Effect of Autologous Platelet-rich Plasma in Uterine Wound Healing

Phase 2

Completed

• Conditions: Cesarean Section Complications
• Interventions: Drug: placebo; Drug: autologus platelet rich plasma

• Registration Number: NCT03497325
• Lead Sponsor: Ain Shams University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-04-06
• Study First Submitted QC: 2018-04-11
• Study First Posted: 2018-04-13
• Study Start: 2020-02-01
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-15
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 134

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	55 participant unergoing prelabor primary CS will receive intramyometrial injection of normal saline after closure of uterine incision
PRP	autologus platelet rich plasma	55 participant unergoing prelabor primary CS will receive intramyometrial injection of PRP after closure of uterine incision

Primary Outcome Measures

Name	Time	Method
Presence of cesarean scar defect(niche)	12 weeks after CS	any defect in the anterior myometrium related to scar site

Trial Locations

Locations (1)

Ain Shams university maternity hospital; 🇪🇬 Cairo, Egypt