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Manual Fascial Manipulation in Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041246
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Aya Mohr-Sasson, Sheba Medical Center

Brief Summary:
Pregnancy and vaginal delivery are considered as the main risk factors for damage to the pelvic floor. There are various ways to measure the strength of the pelvic floor and to evaluate functional problems. Manual mobilization of the pelvic floor is a well-known treatment modality, however, ample knowledge exists on the efficacy of physiotherapy and exercise for improvement of pelvic floor function and strength. The aim of this study is to analyze the influence of pelvic floor fascial mobilization (PFFM) technique on the function and strength of the pelvic floor muscles as well as parameters presumed to be influenced by the strength of the pelvic floor in pregnant women.

Condition or disease Intervention/treatment Phase
Pelvic Floor Disorders Procedure: Pelvic floor fascial mobilization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: On enrollment, dividing the healthy ( n=40) from the pathological function of the pelvic floor ( n=40). From the second group, randomizing the groups to study group: recieving pelvic floor fascial mobilization (PFFM) treatment (n=20)compared to control group (n=20).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Influence of Manual Fascial Manipulation on the Function of the Pelvic Floor in Pregnant Women
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : June 1, 2020
Actual Study Completion Date : June 1, 2020

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Arm Intervention/treatment
Experimental: Study group - Treatment with PFFM
Manual treatment for the pelvic floor will be provided in two sessions two weeks apart as long as guidance towards exercise for strengthening of the pelvic floor
Procedure: Pelvic floor fascial mobilization
The manual manipulation of the pelvic floor involves intra vaginal superficial as well as pelvic skin area pressure points.

No Intervention: Control group -
Guidance towards exercise for strengthening of the pelvic floor with no other interventional treatment.



Primary Outcome Measures :
  1. Contraction strength [ Time Frame: Change of contraction strength is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month ) ]
    Contraction strength assessed by Oxford grading scale

  2. Contraction pressure [ Time Frame: Change of contraction pressure is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month ) ]
    Contraction pressure measured by using Peritron perineometer


Secondary Outcome Measures :
  1. Symptoms associated with pelvic dysfunction [ Time Frame: Change of pelvic dysfunction is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month ) ]
    Assessment of symptoms associated with pelvic dysfunction: urinary incontinence, fecal incontinence, frequency and urgency (by the use of pelvic floor disability index 20 - a questionaire including 20 questions on pelvic floor function)

  2. FEV1 [ Time Frame: Change of FEV1 is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month ) ]
    Forced expiratory volume 1

  3. Voice Handicap Index - 10 among Hebrew speakers (VHI-10-HEB) questionaire [ Time Frame: Change of VHI-10-HEB is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month ) ]
    Evaluation of the validity of the voice handicap index that includes ten questions concerning voice usage among hebrew speakers



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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women that are pregnant
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Age 20-45 years old
  2. Gestational age 24-30 weeks gestation
  3. Singleton pregnancy
  4. Expected second-4ourth delivery

Exclusion criteria

  1. First delivery
  2. Gestational age at more than 30 weeks gestation at enrollment
  3. Premature contractions
  4. Cervical insufficiency
  5. Placenta previa
  6. Placenta accrete
  7. Multifetal pregnancy
  8. Maternal chronic illness including connective tissue disease, neurological illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041246


Locations
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Israel
Sheba Medical Center
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Aya Mohr-Sasson, Principal Investigator, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03041246    
Other Study ID Numbers: 3722-16-SMC
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Aya Mohr-Sasson, Sheba Medical Center:
pelvic floor
Additional relevant MeSH terms:
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Pelvic Floor Disorders
Pregnancy Complications