Effect of Autologous Platelet-rich Plasma in Uterine Wound Healing

• ClinicalTrials.gov Identifier: NCT03497325
• Recruitment Status: Completed
• First Posted: April 13, 2018
• Last Update Posted: July 21, 2021
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): Radwa Rasheedy Ali, Ain Shams University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Cesarean Section Complications	Drug: autologus platelet rich plasma; Drug: placebo	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 134 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: the Efficacy of Intramuscular Autologous Platelet-rich Plasma Injection on Uterine Wound Healing After Primary Cesarean Section
• Actual Study Start Date: February 1, 2020
• Actual Primary Completion Date: December 15, 2020
• Actual Study Completion Date: December 15, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: PRP; 55 participant unergoing prelabor primary CS will receive intramyometrial injection of PRP after closure of uterine incision	Drug: autologus platelet rich plasma; 55 participant unergoing prelabor primary CS will receive intramyometrial injection of PRP after closure of uterine incision
Placebo Comparator: placebo; 55 participant unergoing prelabor primary CS will receive intramyometrial injection of normal saline after closure of uterine incision	Drug: placebo; 55 participant unergoing prelabor primary CS will receive intramyometrial injection of normal saline after closure of uterine incision

Outcome Measures

Primary Outcome Measures :

1. Presence of cesarean scar defect(niche) [ Time Frame: 12 weeks after CS ]
   any defect in the anterior myometrium related to scar site

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Egypt

Ain Shams university maternity hospital

Cairo, Egypt

Sponsors and Collaborators

Ain Shams University

More Information

• Responsible Party: Radwa Rasheedy Ali, lecturer, Ain Shams University
• ClinicalTrials.gov Identifier: NCT03497325
• Other Study ID Numbers: ASUM hospital
• First Posted: April 13, 2018
• Last Update Posted: July 21, 2021
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No