PRP Use in Diabetic Patients Undergoing Cesarean Section

Minia University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Diabetes, Gestational; Wound Complication

Treatments: Biological: PRP

Study type: Interventional

Funder types: Other

Identifiers

NCT03602950

MiniaU2018

Details and patient eligibility

About

this study will investigate the effectiveness of PRP in wound healing among diabetic patients undergoing elective cesarean sections

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control group

No Intervention group

Description:

50 diabetic ladies at full term will undergo elective CS and will receive the usual surgical care routinely done at our hospital

study group

Active Comparator group

Description:

50 diabetic ladies will undergo elective CS at full term and autologous PRP will be injected subcutaneously before skin closure.

Treatment:

Biological: PRP