Do Women With Vaginal Birth After Caesarean Section Have an Increased Risk of Levator Avulsion?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 469
- 试验地点
- 2
- 主要终点
- Levator ani avulsion
研究概览
简要总结
There is no data regarding the risk of levator ani avulsion in women after a vaginal birth after caesarean although a possible increased risk has been suggested. The aim of the study is to describe the incidence of levator ani avulsion and compare it to primiparous women. In addition, health related quality of life will be evaluated and compared
详细描述
Levator ani muscle avulsion is a frequent postpartum trauma imposing a considerable risk of pelvic organ prolapse on women in later life. Furthermore, the trauma reduces the effectiveness of pelvic reconstructive surgery and has a detrimental effect of the sexuality of the affected women. The trauma occurs most frequently in the first vaginal delivery with an incidence of 10-30%. However, the risk of levator avulsion in women after vaginal birth after caesarean section (VBAC) is unknown although possible increased risk has been suggested.
The aim of the study is to assess the prevalence of levator ani avulsion among women who delivered vaginally after a caesarean section and make a comparison with a primiparous cohort. The secondary aim is to evaluate and compare the health related quality of life regarding pelvic floor disorders and sexuality.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •one term vaginal delivery in obstetric history
- •agreement with the enrollment
排除标准
- •Women with a history of repeat VBAC or a vaginal delivery prior to the index caesarean section
- •women with preterm labor
- •epidural analgesia
- •multiple pregnancy
- •dead or malformed fetus
结局指标
主要结局
Levator ani avulsion
时间窗: at least 6 months after the delivery
Presence of levator ani avulsion diagnosed by offline tomographic ultrasound imaging of an ultrasound volume of the pelvic floor
Genital hiatus ballooning
时间窗: at least 6 months after the delivery
Area of the urogenital hiatus over 25cm2 during maximal Valsalva
次要结局
- Pelvic floor dysfunction(at time of the ultrasound examination)
- Anal incontinence(at time of the ultrasound examination)
- Sexuality(at time of the ultrasound examination)
研究者
Zdenek Rusavy
Principal Investigator
Charles University, Czech Republic