Effect of Autologous Platelet-rich Plasma in Uterine Wound Healing

July 15, 2021 updated by: Radwa Rasheedy Ali, Ain Shams University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

134

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of cesarean scar defect(niche)
Time Frame: 12 weeks after CS
any defect in the anterior myometrium related to scar site
12 weeks after CS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

December 15, 2020

Study Completion (Actual)

December 15, 2020

Study Registration Dates

First Submitted

April 6, 2018

First Submitted That Met QC Criteria

April 11, 2018

First Posted (Actual)

April 13, 2018

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 15, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • ASUM hospital

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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