跳至主要内容
临床试验/NCT05224726
NCT05224726招募中不适用

Platelet Rich Plasma for the Treatment of Uterine Scar

The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Depth of the uterine scar (mm)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 52 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

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

排除标准

  • •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)

研究组 & 干预措施

PRP Treatment

Experimental

PRP preparation will be injected to the myometrium around the uterine incision after closure of the first layer.

干预措施: Platelet Rich Plasma (Other)

Placebo

Placebo Comparator

0.9% of Normal Saline will be injected to the myometrium around the uterine incision after closure of the first layer.

干预措施: Placebo (Other)

结局指标

主要结局

Depth of the uterine scar (mm)

时间窗: At 6 weeks, 3 months, and 6 months after the cesarean delivery

Depth of the uterine scar evaluated by transvaginal ultrasound

次要结局

  • Residual myometrial thickness/Adjacent myometrial thickness(At 6 weeks, 3 months, and 6 months after the cesarean delivery)
  • Niche length(At 6 weeks, 3 months, and 6 months after the cesarean delivery)
  • Niche width(At 6 weeks, 3 months, and 6 months after the cesarean delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aya Mohr Sasson

Principle investigator

The University of Texas Health Science Center, Houston

研究点 (1)

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