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临床试验/NCT04660708
NCT04660708进行中(未招募)不适用

Effect of Manual Pelvic Floor Physical Therapy During Pregnancy on Perineal Trauma and Pain in the Post Partum Period

University of Wisconsin, Milwaukee2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2020年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
105
试验地点
2
主要终点
Amount of perineal tearing

研究概览

简要总结

The purpose of this study is to explore the impact of pelvic floor physical therapy during pregnancy on delivery and the impact on the woman's body and function. Currently there have not been any studies to our knowledge that have examined this relationship and the outcomes for the pregnant patient. The current research that is available is on pelvic floor training and perineal massage during pregnancy with positive outcomes. The questions we are looking to answer include:

  1. Does pelvic floor physical therapy during pregnancy decrease the severity of perineal trauma during delivery?
  2. Does pelvic floor physical therapy during pregnancy decrease the length of the second stage of labor (pushing)?
  3. Does pelvic floor physical therapy during pregnancy decrease the occurrence of emergency C-section?

详细描述

The purpose of this study is to explore the impact of pelvic floor manual physical therapy techniques during pregnancy on delivery and the impact on the woman's body and function. Currently there have not been any studies to our knowledge that have examined this relationship and the outcomes for the pregnant patient. The current research that is available is on pelvic floor training and perineal massage during pregnancy with positive outcomes. Perineal massage is a stretching technique utilized to relax the tissue of the perineum (the area between the vaginal opening and anus), and is considered routine physical therapy standard of care for pregnant women. Myofascial release of the pelvic floor is a specific manual therapy technique to relax the muscles of the pelvic floor which can include the superficial perineal area. Pelvic myofascial release is a technique used for both pregnant women, and women with chronic pelvic pain. In fact, each component of assessment and treatment are routine and standard PT practices (evaluation, manual therapy, exercise, education), however this specific manual therapy treatment protocol has not been studied during pregnancy to assess the benefits on delivery/recovery. The questions we are looking to answer include:

  1. Does pelvic floor PT (physical therapy) during pregnancy decrease the severity of perineal trauma during delivery?
  2. Does pelvic floor PT during pregnancy decrease the length of the second stage of labor (pushing)?
  3. Does pelvic floor PT during pregnancy decrease the occurrence of emergency C-section?
  4. Does pelvic floor PT during pregnancy decrease the likelihood and/or severity of postpartum pelvic pain and pelvic dysfunction? By obtaining these findings, it will allow for program design and treatment recommendations within the pregnancy period to minimize delivery trauma and risk for the mother.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • Pregnant women (any pregnancy, first or subsequent) planning for a vaginal delivery
  • 28-34 weeks gestation at the start of treatment

排除标准

  • Planned c-section
  • < 18 years old
  • >34 weeks gestation
  • Women on pelvic rest

结局指标

主要结局

Amount of perineal tearing

时间窗: 7 weeks

measured in cm

Quality of Life and Symptoms Distress Inventory

时间窗: 7 weeks

standardized survey to assess level of urinary leakage post partum (0-45 with the higher score indicating greater impairment

Pregnancy Mobility Index

时间窗: 7 weeks

standardized survey to determine functional mobility post partum (0 - 72 with a higher score indicating greater impairment)

Length of labor

时间窗: 7 weeks

length of labor measured in hours

Delivery type

时间窗: 7 weeks

natural or cesarean section (categorical data)

次要结局

未报告次要终点

研究者

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

Wendy Huddleston

Associate Professor

University of Wisconsin, Milwaukee

研究点 (2)

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