. Satisfaction of the surgical team based on questionnaire 3. Registration of hemoglobin, hematocrit and platelets of the patient before the operation and 6 hours after the operation for all three groups

2

Description
Satisfaction of the surgical team
Timepoint
After cesarean section
Method of measurement
Based on the satisfaction questionnaire of the surgical team

Secondary outcomes

1

Description
shoulder pain
Timepoint
In the time period after the surgery in the recovery area of ​​the operating room and 24 hours after the surgery
Method of measurement
Visual-linear pain measurement scale (VAS)

Intervention groups

1

Description
Intervention group: Group: A is the transzymic acid injection group, in which one gram of transzymic acid will be injected intravenously in cesarean surgery, after the baby is born and the placenta is removed. Transamic acid drug is manufactured by Caspian Tamin Pharmaceutical factory in Iran.
Category
Prevention

2

Description
Intervention group: Group B: the group applying reverse Trendelenberg position with 10 degrees and left tilt position with 15 degrees) after general anesthesia (before the birth of the baby), the bed position is changed to reverse Trendelenberg position with 10 degrees. will be given.
Category
Prevention

3

Description
Group C: Control group, (group without routine intervention).
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada Kargar Hospital, Yazd
Full name of responsible person
Elham Dehghan Niri
Street address
Madras Blvd., Prayer Square
City
Yazd
Province
Yazd
Postal code
8915451135
Phone
+98 35 3182 2000
Fax
+98 35 3825 0007
Email
hospital.kargar@ gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Pedram Ebrahimnejad
Street address
Research and Technology Deputy Building, Moalem Square, Sari
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3325 7230
Fax
Email
pajhooheshi@muzums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Elham Dehghan Niri
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Montazeri Alley, Taleghani Boulevard, Azadi Square, Yazd
City
Yazd
Province
Yazd
Postal code
8916655894
Phone
+98 35 3725 0742
Email
elhamdehghanniri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Nasiri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Prophet Azam University Complex, Farah Abad Kilometer 17, Farah Abad Blvd (Darya Road), Khazar Square, Sari
City
Sari
Province
Mazandaran
Postal code
4847193711
Phone
+98 11 3354 3246
Email
Pirapezeshkisari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
ElhamDehghanniri
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Montazeri Alley, Azadi Square, Yazd
City
Yazd
Province
Yazd
Postal code
8916655894
Phone
+98 35 3725 0742
Email
elhamdehghanniri@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
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