An interventional study of Platelet Rich Plasma and Placebo in Cesarean Section Complications, Uterine Bleeding and Pelvic Pain, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in Israel. Open to female participants aged 18 Years to 52 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Prevention
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.
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 30-20 cc 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 to prevent platelet activation prior to its use. The preparation process requires centrifugation to separate the red blood cells (RBC) and to concentrate the 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 double blinded study. Study population will include all women planned to undergo elective cesarean delivery at term with singleton pregnancy. Women meeting inclusion criteria will be offered to participate in the study. After signing informed consent, block randomization will be completed, including: A- administration of PRP following uterine incision repair, B - administration of placebo (0.9% normal saline) 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 at six weeks, 3 months and 6 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
90 studies on the registry are indexed under Uterine Hemorrhage; 13 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 62 interventional studies indexed under Uterine Hemorrhage.
Browse Uterine Hemorrhage studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PRP preparation will be injected to the myometrium around the uterine incision after closure of the first layer.
Other: Platelet Rich Plasma
0.9% of Normal Saline will be injected to the myometrium around the uterine incision after closure of the first layer.
Other: Placebo
Injection of 5cc of PRP preparation at the myometrium around the uterine incision after it has been sutured.
Injection of 5cc of 0.9% Normal Saline at the myometrium around the uterine incision after it has been sutured.
Depth of the uterine scar (mm)
Depth of the uterine scar evaluated by transvaginal ultrasound
Time frame: At 6 weeks, 3 months, and 6 months after the cesarean delivery
Residual myometrial thickness/Adjacent myometrial thickness
Ratio between adjacent and residual myometrial thickness
Time frame: At 6 weeks, 3 months, and 6 months after the cesarean delivery
Niche length
Niche length (mm)
Time frame: At 6 weeks, 3 months, and 6 months after the cesarean delivery
Niche width
Niche width evaluated by transvaginal ultrasound
Time frame: At 6 weeks, 3 months, and 6 months after the cesarean delivery
Plan to share: Undecided
Started Jul 2025 (actual). Primary completion is estimated for Jul 2028, 35 months after the start.
Of 17 interventional studies with no phase under Uterine Hemorrhage, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's planned 35 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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