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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05224726
Other study ID # AA-PRP
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2023
Est. completion date July 2025

Study information

Verified date May 2023
Source The University of Texas Health Science Center, Houston
Contact Aya Mohr-Sasson, M.D
Phone 3462704682
Email aya.mohrsasson@uth.tmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 52 Years
Eligibility 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 Design


Intervention

Other:
Platelet Rich Plasma
Applying 5cc of PRP preparation on uterine incision after it has been sutured.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

References & Publications (11)

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. — View 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: 10.5935/1518-0557.20 — View 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. — View 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. — View 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 No — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Residual myometrial thickness Residual myometrial thickness at the uterine scar (mm) 6 months after cesarean delivery
Secondary Residual myometrial thickness/Adjacent myometrial thickness Ratio between adjacent and residual myometrial thickness 6 months after cesarean delivery
Secondary Niche depth Niche depth (mm) 6 months after cesarean delivery
Secondary Niche length Niche length (mm) 6 months after cesarean delivery
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