Digital Perineal Massage and Pelvic Floor Muscle Exercise as an Antenatal Program for Prevention of Perineal Trauma in Elderly Women, a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- perineal tears Proportion of perineal tears will be assessed by an investigator who will attend the participant delivery
研究概览
简要总结
Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. They will be also educated to do pelvic floor muscle exercises and will receive the usual education program for strengthening the pelvic floor. The second group will receive the usual education program for strengthening the pelvic floor. Occurrence of perineal laceration will be reported at time of delivery.
详细描述
Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. They will be also educated to do pelvic floor muscle exercises and will receive the usual educational pelvic floor dysfunction prevention program for strengthening the pelvic floor. The second group will receive the usual education program for strengthening the pelvic floor. Occurrence of perineal laceration will be reported at time of delivery.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women ≥ 35 years old
- •Primigravida or multi gravida
排除标准
- •History of chronic constipation
- •History of chronic cough
- •Current or past urinary or anal incontinence
- •History of genital prolapse before pregnancy
- •History of neuromuscular disorders or connective tissue disorders
- •History of medical disorders
- •History of preterm or precipitate labour
- •History of premature preterm rupture of membranes.
- •Genital infections
研究组 & 干预措施
three program
200 patients are subjected to educational Pelvic floor dysfunction prevention program with perineal massage and Pelvic floor muscle exercise.
干预措施: 3 program (Other)
one program
200 patients are subjected to educational Pelvic floor dysfunction prevention program
干预措施: one program (Other)
结局指标
主要结局
perineal tears Proportion of perineal tears will be assessed by an investigator who will attend the participant delivery
时间窗: At 15 minutes from delivery
Proportion of participants who have perineal tears
次要结局
- episiotomy need Proportion of participants who need episiotomy at time of delivery will be assessed by an investigator(At 15 minutes from delivery)
- Duration of the second stage of labour(2 hours)
研究者
Amira S Dieb
Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
Kasr El Aini Hospital