跳至主要内容
临床试验/NCT02512016
NCT02512016已完成不适用

Bridging Physical and Cultural Determinants of Postpartum Pelvic Floor Support and Symptoms Following Vaginal Delivery

University of Utah2 个研究点 分布在 1 个国家目标入组 1,079 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,079
试验地点
2
主要终点
Pelvic Floor Support

研究概览

简要总结

The Motherhood and Pelvic health study (MAP), Bridging physical and cultural determinants of postpartum pelvic floor support and symptoms following vaginal delivery, uses mixed methods research to study the influences of intra-abdominal pressure, physical activity and strength on pelvic floor support and symptoms and the cultural context in which women experience those changes.

详细描述

Vaginal delivery affects pelvic muscles, nerves and connective tissue. Despite the similarities between vaginal delivery and other non-pelvic soft tissue injuries, research to date has not focused on factors related to recovery from childbirth, but instead has been directed at intrapartum interventions. A woman's pelvic floor derives its ability to withstand loads from physical activities due to her inherent genetic make-up that sets the foundation for her muscle, connective tissue, bone and other structures, her history of injury, and her ability to recover from injuries. Over the past decade, investigators have gained important information about some of the ways in which vaginal delivery affects the structure and function of the pelvic floor.

However, investigators know very little about how pelvic floor function recovers after vaginal delivery. This study will look at whether the non-pregnant milieu, including physical and cultural factors, mediate the effects of vaginal childbirth. Study investigators propose that pelvic floor support and symptoms 1 year after the first vaginal delivery are affected by biologically plausible factors that may impact muscle, nerve and connective tissue healing during the postpartum recovery period (first 8 weeks postpartum) and pelvic floor function during the postpartum strengthening period (remainder of the first postpartum year): in particular, timing and dose of moderate/vigorous physical activity and inactivity, and timing of and exposure to a range of intra-abdominal pressures. Our investigators further propose that perception of pelvic floor support and symptoms 1 year after vaginal delivery are influenced by cultural attributes and beliefs. Finding relationships between physical activity, muscular strength, intra-abdominal pressure and pelvic floor support /symptoms will provide realistic targets for disease prevention and pelvic floor health management.

Hispanics are the fastest-growing ethnic group in the United States. Although the risks for pelvic floor disorders differ among ethnic and racial groups, few studies have examined these differences. There is a critical need for research among Hispanic women. In this Program, our investigators will study personal and cultural aspects of Mexican-American and Euro-American primiparas' experiences of the earliest changes that happen after childbirth and make them understandable to women and clinicians, creating an opportunity for dialogue across lay and medical discourses.

The aims of each project are summarized below.

PROJECT 1 Intra-abdominal pressure and postpartum pelvic floor support and symptoms

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 years and older
  • Estimated gestational age 28 weeks to 36 6/7 weeks
  • Nulliparous
  • Single gestation

排除标准

  • Obstructive pulmonary disease
  • Collagen disorder such as Marfan's or Ehlers-Danlos
  • Muscular dystrophy
  • Prior surgical procedure for urinary incontinence or pelvic organ prolapse
  • Required ambulatory aid before pregnancy
  • No access to telephone or computer during course of study

结局指标

主要结局

Pelvic Floor Support

时间窗: 1 Year postpartum

Assessed using the Pelvic Organ Prolapse Quantification examination, categorized into maximum vaginal descent at or below the hymen (\>/= 0 cm) versus above the hymen (\< 0 cm)

Pelvic Floor symptoms

时间窗: 1 Year postpartum

Assessed using the Epidemiology of Prolapse and Incontinence Questionnaire, dichotomized as the presence of symptoms accompanied by at least minimal bother (\>0 on the visual analogue scale) in at least 2 (vs 0 or 1) of the 6 domains

次要结局

  • Symptoms of Stress Urinary Incontinence(1 Year)
  • Overactive Bladder Symptoms(1 Year)
  • Constipation Symptoms(1 Year)
  • Urinary Incontinence Severity(1 Year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ingrid Nygaard

M.D.

University of Utah

研究点 (2)

Loading locations...

相似试验