Can Perineal Tears and Obstetric Anal Sphincter Injuries in Palestine be Prevented? A Study of Two Different Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51,041
- 试验地点
- 4
- 主要终点
- Incidence of obstetric perineal injuries
研究概览
简要总结
In this study the investigators want to assess complications associated to pregnancy and delivery, and interventions used during labor.
Pregnancy and delivery related complications are a major health problem globally. Events during labor such as excessive bleeding, uterine rupture, emergency cesarean delivery; other instrumental deliveries and anesthesia problems are situations that potentially may lead to severe outcomes for the mother and child.
Diabetes, anemia and hypertensive disorders may also complicate both the pregnancy and delivery.
Between 60-80% of women delivering their first baby need suturing due to perineal tears (tears located to the area between the vagina and anus). Superficial perineal tears rarely cause long-term problems, but often lead to pain and discomfort immediately after birth. Deeper or severe perineal tears, involving the anal sphincter, may influence the woman's quality of life. This is mainly due to long-lasting pain, discomfort and sexual dysfunction, and the fact that obstetric anal sphincter tear is the main cause of anal incontinence. Recent clinical intervention studies have shown that the incidence of severe obstetric perineal tears may be reduced by 50-70% by introducing a bimanual support technique of the perineum. In these studies all midwives and gynecologists were trained in the bimanual support technique. When it comes to training in new medical techniques in general, some studies have shown that use of animated instructions on mobile phones may be a good alternative to the more traditional "hands-on" or "bedside" teaching methods. In a global perspective, it is important to study the efficacy of mobile units for transferring of new knowledge, especially for use in resource constrained settings.
详细描述
The main aim is to study the incidence of major delivery complications and perineal injuries during vaginal delivery in Palestine. A manual support technique of perineum will be introduced.
- To assess the incidence of perineal tears, episiotomies, obstetric anal sphincter injuries and major obstetric complications in Palestine in a multicenter study involving three hospitals on the West Bank and three hospitals in Gaza.
- To assess the present treatment of obstetric anal sphincter tears in Palestine.
- To study whether intervention with bed-side training of the hands-on "the Norwegian-Finnish" support technique reduce the incidence of obstetric anal sphincter tears.
- To study whether training by animated instructions of the same hands-on support technique, using smart phones or tablet computers, reduce the incidence of obstetric anal sphincter injuries.
- To compare results between the two different training methods.
- To study midwives' and doctors' attitudes towards "hands-on" training compared to training by animated instructions. The main aim is to assess the incidence of perineal injuries during vaginal delivery in Palestine, and to introduce a manual support technique of perineum. Norwegian intervention studies have shown that the incidence of obstetric anal sphincter injuries (OASIS) can be reduced by 40-70% by improving hands-on delivering techniques. The reduction was achieved by educating all staff on the delivery unit, implementing a new hands-on delivering technique. Some previous research has shown that non-interactive training by animated instructions or videos in emergency obstetric care, might be equally effective as conventional interactive hands-on training. However, the effectiveness of training by animated instructions compared to conventional training programs remains to be assessed properly. By performing a multicentre intervention study, the investigators will explore the effect of interactive hands-on training on the incidence of perineal injuries. Likewise the investigators will study effect of non-interactive training by animated instructions. Three hospitals on the West Bank (WB) and three in Gaza have accepted to participate. The investigators will also assess whether attitudes towards training methods influence the results.
The steps of observation, training and interventions in this study:
- Intervention 1 (1 month):
Education in diagnosis and repair of perineal injuries and implementation of system to register data. 2. Observation 1 (6 months):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all midwives and physicians working on labor ward in the participating hospitals.
- •all women giving birth in the participating hospitals.
- •both genders are included in the staff, and among the newborns
排除标准
- •no exclusion criteria, the study aim is the education of the staff, and hospitals are compared as units.
结局指标
主要结局
Incidence of obstetric perineal injuries
时间窗: 24 months
All degrees of perineal injuries, including episiotomies, before and after intervention (education of the labour room staff)
次要结局
- Occurrence of major delivery complications(24 months)
- Occurrence of perineal injuries after education of the staff on diagnostics and repair(24 months)
研究者
Erik Fosse
Professor, Head of Department
Oslo University Hospital