Effect of Autologous Platelet-rich Plasma in Uterine Wound Healing

Study Overview
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Brief Summary
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The aim of this study is to evaluate the efficacy of intramuscular autologus platelet rich plasma on uterine wound healing after primary cesarean section

Detailed Description
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110 pregnant female undergoing primary prelabor CS will be randomized to two groups group A)autologus PRP will be prepared from participant venous blood collected from the participants' arm into a syringe primed with ACD-A. then it will be injected into uterus after closing uterine incision . Injection sites will be selected near the incision at evenly 20 different sites group B)normal saline 0.9 will be injected into uterus after closing uterine incision . Injection sites will be selected near the incision at evenly 20 different sites.

Official Title
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the Efficacy of Intramuscular Autologous Platelet-rich Plasma Injection on Uterine Wound Healing After Primary Cesarean Section

Conditions
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Cesarean Section Complications

Intervention / Treatment
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* Drug: autologus platelet rich plasma
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Term pregnancy (gestational age between 37-41 weeks). Women undergoing cesarean section for the first time. Normal vaginal ultrasound examination and exclusion of any pelvic abnormality. Uncomplicated cesarean section. Lower uterine segment cesarean sections while the women not in labor Exclusion Criteria: Women with complications during or after cesarean section as intrapartum or postpartum hemorrhage, puerperal sepsis, septic wound Women with medical diseases that can affect the healing as diabetes mellitus, anemia, chronic renal disease or hepatic disease or coagulopathy or receiving medications affect wound healing as corticosteroids or anticoagulant. Women who will use intrauterine device as a contraceptive method Women with uterine abnormality as cervical stenosis or fibroid uterus multiple gestation, placenta abruption, placenta previa, antepartum hemorrhage prolonged ROM, chorioamnionitis,meconium stained liquor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP<br>55 participant unergoing prelabor primary CS will receive intramyometrial injection of PRP after closure of uterine incision | Drug: autologus platelet rich plasma<br>* 55 participant unergoing prelabor primary CS will receive intramyometrial injection of PRP after closure of uterine incision<br>|
| Placebo Comparator: placebo<br>55 participant unergoing prelabor primary CS will receive intramyometrial injection of normal saline after closure of uterine incision | Drug: placebo<br>* 55 participant unergoing prelabor primary CS will receive intramyometrial injection of normal saline after closure of uterine incision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of cesarean scar defect(niche) | any defect in the anterior myometrium related to scar site | 12 weeks after CS |