the Efficacy of Intramuscular Autologous Platelet-rich Plasma Injection on Uterine Wound Healing After Primary Cesarean Section
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Presence of cesarean scar defect(niche)
研究概览
简要总结
The aim of this study is to evaluate the efficacy of intramuscular autologus platelet rich plasma on uterine wound healing after primary cesarean section
详细描述
110 pregnant female undergoing primary prelabor CS will be randomized to two groups group A)autologus PRP will be prepared from participant venous blood collected from the participants' arm into a syringe primed with ACD-A. then it will be injected into uterus after closing uterine incision . Injection sites will be selected near the incision at evenly 20 different sites
group B)normal saline 0.9 will be injected into uterus after closing uterine incision . Injection sites will be selected near the incision at evenly 20 different sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Term pregnancy (gestational age between 37-41 weeks).
- •Women undergoing cesarean section for the first time.
- •Normal vaginal ultrasound examination and exclusion of any pelvic abnormality.
- •Uncomplicated cesarean section.
- •Lower uterine segment cesarean sections while the women not in labor
排除标准
- •Women with complications during or after cesarean section as intrapartum or postpartum hemorrhage, puerperal sepsis, septic wound
- •Women with medical diseases that can affect the healing as diabetes mellitus, anemia, chronic renal disease or hepatic disease or coagulopathy or receiving medications affect wound healing as corticosteroids or anticoagulant.
- •Women who will use intrauterine device as a contraceptive method Women with uterine abnormality as cervical stenosis or fibroid uterus multiple gestation, placenta abruption, placenta previa, antepartum hemorrhage prolonged ROM, chorioamnionitis,meconium stained liquor
研究组 & 干预措施
PRP
55 participant unergoing prelabor primary CS will receive intramyometrial injection of PRP after closure of uterine incision
干预措施: autologus platelet rich plasma (Drug)
placebo
55 participant unergoing prelabor primary CS will receive intramyometrial injection of normal saline after closure of uterine incision
干预措施: placebo (Drug)
结局指标
主要结局
Presence of cesarean scar defect(niche)
时间窗: 12 weeks after CS
any defect in the anterior myometrium related to scar site
次要结局
未报告次要终点
研究者
Radwa Rasheedy Ali
lecturer
Ain Shams University