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AfterBabyBodyStudy- Testing Manual Examination Methods and Exercise Effects on Muscular Recovery After Pregnancy

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03703804
Recruitment Status : Recruiting
First Posted : October 12, 2018
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Maria Larsson, Vastra Gotaland Region

Brief Summary:

Exercising postpartum is important for the health of mother and child. However, there are physical changes postpartum which can prevent women from exercising postpartum. About 30% of women postpartum have problems with stress urinary incontinence. Almost as many have a remaining separation of the two parts of the muscle rectus abdominis. Over the last decenium there has been an increased interest but also disparate information about these conditions. This has led to an increased uncertainty among women who wants to resume exercising postpartum. More and more women seek help of physiotherapists to verify an appropriate function in their muscles after pregnancy. However, reliable and valid examination methods are scarce and it is unclear how to interpret the examination results to give individualized exercise advice.

The aim of this study is to test the reliability of examination methods for the pelvic floor function and separation of the rectus abdominis and the criterion validity of these examination methods regarding exercising without leaking urine and lumbopelvic pain. Another aim is to identify if exercising postpartum has effects on the function of the muscles and (less) leaking of urine and lumbopelvic pain/disability.

Recruitment of 300 women approximately 8 weeks postpartum in the Region Västra Götaland. For testing interrater reliability on manual examination of the pelvic floor and the separation of the rectus abdominis by caliper two physiotherapists will examine the participants´ pelvic floor and abdominal muscles. The examinations will be tested for criterion validity using a questionnaire for pelvic floor function, lumbopelvic pain/disability and physical activity level. In an observational component of this study the questionnaire will also be used to evaluate the effects of exercising postpartum on the recovery of pelvic floor and abdominal muscles at 6, 9 and 12 months postpartum.

This study will provide knowledge about the reliability of examination methods for pelvic floor function and separation of the rectus abdominis, their correlation to urinary leakage and pain/disability (criterion validity) and the effects of exercising on muscle function postpartum.


Condition or disease
Postpartum Period Pelvic Floor Diastasis Recti Exercise

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The AfterBabyBodyStudy- Testing Manual Examination Methods and Exercise Effects on Muscular Recovery After Pregnancy
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 15, 2022
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Women postpartum
Women -over 18 years, ability to understand Swedish in spoken and written terms, gave birth to a child approximately 3 months ago via vaginal delivery or cesarean section will be included. Exclusion criteria will be chronic pain in the pelvis or back (defined as pain in pelvic or back in more than 3 months before pregnancy), major rupture of the pelvic floor at delivery e.g. sphincter rupture grade III/IV or other diseases or surgery that prevents examination of the pelvic floor or abdominal muscles.



Primary Outcome Measures :
  1. Pelvic floor function [ Time Frame: From baseline to 12 month follow upp ]
    Pelvic floor function will be rated on a modified oxford scale (0 = no contraction, 1 = flicker, 2 = weak, no lift, 3 = good contraction with lift, 4 = maximal contraction (with lift) and 5 = maximal contraction with lift over 5 seconds.

  2. Diastasis recti abdominis [ Time Frame: From baseline to 12 month follow upp ]
    measured in mm by a caliper

  3. Urinary incontinence [ Time Frame: From baseline to 12 month follow upp ]
    Urinary incontinence assessed by ICIQ-UI short form (rated from 0-21, + questions about functional leakage)

  4. Lumbopelvic pain/disability [ Time Frame: From baseline to 12 month follow upp ]
    assessed by oswestry disability index/Roland morris disability index (0-100% function)/pelvic girdle pain questionnaire (0-100% function)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women over 18 years old, gave birth via vaginal delivery or c-section
Criteria

Inclusion Criteria:

  • Women -over 18 years, ability to understand Swedish in spoken and written terms, gave birth to a child approximately 3 months ago via vaginal delivery or cesarean section will be included.

Exclusion Criteria:

  • chronic pain in the pelvis or back (defined as pain in pelvic or back in more than 3 months before pregnancy),
  • major rupture of the pelvic floor at delivery e.g. sphincter rupture grade III/IV
  • other diseases or surgery that prevents examination of the pelvic floor or abdominal muscles.

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): NCT03703804


Locations
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Sweden
Närhälsan Göteborg Recruiting
Göteborg, Västra Götalandregionen, Sweden
Contact: Maria Larsson, Associate Professor    +46767905400    Maria.eh.larsson@vgregion.se   
Contact: Sabine Vesting, PhD-student    +46768335925    sabine.vesting@vgregion.se   
Sponsors and Collaborators
Vastra Gotaland Region

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Responsible Party: Maria Larsson, Associate Professor, Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT03703804    
Other Study ID Numbers: VGFOUREG-832541
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No