Perineal Consequences of Twin Pregnancies According to Mode of Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,039
- 试验地点
- 2
- 主要终点
- Presence/absence of urinary incontinence
研究概览
简要总结
This is an ancillary study to the "JUMODA" (National Prospective and Comparative Study on the Mode of Delivery of Twins) study: please see NCT01987063.
The main objective of this study is to investigate the role of the mode of delivery (vaginal versus cesarean) as a risk factor for the occurrence of urinary incontinence at 3 months post-delivery in primiparous women delivering twins after 34 weeks of pregnancy.
详细描述
The secondary objectives of this study are to compare the following elements between primiparous mothers giving birth to twins vaginally versus by caesarean section after 34 weeks of pregnancy (comparisons will be made at 3 months ant at 12 months post-partum):
A. Diagnosis, type and severity of urinary incontinence via the ICIQ-UI questionnaire
B. Urinary, anorectal and perineal symptoms via the PFDI-20 questionnaire
C. Quality of life related to urinary, anorectal and pelvic floor symptoms via the PFIQ-7 questionnaire
D. Sexuality via the PISQ-12 questionnaire
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
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 12 months of follow-up following delivery
- •The patient was included in the JUMODA study
- •Primiparous
- •Birth of 2 live children after 34 weeks of pregnancy
排除标准
- •Adult patient under guardianship
- •Patient under judicial protection
- •It proves impossible to correctly inform the patient
- •Birth occurring before 34 weeks of pregnancy
- •Birth not resulting in 2 living children
结局指标
主要结局
Presence/absence of urinary incontinence
时间窗: 3 months post-partum
Defined by a response of 1 to 5 on the first question of the ICIQ-UI questionnaire.
次要结局
- The PFDI-20 questionnaire(12 months post-partum)
- The PISQ-12 questionnaire(12 months post-partum)
- The PFIQ-7 questionnaire(12 months post-partum)
- The SF-12 questionnaire(12 months post-partum)
- The ICIQ-UI questionnaire(12 months post-partum)