The Occurrence of Single Nucleotide Polymorphism Among Women Who Experienced Obstetric Anal Sphincter Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- difference in the frequency of of Single-nucleotide polymorphisms
研究概览
简要总结
Single-nucleotide polymorphisms (SNP's) in connective tissue components are associated with increased risk of pelvic organ prolapse (POP). The investigators expect to find a difference in SNP's frequency between women who had Obstetric anal sphincter injuries (OASIS) and in the healthy population. The fact that pelvic organ prolapse (POP) and OASIS occurs in the same anatomic region and the well-known association between few SNP's and the risk for POP, suggests for a common pathophysiology.
详细描述
The perineum consists of skin, muscles and connective tissue. A connective tissue disorder related to POP has been reported in biochemical and molecular studies. OASIS are considered a severe complication of vaginal delivery that may lead to a great deal of morbidity. Familial history is known as a risk factor for OASIS. Currently, there is no established genetic link between connective tissue components and OASIS. Therefore, the investigators assume that studying the genetic predisposition factors of women who experience OASIS, might generate a stronger tool to predict severe occurrence of vaginal laceration. It may also help to consult women before vaginal delivery about the risk of OASIS.
The aim of this study is to find an association between genetic variation and increased risk for OASIS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with severe external anal sphincter injury during first vaginal delivery
- •Healthy women undergoing vaginal delivery without any clinically apparent perineal laceration
排除标准
- •Women with known metabolic or connective-tissue disorder (e.g., Ehlers-Danlos syndrome).
- •Women with known neurologic disorder
- •Women undergoing episiotomy cut or assisted delivery (e.g., vacuum or forceps delivery)
研究组 & 干预措施
women with external anal sphincter injury
The study cohort will be composed of women undergoing vaginal delivery and diagnosed with external anal sphincter injury after a vaginal delivery.
干预措施: screening for single nucleotide polymorphism (Genetic)
women with external anal sphincter injury
The study cohort will be composed of women undergoing vaginal delivery and diagnosed with external anal sphincter injury after a vaginal delivery.
干预措施: whole exome sequencing (Genetic)
women without external anal sphincter injury
The control group will be women who had a vaginal delivery without any clinically apparent perineal laceration
干预措施: screening for single nucleotide polymorphism (Genetic)
结局指标
主要结局
difference in the frequency of of Single-nucleotide polymorphisms
时间窗: through study completion, an average of 2 years
difference in the relative frequency of Single-nucleotide polymorphisms between women with external anal sphincter injury that occurs during vaginal delivery and those without it.
次要结局
- genetic mutation(through study completion, an average of 2 years)
研究者
Eyal Rom, MD
Principal Investigator
HaEmek Medical Center, Israel