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
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Proportion of participants who have perineal tears
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
- 否
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
结局指标
主要结局
Proportion of participants who have perineal tears
时间窗: At 15 minutes from delivery
Proportion of perineal tears will be assessed by an investigator who will attend the participant delivery
次要结局
- Proportion of participants who need episiotomy at time of delivery(At 15 minutes from delivery)
- Duration of the second stage of labour(At 15 minutes from delivery)
研究者
Eman Omran
Principal investigator
Cairo University