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Platelet Rich Plasma for Uterine Scar (AA-PRP)

Primary Purpose

Cesarean Section Complications, Uterine Bleeding, Pelvic Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Platelet Rich Plasma
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Section Complications focused on measuring uterine scar defect, cesarean delivery, pelvic pain, spotting, niche, cesarean section complication, uterine scar, Platelet Rich Plasma (PRP)

Eligibility Criteria

18 Years - 52 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    PRP Treatment

    Control

    Arm Description

    PRP preparation will be applied on uterine incision after its closure.

    Normal Cesarean delivery stages.

    Outcomes

    Primary Outcome Measures

    Residual myometrial thickness
    Residual myometrial thickness at the uterine scar (mm)

    Secondary Outcome Measures

    Residual myometrial thickness/Adjacent myometrial thickness
    Ratio between adjacent and residual myometrial thickness
    Niche depth
    Niche depth (mm)
    Niche length
    Niche length (mm)

    Full Information

    First Posted
    January 25, 2022
    Last Updated
    May 18, 2023
    Sponsor
    The University of Texas Health Science Center, Houston
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05224726
    Brief Title
    Platelet Rich Plasma for Uterine Scar
    Acronym
    AA-PRP
    Official Title
    Platelet Rich Plasma for the Treatment of Uterine Scar
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    July 2025 (Anticipated)
    Study Completion Date
    July 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Texas Health Science Center, Houston

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cesarean Section Complications, Uterine Bleeding, Pelvic Pain, Menstrual Irregularity
    Keywords
    uterine scar defect, cesarean delivery, pelvic pain, spotting, niche, cesarean section complication, uterine scar, Platelet Rich Plasma (PRP)

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized control study
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PRP Treatment
    Arm Type
    Experimental
    Arm Description
    PRP preparation will be applied on uterine incision after its closure.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Normal Cesarean delivery stages.
    Intervention Type
    Other
    Intervention Name(s)
    Platelet Rich Plasma
    Intervention Description
    Applying 5cc of PRP preparation on uterine incision after it has been sutured.
    Primary Outcome Measure Information:
    Title
    Residual myometrial thickness
    Description
    Residual myometrial thickness at the uterine scar (mm)
    Time Frame
    6 months after cesarean delivery
    Secondary Outcome Measure Information:
    Title
    Residual myometrial thickness/Adjacent myometrial thickness
    Description
    Ratio between adjacent and residual myometrial thickness
    Time Frame
    6 months after cesarean delivery
    Title
    Niche depth
    Description
    Niche depth (mm)
    Time Frame
    6 months after cesarean delivery
    Title
    Niche length
    Description
    Niche length (mm)
    Time Frame
    6 months after cesarean delivery

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    52 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aya Mohr-Sasson, M.D
    Phone
    3462704682
    Email
    aya.mohrsasson@uth.tmc.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    25722595
    Citation
    Dhurat R, Sukesh M. Principles and Methods of Preparation of Platelet-Rich Plasma: A Review and Author's Perspective. J Cutan Aesthet Surg. 2014 Oct-Dec;7(4):189-97. doi: 10.4103/0974-2077.150734.
    Results Reference
    result
    PubMed Identifier
    12418561
    Citation
    Schilephake H. Bone growth factors in maxillofacial skeletal reconstruction. Int J Oral Maxillofac Surg. 2002 Oct;31(5):469-84. doi: 10.1054/ijom.2002.0244.
    Results Reference
    result
    PubMed Identifier
    12608674
    Citation
    Sanchez AR, Sheridan PJ, Kupp LI. Is platelet-rich plasma the perfect enhancement factor? A current review. Int J Oral Maxillofac Implants. 2003 Jan-Feb;18(1):93-103.
    Results Reference
    result
    PubMed Identifier
    33723748
    Citation
    Sharara FI, Lelea LL, Rahman S, Klebanoff JS, Moawad GN. A narrative review of platelet-rich plasma (PRP) in reproductive medicine. J Assist Reprod Genet. 2021 May;38(5):1003-1012. doi: 10.1007/s10815-021-02146-9. Epub 2021 Mar 15.
    Results Reference
    result
    PubMed Identifier
    33299482
    Citation
    Goncalves NJN, Frantz N, de Oliveira RM. Platelet-rich plasma (PRP) therapy: An approach in reproductive medicine based on successful animal models. Anim Reprod. 2020 May 22;16(1):93-98. doi: 10.21451/1984-3143-AR2018-093.
    Results Reference
    result
    PubMed Identifier
    34733236
    Citation
    Lin Y, Qi J, Sun Y. Platelet-Rich Plasma as a Potential New Strategy in the Endometrium Treatment in Assisted Reproductive Technology. Front Endocrinol (Lausanne). 2021 Oct 18;12:707584. doi: 10.3389/fendo.2021.707584. eCollection 2021.
    Results Reference
    result
    PubMed Identifier
    34415119
    Citation
    Ferrari AR, Cortrezzi S, Borges E Junior, Braga D, Souza MDCB, Antunes RA. Evaluation of the Effects of Platelet-Rich Plasma on Follicular and Endometrial Growth: A Literature Review. JBRA Assist Reprod. 2021 Oct 4;25(4):601-607. doi: 10.5935/1518-0557.20210036.
    Results Reference
    result
    PubMed Identifier
    32700285
    Citation
    Petryk N, Petryk M. Ovarian Rejuvenation Through Platelet-Rich Autologous Plasma (PRP)-a Chance to Have a Baby Without Donor Eggs, Improving the Life Quality of Women Suffering from Early Menopause Without Synthetic Hormonal Treatment. Reprod Sci. 2020 Nov;27(11):1975-1982. doi: 10.1007/s43032-020-00266-8. Epub 2020 Jul 22.
    Results Reference
    result
    PubMed Identifier
    19565535
    Citation
    Wang CB, Chiu WW, Lee CY, Sun YL, Lin YH, Tseng CJ. Cesarean scar defect: correlation between Cesarean section number, defect size, clinical symptoms and uterine position. Ultrasound Obstet Gynecol. 2009 Jul;34(1):85-9. doi: 10.1002/uog.6405.
    Results Reference
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    PubMed Identifier
    27393285
    Citation
    Tulandi T, Cohen A. Emerging Manifestations of Cesarean Scar Defect in Reproductive-aged Women. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):893-902. doi: 10.1016/j.jmig.2016.06.020. Epub 2016 Jul 5.
    Results Reference
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    PubMed Identifier
    2437359
    Citation
    Semenova LS, Evlashko IuP, Sorkina NS. [Concentration of lead and several components of porphyrin metabolism in the blood and urine of persons with no industrial contact with lead]. Lab Delo. 1987;(2):11-4. No abstract available. Russian.
    Results Reference
    result

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    Platelet Rich Plasma for Uterine Scar

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