The Role of Platelet Rich Plasma in Supporting the Recovery of Post-partum Levator Ani Muscle Trauma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Changes of Levator Hiatal Area During Valsava
研究概览
简要总结
Levator trauma (ballooning) often occurs after vaginal delivery. Platelet rich plasma injection after delivery showed reduced hiatal area and maintain levator muscle strength.
详细描述
This study aims to see if PRP has a beneficial effect on the repair of pelvic floor muscle damage in primipara. Therefore, this single-blinded randomized clinical trial compares the pelvic floor muscle repair in primipara following labor between the interventional group who received intramuscular PRP injection in levator ani muscle and the control group, as assessed by ultrasonography, perineometry. The ultrasonography outcome measures include lower hiatal area during Valsalva. The assessments are performed at multiple time points, which are before labor, 24-48 hours post-labor, 40 days post-labor, and 3 months post-labor.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •primigravida, in third trimester pregnancy
- •plan to do vaginal birth
- •have a clear address and telephone number that can be contacted
- •consent to participate in this study
排除标准
- •history of pelvic floor disorder before pregnancy
- •history of pelvic surgery
- •avulsion of levator ani muscle (seen in USG)
- •unstable hemodynamic
- •trombocytopenia (< 150,000)
- •anemia (Hb< 10)
- •infection on perineum
- •corticosteroid intake within last 2 weeks
- •hematopoetic or bone cancer
- •delivery by c-section
- •no perineoraphy after birth
研究组 & 干预措施
Intervention Group
Platelet rich plasma injected intramuscularly in pelvic floor muscle immediately following labor and before perineoraphy, simultaneously with the injection of local anesthesia
干预措施: Platelet Rich Plasma (Biological)
Control Group
No intervention given, patient will only get local anesthesia injection before perineoraphy
结局指标
主要结局
Changes of Levator Hiatal Area During Valsava
时间窗: Baseline (third trimester), 40 days post-partum, 3 months post-partum
Changes in lower hiatal area during valsalva in various measurements (compared to baseline value), measured using translabial 3D ultrasound. With the translabial technique at an angle of 70 degrees or more, the entire levator hiatus and surrounding muscles (pubococcygeus and puborectalis) can be visualized. It is hoped that ultrasound is more reproducible because axial measurements are easier with minimal dimensional images, at rest, valsalva, or contraction.
Changes in Pelvic Floor Muscle Contraction
时间窗: Baseline (third trimester), 40 days post partum, and 3 months post partum
Changes in pelvic floor muscle contraction in various measurements (compared to baseline), measured using perineometer
次要结局
未报告次要终点
研究者
Fernandi Moegni
M.D., Obstetric and gynaecologist, Urogynaecologist
Dr Cipto Mangunkusumo General Hospital