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CompletedNCT03041246Updated Jun 9, 2020

Manual Fascial Manipulation in Pregnant Women

An interventional study of Pelvic floor fascial mobilization in Pelvic Floor Disorders, sponsored by Sheba Medical Center. Completed at 1 site in Israel. Open to female participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-09.

Sponsored by Sheba Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 42 Years
Sex
Female
01

Study 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.

Read the detailed description

Pregnancy and vaginal delivery are considered as the main risk factors for damage to the pelvic floor at various degrees, starting at mild stress incontinence and up to fool fecal incontinence as well as pelvic pains or urination difficulties.

There are various ways to measure the strength of the pelvic floor and to evaluate functional problems. Measured the strength of the pelvic floor muscles by physical examination according to Oxford Grading Scale (scale of 0-5) as well as by using Perineometer device, were equally efficient and well correlated. Other modalities such as the use of surface electro myography (EMG), that presents the level of the muscle electrical activity and expiration volumes and the strength of the pelvic floor muscles were also positively correlated to the strength of the pelvic floor. Recent studies presented dysfunction of pelvic floor during pregnancy as well as in the postpartum period by the use of pelvic floor disability index 20 (PFDI20) questionnaire validated in Hebrew.

Ample knowledge exists on the efficacy of physiotherapy and exercise for improvement of pelvic floor function and strength, however, prolonged and continuous exercise is needed to achieve good results as well as compliance and perseverance. The long-term effect is unwieldly.

Manual mobilization of the pelvic floor is a well-known treatment modality. However the literature regarding the effect of this technique is sparse. A recent series of case reports presented immediate and major improvement of pelvic floor dysfunction after manual mobilization. The peripartum period is critical for the function of the pelvic floor however the yield of manual therapy on function and strength of the pelvic floor was not evaluated in pregnant women. We hypothesize that manual therapy can improve the strength and the function of the pelvic floor within a short time span and this can be objectively measured by common and well used parameters The aim of this study is to analyze the influence of pelvic floor fascial mobilization (PFFM) 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

Materials and methods

The study will involve number of phases:

Phase one: Screening and enrollment of patients Women followed at the high risk pregnancy clinic at the Sheba medical center, who carry singleton pregnancy at the ages of 20-45 years old and about to have their 2nd to 4th delivery (primiparous and multiparous women) will be examined for the following parameters: demographic and medical data, focused interview for symptoms of pelvic floor dysfunction including urination and fecal function as well as pelvic floor pain, manual assessment according the Oxford grading scale will be performed, and the strength of the pelvic floor measured by the use of Perineometer (Peritron 'AV' Combined Anal \& Vaginal Perineometer NEW MODEL). Other parameters that will be measured include: mobilization of the pelvic-femoral joint, Forced expiratory volume 1 (FEV1) (a connection was shown between FEV1, intraabdominal pressure and the strength of the pelvic floor, assessment of vocal quality ( analyzed by communication clinician, repeat assessment will be performed after two weeks and after 4 weeks, estimated assessment time - 20 Min) 80 women are expected to be enrolled.

Phase Two Women who will fulfill one or more of the following parameters will be enrolled to the second phase of the study . (n=40)

  1. Oxford grading scale ≤3/5
  2. Pelvic floor strength assessed by perineometer≤ 30 cm/h20
  3. Clinical symptoms of urine, flatus or fecal incontinence
  4. Pelvic floor, hip joint or pelvic joints pain

Randomization will be performed to one of two groups:

Group A-Control group (n=20) Group B-Study group (n=20) Guidance towards exercise for strengthening of the pelvic floor will be provided for both groups. Study group will be treated manually for the pelvic floor in two sessions two weeks apart. The manual manipulation of the pelvic floor will involve intra vaginal superficial as well as pelvic skin area pressure points. The manipulation will not involve the cervix uterus or rectum. Each session will lasts one hour

Both groups will be assessed by ultrasound for blood flow in the middle cerebral artery, umbilical artery and uterine artery as part of the parameters that may show benefit to the fetus due to pelvic floor mobilization.

Reassessment of all the women and repeat treatment for the study group will be performed after two and four weeks from the primary assessment.

The study will be performed at a high risk pregnancy clinic at the Sheba medical center. Women will be enrolled voluntarily with no financial benefit.

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Conditions studied

  • Pelvic Floor Disorders

Keywords

  • pelvic floor
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In context

Pelvic Floor Disorders

197 studies on the registry are indexed under Pelvic Floor Disorders; 45 are open to participants now.

This study's enrollment of 80 is above the median of 64 across 136 interventional studies indexed under Pelvic Floor Disorders.

Browse Pelvic Floor Disorders studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • 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

  • No intervention
    Control group -

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

Interventions

  • ProcedurePelvic floor fascial mobilization

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

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What researchers measure

Primary outcomes

  1. Contraction strength

    Contraction strength assessed by Oxford grading scale

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

  2. Contraction pressure

    Contraction pressure measured by using Peritron perineometer

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

Secondary outcomes

  1. Symptoms associated with pelvic dysfunction

    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)

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

  2. FEV1

    Forced expiratory volume 1

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

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

    Evaluation of the validity of the voice handicap index that includes ten questions concerning voice usage among hebrew speakers

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

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Study locations

1 site
  • Sheba Medical Center
    Ramat Gan, Israel
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References and documents

Publications

  • 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. PubMed 21500994 ↗
  • 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. PubMed 26880504 ↗
  • 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. PubMed 27634085 ↗
  • 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. PubMed 26294205 ↗
  • 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. PubMed 24877094 ↗
  • 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. PubMed 19997721 ↗
  • 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. PubMed 24436146 ↗
  • 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. PubMed 32378735 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03041246
Lead sponsor
Sheba Medical Center
Responsible party
Dr. Aya Mohr-Sasson (Principal Investigator, Sheba Medical Center) — Principal investigator
First posted
Feb 2, 2017
Start date
Jul 1, 2018
Primary completion
Jun 1, 2020
Completion
Jun 1, 2020
Last update
Jun 9, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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