Effect of Autologous Platelet-rich Plasma in Uterine Wound Healing

Ain Shams University

Status and phase: Completed; Phase 2

Conditions: Cesarean Section Complications

Treatments: Drug: placebo; Drug: autologus platelet rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT03497325

ASUM hospital

Details and patient eligibility

About

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

Full description

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.

Enrollment: 134 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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134 participants in 2 patient groups, including a placebo group

PRP

Experimental group

Description:

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

Treatment:

Drug: autologus platelet rich plasma

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo