NCT03780530Unknown3 期
Comparison of Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 207
- 主要终点
- Short -term postpartum pain
研究概览
简要总结
this study aims to assess the efficacy and the safety of various cosmetic techniques (subcuticular, surgical glue, adhesive tapes) for perineal skin closure during mediolateral episiotomy repair
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged above 18 yrs.
- •Primiparous.
- •Undergoing spontaneous vaginal delivery of a single full-term fetus.
- •Vertex presentation.
- •Having mediolateral episiotomy.
排除标准
- •Body mass index ≥ 35 kg/m2
- •Complicated delivery by any tears other than episiotomy or postpartum hemorrhage.
- •Any risk factor causing increased stretch of the perineum; Operative vaginal delivery, fetal macrosomia.
- •The use of epidural anesthesia.
- •Previous perineal surgeries, local infection or lesions.
- •Any medical condition that can cause excessive bleeding or impair wound healing; (cardiovascular disease, diabetes, anemia, coagulopathy, collagen disease or Immunosuppression).
- •Contraindication or Hypersensitivity to any of materials used in the study.
研究组 & 干预措施
subcuticular suturing
Active Comparator
干预措施: subcuticular suturing (Procedure)
surgical glue
Active Comparator
干预措施: Surgical glue (Procedure)
adhesive steri-strip tape
Active Comparator
干预措施: adhesive steri-strip tape (Procedure)
结局指标
主要结局
Short -term postpartum pain
时间窗: 10 days postnatal
Post-operative perineal pain will be evaluated at 10 days after the procedure using visual analogue scale patient to choose a number from 0 to 10 that best describes their current pain. 0 would mean "no pain" and 10 would mean "worst possible pain
次要结局
未报告次要终点
研究者
Radwa Rasheedy Ali
Principal Investigator
Ain Shams University
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