Evaluation of the Effects of Platelet-Rich Plasma (PRP) during cesarean section on the integrity and thickness of uterine scar
Design
This study is a parallel-group double-blind, randomized controlled trial.
Settings and conduct
The setting of study is two hospitals (Hazrat-e Rasool Akram and firooz Abadi) affiliated to Iran University of Medical of Science. Prior to the intervention informed written consent will be taken. 80 Pregnant women will be randomly divided into two groups (intervention and control) by using computer-generated table of random numbers. In the intervention group, PRP will be directly applied to the uterine myometrium tissue whereas the control group received the usual care.
Participants/Inclusion and exclusion criteria
Pregnant women who are undergoing cesarean section for the first time.
Inclusion criteria are:
Emergency and non-emergency cesarean section for the first time
Exclusion criteria will be:
Presence of uterine anomalies with or without previous repair
Presence of uterine myoma at the site of caesarean incision
History of myomectomy at site of caesarean incision
Presence of placenta previa and placenta accrete
Prolonged rupture of membranes without chorioamnionitis criteria (consist of fever, uterine tenderness…)
Rupture of membranes with chorioamnionitis criteria (consist of fever, uterine tenderness…)
Intervention groups
In the intervention group after the closure of the uterine myometrium incision, PRP will be directly applied to the uterine myometrium tissue whereas the control group received the usual care.
Main outcome variables
The primary outcomes are uterine closure time and primary postpartum hemorrhage. The secondary outcome is to compare the residual myometrial thickness and the depth of cesarean section scar defect after uterine incision closure using the new technique with the conventional technique.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190108042291N1
Registration date:2019-01-26, 1397/11/06
Registration timing:registered_while_recruiting
Last update:2019-01-26, 1397/11/06
Update count:0
Registration date
2019-01-26, 1397/11/06
Registrant information
Name
Shahla Mirgaloybayat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9283
Email address
mirgaloybayat.sh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effects of Platelet-Rich Plasma (PRP) during cesarean section on the integrity and thickness of uterine scar
Public title
The Effects of Platelet-Rich Plasma (PRP) during cesarean section on the integrity and thickness of uterine scar.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Emergency and non-emergency cesarean section for the first time
Exclusion criteria:
Presence of uterine anomalies with or without previous repair
Presence of uterine myoma at the site of caesarean incision
History of myomectomy at site of caesarean incision
Presence of placenta previa and placenta accrete
Prolonged rupture of membranes without chorioamnionitis criteria (consist of fever, uterine tenderness…)
Rupture of membranes with chorioamnionitis criteria (consist of fever, uterine tenderness…)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 80 pregnant women will be divided into two groups of 40 each using a computer-generated table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blinding (blinding participants, and investigators consisting of statistician and specialist in sonography) will be used to reduce the selection bias.
Placebo
Not 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 Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-11-14, 1397/08/23
Ethics committee reference number
IR.IUMS.REC.1397.477
Health conditions studied
1
Description of health condition studied
Cesarean section surgery
ICD-10 code
O82.9
ICD-10 code description
Delivery by caesarean section, unspecified
Primary outcomes
1
Description
Uterine closure time
Timepoint
During the surgery
Method of measurement
Chronometer
2
Description
Primary postpartum hemorrhage
Timepoint
During and the day after surgery
Method of measurement
Complete Blood Count(CBC)
3
Description
Pain
Timepoint
The day, week and month after surgery
Method of measurement
VAS scale
4
Description
Infection rate
Timepoint
The day, week and month after surgery
Method of measurement
Thermometer
Secondary outcomes
1
Description
Residual myometrial thickness
Timepoint
3 months after the surgery
Method of measurement
Ultrasound examination will be performed 3 months after the operation to assess the integrity of scar by measuring the residual myometrial thickness and the depth of the possible scar defect.
2
Description
The depth of cesarean section scar defect(thickness)
Timepoint
3 months after the surgery
Method of measurement
Ultrasound examination will be performed 3 months after the operation to assess the integrity of scar by measuring the residual myometrial thickness and the depth of the possible scar defect.
Intervention groups
1
Description
Intervention group: In this group, after the closure of the uterine myometrium incision, PRP will be directly applied to the uterine myometrium tissue whereas the control group received the usual care. PRP solution will be prepared based on the following steps: 1. Venous blood (30mL) will be drawn from the patient’s arm in anticoagulant-containing tubes; (the recommended temperature during processing is 21℃–24℃ to prevent platelet activation during centrifugation of the blood); 2. The blood will be centrifuged at 1,200 rpm for 12 minutes; 3. The blood separates into three layers: an upper layer that contains platelets and white blood cells, an intermediate thin layer (the buffy coat) that is rich in white blood cells, and a bottom layer that contains red blood cells; 4. The upper and intermediate buffy layers will be transferred to an empty sterile tube. The plasma will be centrifuged again at 3,300 rpm for 7 minutes to help with the formation of soft pellets (erythrocytes and platelets) at the bottom of the tube; 5. The upper two-thirds of the plasma will be discarded because it is platelet-poor plasma.6. Pellets are homogenized in the lower third (5 mL) of the plasma to create the PRP; the PRP will be ready for injection. Approximately 30 mL of venous blood yields 3–5 mL of PRP.7. The prepared PRP solution will be transferred within sterile syringe from the laboratory to the OR 8. Then will be directly applied to the uterine myometrium tissue before skin closure. 9. The patients were examined by the physician on day one, day seven and at day 30 after the procedure.
Category
Treatment - Surgery
2
Description
Control group: In control group cesarean section incision will be closed by the conventional technique(without PRP injection).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Shahla Mirgaloybayat
Street address
Rasoul Akram Hospital, Satarkhan St, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6435 2680
Email
mirgaloybayat.sh@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vice Chancellor for Administration of Iran University of Medical Sciences (IUMS)
Street address
Iran University of Medical Sciences, Hemmat freeway, next to Milad tower, Tehran.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
PR@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
Shahla Mirgaloybayat
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul Akram Hospital, Satarkhan St, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2680
Email
mirgaloybayat.sh@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shahla Mirgaloybayat
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul Akram Hospital, Satarkhan St, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2680
Email
mirgaloybayat.sh@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shahla Mirgalobayat
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul Akram Hospital, Satarkhan St, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2680
Email
mirgaloybayat.sh@iums.ac.ir
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
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
There is a plan to make this available.
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Data will be available for all researchers
Under which criteria data/document could be used
limitless
From where data/document is obtainable
For receiving data please be contacted with mirgaloybayat.sh@iums.ac.ir
What processes are involved for a request to access data/document