Efficiency of Autologous Amniotic Fluid Injection in the Healing of Cesarean Section Scar in High-Risk Population
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Quality of wound healing
研究概览
简要总结
The goal of this randomized controlled trial is to investigate the effect of injection of autologous amniotic fluid in the healing of the scar of cesarean section among high-risk population. Investigator's aim is to know : quality of wound healing, rate of infection and time needed for complete healing. Participants will be divided into two groups. All participants will undergo cesarean section. We will inject autologous amniotic fluid in the edges of the wound during skin closure in half of the participants. Wound healing will be assessed at 1st, 2nd and 6th week postoperatively.
详细描述
After surgery, participants will be observed along 6 weeks (at 1, 2 and 6 weeks intervals) and scars will be assessed regarding color, thickness, pliability and presence of exudate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 30 years old.
- •Anemic patients
- •Maternal chronic disease e.g., Diabetes and Hypertension
- •BMI of > 25 Kg/m
- •Underwent previous CS.
排除标准
- •Rupture of membrane.
- •No previous section.
- •Anhydraminos.
- •Congenital malformation of the fetus.
结局指标
主要结局
Quality of wound healing
时间窗: 1,2,6 weeks postoperative
Scars will be assessed objectively regarding Color, Thickness, Pliability, Exudate in participants and controls
次要结局
未报告次要终点
研究者
Hend Mahmoud Abdelghany
Lecturer of Obstetrics and Gynecology, Cairo University
Kasr El Aini Hospital