Cesarean Section Complications Clinical Trial
— AA-PRPOfficial title:
Platelet Rich Plasma for the Treatment of Uterine Scar
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
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 all — Click here to view all references
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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