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临床试验/NCT02304016
NCT02304016Unknown不适用

Evaluation of the Effect of Pelvic Floor Physical Therapy on Patients With 3rd and 4th Degree Obstetrical Lacerations

Boston Urogynecology Associates4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
4
主要终点
Improvement in pelvic floor function (change in PFDI-20)

研究概览

简要总结

The purpose of this study is to determine if patients with third and fourth degree obstetric lacerations benefit from a short course of pelvic floor physical therapy in the immediate postpartum period.

详细描述

The proposed study is a prospective, randomized pilot trial. We aim to answer the question: do patients with third and fourth degree obstetric lacerations benefit from a short course pelvic floor physical therapy in the immediate postpartum period?

Forty patients experiencing third or fourth degree obstetric laceration at either BIDMC or Mount Auburn Hospital will be identified and randomized in a 1:1 ratio. Half of the patients will receive a 10-12 week course of pelvic floor physical therapy at Marathon PT to begin one to two weeks postpartum. Those assigned to the control will not receive pelvic floor physical therapy which is the current standard of care. They will also agree not to seek pelvic floor physical therapy during until at least 14 weeks postpartum without discussing with study investigators. At 14 weeks postpartum they will be offered pelvic floor physical therapy. At 1-2 weeks postpartum, 6-8 weeks postpartum, and 12-14 weeks postpartum, all study subjects will complete the Pelvic Floor Impact Questionnaire - 7 (PFIQ-7), the Pelvic Floor Distress Inventory - 20 (PFDI-20), the Female Sexual Function Index (FSFI), the Patient Global Impression of Severity (PGI-S) Scale and the Patient Global Impression of Improvement (PGI-I) Scale all of which are validated surveys. Surveys will be completed online via REDCap using computers at Marathon PT for treatment group subjects and at home or in a location of their choosing for control subjects. Control patients will be given the option of beginning pelvic floor PT after 14 weeks postpartum. Should they decide to pursue pelvic floor PT at that time, they will have the option to continue to fill out periodic surveys via REDCap, but will not be required to do so.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • Vaginal delivery at either BIDMC or Mt. Auburn Hospital complicated by either third or fourth degree perineal laceration
  • Age 18 or older

排除标准

  • History of previous vaginal delivery after 24 weeks gestation

研究组 & 干预措施

Pelvic floor physical therapy

Experimental

干预措施: Pelvic floor physical therapy (Behavioral)

Observatoin

No Intervention

结局指标

主要结局

Improvement in pelvic floor function (change in PFDI-20)

时间窗: 12-24 weeks

The primary outcome will be the change in PFDI-20 from baseline to the final assessment at approximately 12-24 weeks postpartum

次要结局

未报告次要终点

研究者

发起方
Boston Urogynecology Associates
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eman Elkadry, M.D.

Clinical Instructor

Boston Urogynecology Associates

研究点 (4)

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