the Key Laboratory of Female Pelvic Floor Disorders Diseases, Beijing, China
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Incidence of pelvic floor muscle strength abnormality at different postpartum time
研究概览
简要总结
The main purpose of this study was to observe the pelvic floor muscle strength abnormalities of cesarean section and vaginal delivery at different time points within six months after delivery without any intervention. It was a prospective observational study, and the main study population was healthy postpartum women. Regular follow-up was conducted at 6 weeks, 9 weeks, 3 months, 4 months, 5 months and 6 months postpartum. The follow-ups included gynecological examination, pelvic floor electrophysiological indexes (category I and II muscle fiber strength and fatigue), questionnaire (ICI- Q-SF, OABSS, UDI-6), and pelvic floor ultrasound. The incidence of pelvic floor muscle strength abnormality at different postpartum time points was statistically analyzed, the high-risk factors of postpartum pelvic floor function abnormality caused by pregnancy and delivery were analyzed, and the general rules of the natural development of pelvic floor function were observed.
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
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 20 ~35 years old; 2) first parturients registered in the obstetrics department of our hospital; 3) no medical complications before pregnancy, no UI and POP (according to the standard of POP-Q stage); 4) no obstetric complications; 5) the patients agreed to conduct the study and signed the informed consent.
排除标准
- •patients with uncontrolled epilepsy, central nervous system diseases or mental disorders, whose clinical severity shall be determined by the researcher to affect clinical research compliance; 2) follow up the patients with difficulty.
结局指标
主要结局
Incidence of pelvic floor muscle strength abnormality at different postpartum time
时间窗: 6 month
次要结局
未报告次要终点