PRP Use in Diabetic Patients Undergoing Cesarean Section

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-02-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Diabetes, Gestational Wound Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

study group

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

Group Type ACTIVE_COMPARATOR

PRP

Intervention Type BIOLOGICAL

autologous PRP will be injected subcutaneously before skin closure at time of elective CS

Interventions

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PRP

autologous PRP will be injected subcutaneously before skin closure at time of elective CS

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No