Effect of Autologous Platelet-rich Plasma in Uterine Wound Healing

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2020-12-15

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

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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.

Conditions

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Cesarean Section Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PRP

55 participant unergoing prelabor primary CS will receive intramyometrial injection of PRP after closure of uterine incision

Group Type EXPERIMENTAL

autologus platelet rich plasma

Intervention Type DRUG

55 participant unergoing prelabor primary CS will receive intramyometrial injection of PRP after closure of uterine incision

placebo

55 participant unergoing prelabor primary CS will receive intramyometrial injection of normal saline after closure of uterine incision

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

55 participant unergoing prelabor primary CS will receive intramyometrial injection of normal saline after closure of uterine incision

Interventions

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autologus platelet rich plasma

55 participant unergoing prelabor primary CS will receive intramyometrial injection of PRP after closure of uterine incision

Intervention Type DRUG

placebo

55 participant unergoing prelabor primary CS will receive intramyometrial injection of normal saline after closure of uterine incision

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No