The Pelvic Floor Future Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- The long-term impact of a new vaginal delivery on anal sphincter function in women with previous obstetric anal sphincter injury.
研究概览
简要总结
The goal of this observational study is to learn more about the effect a pregnancy and delivery has on the function of the anal musculature.We will compare women who had a new delivery after suffering a severe tear in the anal musculature in their first pregnancy, with women who had two or more vaginal deliveries, but did not suffer such an injury.
The main questions we want to answer is:
- can the burden of a new pregnancy and delivery weaken the function of the repaired musculature in a way that might cause symptoms of anal incontinence later in life?
- can a tear in the anal musculature increase the risk of developing urinary incontinence and long term sexual dysfunction?
- should we recommend these women to have a caesarian section instead of a new vaginal delivery?
Participants will be asked to complete an electronic questionnaire with information regarding their pregnancies, deliveries and potential symptoms from anal incontinence, urinary incontinence and sexual dysfunction.
Researchers will compare these two groups to find out if a new vaginal delivery has a negative effect on the function of the anal musculature.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Sphincter group: Previous obstetric anal sphincter injury during vaginal childbirth in 2002-2018 and having a subsequent vaginal delivery without such injury
- •control group: Two or more vaginal deliveries without obstetric anal sphincter injury
排除标准
- •under 18 years
- •consent incompetency
- •Obstetric anal sphincter injury in subsequent pregnancies
- •caesarian section in subsequent pregnancy
结局指标
主要结局
The long-term impact of a new vaginal delivery on anal sphincter function in women with previous obstetric anal sphincter injury.
时间窗: 5- 20 years
Number of participants with previous OASI who had a new vaginal delivery will be compared to participants with similar parity, without previous OASI. Differences in anal incontinence symptom score and quality of life will be measured by study questionnaires (St. Marks score, PFDI-20 and PFIQ-7).
次要结局
- Prevalence of urinary incontinence among women with previous OASI compared to women with similar parity without obstetric anal sphincter injury(5-20 years)
- The risk of long- term dyspareunia and sexual dysfunction after previous obstetric anal sphincter injury compared to women with similar parity without obstetric anal sphincter injury.(5-20 years)
研究者
Sissel Oversand
Principal investigator
Oslo University Hospital