Pelvic Floor Muscle Assessment at 3-and 4-dimensional Transperineal Ultrasound and Its Relation to Pregnancy and Labor
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Change in Levator Hiatus Area at Rest Measured Via 3-dimensional transperineal Ultrasound at Gestational Week 24 and 37
研究概览
简要总结
Injuries to the pelvic floor muscles and fascias during delivery and childbirth may lead to urinary incontinence (25-45 %), faecal incontinence (11-45%), pelvic organ prolapse (7-23%), sexual dysfunction (15-33 %) and chronic pain syndromes (4-15%). Pelvic floor muscle injuries are not easy to diagnose as they are not visible when looking at surface anatomy during a standard gynaecological examination. The investigators are therefore in urgent need of better tools to diagnose these injuries. Having a reliable and easily accessible tool enables studies of the consequences of such pelvic floor muscle injuries. It also makes it possible for us to explore the effect of interventions such as pelvic floor muscle training and surgery in patients with and without pelvic floor muscle injuries. The investigators have previously presented data to support the reliability and the validity of the three and four dimensional (3 and 4D) ultrasound technique used to define pelvic floor muscle anatomy in healthy volunteers and have now a tool to study women before and after delivery.
详细描述
At the Department of Obstetrics and Gynaecology, Cairo University Hospital there are approximately 29000 deliveries annually and 10000 women are giving birth for the first time.
Challenges: The invitation to participate in the study will be given to all women expecting their first child fulfilling inclusion criteria. The biggest challenges in the project will be logistical. To be able to inform, recruit and follow women having their first child is a challenge in itself.
Applications: If it is possible to identify a risk group for pelvic floor injuries before delivery, it might be ethical to recommend a prophylactic cesarean section to avoid disabling incontinence and prolapse later in life.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women giving birth to their first child at Cairo University Hospital, Egypt and University Hospital Würzburg, Germany.
排除标准
- •Previous pregnancy of more than 16 weeks.
- •preterm delivery less than 32 weeks gestation.
结局指标
主要结局
Change in Levator Hiatus Area at Rest Measured Via 3-dimensional transperineal Ultrasound at Gestational Week 24 and 37
时间窗: 24 weeks and 37 weeks of gestation
3-dimensional ultrasound was used to capture the axial plane of the pelvic floor in order to measure LH area. Levator hiatus area was measured at gestational week 24 and 37, at rest, during contraction and during Valsalva maneuver - giving 6 measurements all together. The change in LH area was computed between the two different timepoints giving 3 outcomes
次要结局
- Change in Levator Hiatus Area at Contraction Measured Via 3D transperineal Ultrasound at Gestational Week 24 and 37(24 weeks and 37 weeks of gestation)
- Change in Levator Hiatus Area During Valsalva Maneuver Measured Via 3D transperineal Ultrasound(gestational week 24 and 37)
研究者
Ahmed Samy aly ashour
Assistant professor of obstetrics and gynecology
Cairo University