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Effect of Autologous Platelet-rich Plasma in Uterine Wound Healing

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03497325
Enrollment
134
Registered
2018-04-13
Start date
2020-02-01
Completion date
2020-12-15
Last updated
2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications

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.

Interventions

DRUGautologus platelet rich plasma

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

DRUGplacebo

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Presence of cesarean scar defect(niche)12 weeks after CSany defect in the anterior myometrium related to scar site

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026