- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03602950
PRP Use in Diabetic Patients Undergoing Cesarean Section
July 26, 2018 updated by: Hany Hassan Kamel, Minia University
Role of Autologous Platelet-Rich Plasma Solution in Wound Healing in Diabetic Patients Undergoing Elective Cesarean Delivery
this study will investigate the effectiveness of PRP in wound healing among diabetic patients undergoing elective cesarean sections
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
50 diabetic ladies at full term will undergo elective CS and will receive the usual surgical care routinely done at our hospital
|
|
Active Comparator: study group
50 diabetic ladies will undergo elective CS at full term and autologous PRP will be injected subcutaneously before skin closure.
|
autologous PRP will be injected subcutaneously before skin closure at time of elective CS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in wound healing
Time Frame: one week post-operatively
|
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
|
one week post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
morbidly wound healing
Time Frame: 4-8weeks
|
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
|
4-8weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2018
Primary Completion (Anticipated)
February 28, 2019
Study Completion (Anticipated)
February 28, 2019
Study Registration Dates
First Submitted
July 6, 2018
First Submitted That Met QC Criteria
July 26, 2018
First Posted (Actual)
July 27, 2018
Study Record Updates
Last Update Posted (Actual)
July 27, 2018
Last Update Submitted That Met QC Criteria
July 26, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MiniaU2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes, Gestational
-
IRCCS Burlo GarofoloCompletedGestational Diabetes | Gestational Diabetes Mellitus | Pregnancy-Induced Diabetes | Diabetes Mellitus, Gestational | Diabetes, Pregnancy InducedIsrael, Italy, Netherlands, Slovenia, Sri Lanka
-
UPECLIN HC FM Botucatu UnespCompletedGestational Diabetes Mellitus | Pregestational Diabetes Mellitus | Mild Gestational HyperglycemiaBrazil
-
Assistance Publique - Hôpitaux de ParisCompleted
-
University of Texas Southwestern Medical CenterCompletedMild Gestational DiabetesUnited States
-
Royal College of Surgeons, IrelandHealth Research Board, IrelandUnknownPre-Gestational Diabetes
-
University of Colorado, DenverKaiser PermanenteCompletedGestational Diabetes MellitusUnited States
-
Intermountain Health Care, Inc.Withdrawn
-
Baylor College of MedicineRecruitingGestational Diabetes MellitusUnited States
-
Joslin Diabetes CenterRoche DiagnosticsCompletedGestational Diabetes MellitusUnited States
-
Ludwig-Maximilians - University of MunichGerman Federal Ministry of Education and Research; Helmholtz Zentrum MünchenCompletedGestational Diabetes MellitusGermany
Clinical Trials on PRP
-
Sun Yat-sen UniversityUnknownSevere Non-proliferative Diabetic RetinopathyChina
-
Ankara Universitesi TeknokentCompleted
-
National Defense Medical Center, TaiwanTri-Service General HospitalRecruitingAnkle Sprain 2Nd Degree | Ankle Sprain 3Rd DegreeTaiwan
-
Postgraduate Institute of Dental Sciences RohtakUnknownPeriapical Lesions
-
Cairo UniversityRecruiting
-
University of Colorado, DenverTerumo BCTCompletedOsteochondritis DissecansUnited States
-
Fondazione Policlinico Universitario Agostino Gemelli...RecruitingDry Age-related Macular DegenerationItaly
-
Yantai Yuhuangding HospitalRecruitingKnee OsteoarthritisChina
-
Yantai Yuhuangding HospitalTerminated
-
Anita Syla LokajEnrolling by invitation