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

NCT03703804 | Unknown

• 1 other identifier: VGFOUREG-832541
• Study Type: observational
• Target: 504
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Period; Pelvic Floor; Diastasis Recti; Exercise

Outcome Measures

Primary Outcomes (4)

• Pelvic floor function

  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.

  From baseline to 12 month follow upp

• Diastasis recti abdominis

  measured in mm by a caliper

  From baseline to 12 month follow upp

• Urinary incontinence

  Urinary incontinence assessed by ICIQ-UI short form (rated from 0-21, + questions about functional leakage)

  From baseline to 12 month follow upp

• Lumbopelvic pain/disability

  assessed by oswestry disability index/Roland morris disability index (0-100% function)/pelvic girdle pain questionnaire (0-100% function)

  From baseline to 12 month follow upp

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women over 18 years old, gave birth via vaginal delivery or c-section

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Närhälsan Göteborg

Gothenburg, Västra Götalandregionen, Sweden

Location

Related Publications (2)

• Vesting S, Gutke A, Fagevik Olsen M, Praetorius Bjork M, Rembeck G, Larsson MEH. Can Clinical Postpartum Muscle Assessment Help Predict the Severity of Postpartum Pelvic Girdle Pain? A Prospective Cohort Study. Phys Ther. 2022 Dec 30;103(1):pzac152. doi: 10.1093/ptj/pzac152.

  PMID: 36326139 DERIVED

• Vesting S, Olsen MF, Gutke A, Rembeck G, Larsson MEH. Clinical assessment of pelvic floor and abdominal muscles 3 months post partum: an inter-rater reliability study. BMJ Open. 2021 Sep 2;11(9):e049082. doi: 10.1136/bmjopen-2021-049082.

  PMID: 34475166 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 12, 2018
• Study Start: September 1, 2018
• Primary Completion: February 28, 2021
• Study Completion: December 31, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

SE (1)