Back to resultsPRP Use in Diabetic Patients Undergoing Cesarean Section
Primary Purpose
Diabetes, Gestational, Wound Complication
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
PRP
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes, Gestational
Eligibility Criteria
Inclusion Criteria:
- The inclusion criteria will be a fixed factor along with age(18 y:45 y),diabetic patients(any type of diabetes),elective delivery,average body mass index(BMI) (17 : 24.9),Non previously scared uterus ,single pregnancy
Exclusion Criteria:
- The exclusion criteria will be younger ages below 18 years ,older ages above 45 years, emergency caesarean delivery, previous scared uterus, underweight BMI below 17, overweight BMI above 24.9, no other medical problems, associated other diseases, and multiple pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control group
study group
Arm Description
50 diabetic ladies at full term will undergo elective CS and will receive the usual surgical care routinely done at our hospital
50 diabetic ladies will undergo elective CS at full term and autologous PRP will be injected subcutaneously before skin closure.
Outcomes
Primary Outcome Measures
changes in wound healing
REEDA descriptive scale will assess degree of wound healing which formed of 4 points in a categorical score assessing 5 items of healing, redness, edema,ecchymosis,discharge ,approximation of the wound edges. each item is rated on a scale of 0-3 and total score may range between 0-15. lower scores indicating good healing
Secondary Outcome Measures
morbidly wound healing
at 4 and 8 weeks post-operatively the wound healing will be completed and will be assessed using VSS,Vancouver scar scale, which detect formation of keloid or hypertrophic scars. it will assess vascularity, scar thickness, pliability and pigmentation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03602950
Brief Title
PRP Use in Diabetic Patients Undergoing Cesarean Section
Official Title
Role of Autologous Platelet-Rich Plasma Solution in Wound Healing in Diabetic Patients Undergoing Elective Cesarean Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Anticipated)
Primary Completion Date
February 28, 2019 (Anticipated)
Study Completion Date
February 28, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
this study will investigate the effectiveness of PRP in wound healing among diabetic patients undergoing elective cesarean sections
Detailed Description
In this balanced, randomized, and controlled prospective study, 100 pregnant ladies at full term diabetic patients will be admitted to Minia University hospital. The patients will be randomly assigned into two groups. The intervention group will receive PRP at surgery, whereas the control group will receive the usual care. All patients will be evaluated at baseline, one week, two weeks, four weeks and eight week after the cesarean section.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Gestational, Wound Complication
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The intervention group will receive PRP at surgery, whereas the control group will receive the usual care. All patients will be evaluated at baseline, one week, four weeks and eight week after the cesarean section.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
50 diabetic ladies at full term will undergo elective CS and will receive the usual surgical care routinely done at our hospital
Arm Title
study group
Arm Type
Active Comparator
Arm Description
50 diabetic ladies will undergo elective CS at full term and autologous PRP will be injected subcutaneously before skin closure.
Intervention Type
Biological
Intervention Name(s)
PRP
Intervention Description
autologous PRP will be injected subcutaneously before skin closure at time of elective CS
Primary Outcome Measure Information:
Title
changes in wound healing
Description
REEDA descriptive scale will assess degree of wound healing which formed of 4 points in a categorical score assessing 5 items of healing, redness, edema,ecchymosis,discharge ,approximation of the wound edges. each item is rated on a scale of 0-3 and total score may range between 0-15. lower scores indicating good healing
Time Frame
one week post-operatively
Secondary Outcome Measure Information:
Title
morbidly wound healing
Description
at 4 and 8 weeks post-operatively the wound healing will be completed and will be assessed using VSS,Vancouver scar scale, which detect formation of keloid or hypertrophic scars. it will assess vascularity, scar thickness, pliability and pigmentation
Time Frame
4-8weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnancy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria will be a fixed factor along with age(18 y:45 y),diabetic patients(any type of diabetes),elective delivery,average body mass index(BMI) (17 : 24.9),Non previously scared uterus ,single pregnancy
Exclusion Criteria:
The exclusion criteria will be younger ages below 18 years ,older ages above 45 years, emergency caesarean delivery, previous scared uterus, underweight BMI below 17, overweight BMI above 24.9, no other medical problems, associated other diseases, and multiple pregnancy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PRP Use in Diabetic Patients Undergoing Cesarean Section
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