Effect of Autologous Platelet-rich Plasma in Uterine Wound Healing

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03497325
• Other study ID #: ASUM hospital
• Status: Completed
• Phase: Phase 2
• Start date: February 1, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: July 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Drug:
• autologus platelet rich plasma
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

Locations

Country	Name	City	State
Egypt	Ain Shams university maternity hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of cesarean scar defect(niche)	any defect in the anterior myometrium related to scar site	12 weeks after CS