Manual Fascial Manipulation in Pregnant Women

NCT03041246 | Completed

• 1 other identifier: 3722-16-SMC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Disorders

Keywords

pelvic floor

Outcome Measures

Primary Outcomes (2)

• Contraction strength

  Contraction strength assessed by Oxford grading scale

  Change of contraction strength is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )

• Contraction pressure

  Contraction pressure measured by using Peritron perineometer

  Change of contraction pressure is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )

Secondary Outcomes (3)

• Symptoms associated with pelvic dysfunction

  Change of pelvic dysfunction is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )

• FEV1

  Change of FEV1 is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )

• Voice Handicap Index - 10 among Hebrew speakers (VHI-10-HEB) questionaire

  Change of VHI-10-HEB is assessed - from baseline to 2 weeks after last treatment ( up to maximum of 1 month )

Study Arms (2)

Study group - Treatment with PFFM

EXPERIMENTAL

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

Control group -

NO INTERVENTION

Guidance towards exercise for strengthening of the pelvic floor with no other interventional treatment.

Interventions

Pelvic floor fascial mobilization PROCEDURE

The manual manipulation of the pelvic floor involves intra vaginal superficial as well as pelvic skin area pressure points.

Study group - Treatment with PFFM

Eligibility Criteria

• Age: 18 Years - 42 Years
• Gender Eligibility Details: Women that are pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 20-45 years old
• Gestational age 24-30 weeks gestation
• Singleton pregnancy
• Expected second-4ourth delivery

You may not qualify if:

• First delivery
• Gestational age at more than 30 weeks gestation at enrollment
• Premature contractions
• Cervical insufficiency
• Placenta previa
• Placenta accrete
• Multifetal pregnancy
• Maternal chronic illness including connective tissue disease, neurological illness

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

Related Publications (8)

• Batista EM, Conde DM, Do Amaral WN, Martinez EZ. Comparison of pelvic floor muscle strength between women undergoing vaginal delivery, cesarean section, and nulliparae using a perineometer and digital palpation. Gynecol Endocrinol. 2011 Nov;27(11):910-4. doi: 10.3109/09513590.2011.569603. Epub 2011 Apr 18.

  PMID: 21500994 BACKGROUND

• Hallock JL, Handa VL. The Epidemiology of Pelvic Floor Disorders and Childbirth: An Update. Obstet Gynecol Clin North Am. 2016 Mar;43(1):1-13. doi: 10.1016/j.ogc.2015.10.008.

  PMID: 26880504 BACKGROUND

• Navot S, Kalichman L. Hip and groin pain in a cyclist resolved after performing a pelvic floor fascial mobilization. J Bodyw Mov Ther. 2016 Jul;20(3):604-9. doi: 10.1016/j.jbmt.2016.04.005. Epub 2016 Apr 7.

  PMID: 27634085 BACKGROUND

• Okido MM, Valeri FL, Martins WP, Ferreira CH, Duarte G, Cavalli RC. Assessment of foetal wellbeing in pregnant women subjected to pelvic floor muscle training: a controlled randomised study. Int Urogynecol J. 2015 Oct;26(10):1475-81. doi: 10.1007/s00192-015-2719-4. Epub 2015 Aug 21.

  PMID: 26294205 BACKGROUND

• Petricelli CD, Resende AP, Elito Junior J, Araujo Junior E, Alexandre SM, Zanetti MR, Nakamura MU. Distensibility and strength of the pelvic floor muscles of women in the third trimester of pregnancy. Biomed Res Int. 2014;2014:437867. doi: 10.1155/2014/437867. Epub 2014 Apr 28.

  PMID: 24877094 BACKGROUND

• Talasz H, Kofler M, Kalchschmid E, Pretterklieber M, Lechleitner M. Breathing with the pelvic floor? Correlation of pelvic floor muscle function and expiratory flows in healthy young nulliparous women. Int Urogynecol J. 2010 Apr;21(4):475-81. doi: 10.1007/s00192-009-1060-1. Epub 2009 Dec 8.

  PMID: 19997721 BACKGROUND

• van Veelen GA, Schweitzer KJ, van der Vaart CH. Ultrasound imaging of the pelvic floor: changes in anatomy during and after first pregnancy. Ultrasound Obstet Gynecol. 2014 Oct;44(4):476-80. doi: 10.1002/uog.13301.

  PMID: 24436146 BACKGROUND

• Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.

  PMID: 32378735 DERIVED

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: February 2, 2017
• Study Start: July 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)