Impact of Pelvic Floor Musculature on Peripartum Outcomes: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Serial changes in pelvic floor anatomy and function
研究概览
简要总结
The purpose of this study is to understand the effect of the pregnancy on the muscles in the pelvis. The purpose of this study is to evaluate the pelvic muscle changes related to pregnancy; to assess if the ability to squeeze and relax these muscles has any effect on delivery mode and if there are any injuries to the pelvic muscles.
详细描述
Healthy women who are pregnant with their first child will be included in the study. Information about their general health will be gathered. These women will be screened for pelvic disorders at the start and end of study. Three-dimensional ultrasound will be performed three times: 12-24 weeks, 34-39 weeks and 4-6 weeks after delivery. Fetal measurements will be included in the third trimester ultrasound for prediction of estimated birth weight. The relationship of the predicted fetal weight and the likelihood of having a successful vaginal delivery will be studied. Images will be analyzed for pelvic muscles function and injuries. Information regarding the length of labor, types of delivery and vaginal tears will be gathered. The information obtained will be analyzed to look for the strength of correlation of variables to the outcomes.
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
- 是
入选标准
- •Primiparous or should not have given birth to a fetus older than 12 weeks.
- •Singleton pregnancy.
- •Age more than or equal to 18 years.
- •Basal mass index between 18 - 40 kg/m
- •Must plan to deliver at Strong Memorial Hospital at the University of Rochester Medical Center.
排除标准
- •Basal mass index more than 40 kg/m
- •Presence of current or prior history of cervical incompetence.
- •Presence of diabetes mellitus (type I or type II).
- •Presence of connective-tissue disorders such as Systemic lupus erythematosus, Rheumatoid Arthritis, or Sjogren's disease.
- •Presence of neuromuscular disorders such as myasthenia gravis and neuropathies.
结局指标
主要结局
Serial changes in pelvic floor anatomy and function
时间窗: 12-24 weeks, 34-39 weeks gestation, and 4-6 weeks postpartum
To evaluate the serial changes in pelvic floor anatomy and function during the second, third trimester of pregnancy and in the postpartum period.
次要结局
未报告次要终点
研究者
Tulin Ozcan MD
Associate Professor
University of Rochester