Platelet Rich Plasma for Uterine Scar (AA-PRP)

May 18, 2023 updated by: Aya Mohr Sasson, The University of Texas Health Science Center, Houston

Platelet Rich Plasma for the Treatment of Uterine Scar

When vessel wall injury occurs, platelets become activated, releasing more than 30 bioactive proteins, many of which have a fundamental role in hemostasis, inflammation and ultimate wound healing. Platelet-rich plasma (PRP), a modification of fibrin glue made from autologous blood, is being used to deliver growth factors in high concentration to sites requiring wound healing. PRP is obtained from a sample of patients' blood drawn at the time of treatment. As the rate of cesarean deliveries has been rising, long-term adverse sequelae due to uterine scar defects have been increasing. PRP might be a simple preventive treatment that potentially can reduce morbidity following cesarean deliveries.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction Platelets are cytoplasmic fragments of megakaryocytes, formed in the marrow and approximately 2 μm in diameter. When vessel wall injury occurs, they become activated, releasing more than 30 bioactive proteins, many of which have a fundamental role in hemostasis, inflammation and ultimate wound healing. Growth factors released from the platelets include platelet-derived growth factor, transforming growth factor beta, platelet-derived epidermal growth factor, platelet-derived angiogenesis factor, insulin-like growth factor 1, and platelet factor 4. These factors signal the local mesenchymal and epithelial cells to migrate, divide, and increase collagen and matrix synthesis.

Platelet-rich plasma (PRP), a modification of fibrin glue made from autologous blood, is being used to deliver growth factors in high concentration to sites requiring wound healing. Its clinical uses have dramatically increased in the last decade in various fields of medicine including orthopedics, cardiothoracic surgery, plastic surgery, dermatology, dentistry, and diabetic wound healing. Recently, its positive effects in promoting endometrial and follicular growth and gestation in assisted reproduction cycles have also been demonstrated.

PRP is obtained from a sample of patients' blood drawn at the time of treatment. A 30cc venous blood draw will yield 3-5 cc of PRP depending on the baseline platelet count of an individual, the device used, and the technique employed. The blood draw occurs with the addition of an anticoagulant, such as citrate dextrose A to prevent platelet activation prior to its use. The preparation process is known as differential centrifugation. An initial centrifugation to separate red blood cells (RBC) is followed by a second centrifugation to concentrate platelets, which are suspended in the smallest final plasma volume. The upper 2/3 portion of the volume that is composed mostly of platelet-poor plasma (PPP) is removed. Pellets are homogenized in lower 1/3rd (5 ml of plasma) to create the Platelet-Rich Plasma (PRP). A count of 1 million /mL has become the working definition for therapeutic PRP. Activation of the platelets before their application is not required as there is no consensus for better results.

Caesarean delivery is the commonest operation performed on women worldwide with progressively rising incidence. Consequently, long-term adverse sequelae due to uterine scar defect have been increasing. Common gynecological complains include chronic pelvic pain, dyspareunia, dysmenorrhea and postmenstrual spotting and infertility. Obstetric sequelae seem to be increasing such as cesarean scar ectopic pregnancy, placenta previa, and placenta accrete, all associated with major maternal morbidity and even mortality. Given the association between uterine scar defect and gynecological symptoms, obstetric complications and potentially subfertility, it is important to develop preventive strategies.

To the best of knowledge studies using PRP for uterine scars treatment have not been published. Due to the aforementioned, the aim of our study is to learn the effect of PRP use on uterine scar healing.

Material and Methods This is a prospective randomized single blinded study that will be conducted in a single tertiary medical center. Study population will include: A. women planned to undergo elective cesarean delivery at term with singleton pregnancy; and B. women undergoing uterine scar repair due to uterine scar defect following cesarean delivery. Women meeting inclusion criteria will be offered to participate in the study. After signing informed consent, block randomization will be separately completed for each study population for one of two groups: A- administration of PRP following uterine incision repair, B - no administration of PRP on the uterine incision. Women will be blinded to the group they have been randomized to. Blood will be drawn to all women 30 minutes before operation for platelet count and preparation of PRP (in case randomization was for group A). All operations will be performed by highly skilled surgeons of the same team. All other stages of operations will be similar in both of the groups. Operative and post-operative data will be collected from the medical files including: operation duration, estimated blood loss, operation complications (hypotension, bladder gut or vascular perforation), post-operative complications (hemorrhage, endometritis, vascular - thromboembolic event, ileus). All women will be invited to the gynecologic clinics six months post operation for trans-vaginal sonographic evaluation of the uterine scar. Measurement will include uterine scar residual myometrial thickness (RMT), adjacent myometrial thickness (AMT), depth, length, and RMT/AMT ratio.

Women's reports regarding possibility of uterine scar defect symptoms (heavy menstrual bleeding, intermenstrual spotting, pelvic pain) will additionally be collected on follow-up visit

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

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

18 years to 52 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

Study group A:

  • Women undergoing elective cesarean delivery
  • Term pregnancy (≥37 weeks of gestation)
  • Singleton pregnancy

Study group B:

- Women undergoing niche (uterine scar defect) repair

Exclusion criteria:

  • Thrombocytopenia (CBC Platelet count <70,000)
  • Connective tissue disease
  • Uterine scars other than cesarean (s/p myomectomy, s/p cornual resection)
  • Malformed uterus (unicornuate, bicornuate, didelphic)
  • Pregnancy

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRP Treatment
PRP preparation will be applied on uterine incision after its closure.
Other: Platelet Rich Plasma
Applying 5cc of PRP preparation on uterine incision after it has been sutured.
No Intervention: Control
Normal Cesarean delivery stages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual myometrial thickness
Time Frame: 6 months after cesarean delivery
Residual myometrial thickness at the uterine scar (mm)
6 months after cesarean delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual myometrial thickness/Adjacent myometrial thickness
Time Frame: 6 months after cesarean delivery
Ratio between adjacent and residual myometrial thickness
6 months after cesarean delivery
Niche depth
Time Frame: 6 months after cesarean delivery
Niche depth (mm)
6 months after cesarean delivery
Niche length
Time Frame: 6 months after cesarean delivery
Niche length (mm)
6 months after cesarean delivery

Collaborators and Investigators

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

Sponsor

The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

December 1, 2023

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

January 25, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AA-PRP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Menstrual Irregularity

Clinical Trials on Platelet Rich Plasma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe