NCT04519840

Brief Summary

Purpose: The purpose of the proposed study is to examine the ability of diastasis recti abdominis to predict outcomes of Sacroiliac joint dysfunction and pelvic floor dysfunction.

  • Sample: The study will use a purposive sampling to select 120 subjects, ages 18-45, in the postpartum period between 12 weeks and 48 weeks. All subjects should have resided in the UAE minimum of 6 months prior to taking part in the study. Data analysis:
  • The age range of the subjects as well as the mean age with standard deviation will be determined.
  • Data will be analyzed using Multivariate Linear Regression Analysis for the primary research question.
  • For the Ssecondary research questions will include difference in DRA will be analyzed byas below:
  • SIJ Dysfunction (logistic regression-Odds ratio)
  • PFDI (Low, Moderate, High) (ANOVA/Kruskal Wallace Wallis Test)
  • Pelvic Fascia excursion (Low, Moderate, High). (ANOVA/Kruskal Wallace Wallis Test)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

August 17, 2020

Last Update Submit

August 17, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • presence of Diastasis Recti Abdominus

    Primary outcome

    48 weeks

Secondary Outcomes (2)

  • sacroiliac joint somatic dysfunction

    48 weeks

  • Pelvic floor disorder

    48 weeks

Interventions

nillOTHER

nill

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details12-48 weeks postpartum between ages of 18-45 years
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

• The study will use a purposive sampling of 120 subjects, ages 18-45, in the postpartum period between 12 weeks and 48 weeks. All subjects will live in the United Arab Emirates minimum of 6 months prior to taking part in the study.

You may qualify if:

  • Eligible participant should be 12-48 weeks postpartum between ages of 18-45 years
  • Maximum two Cesarean section delivery with no vaginal deliveries.

You may not qualify if:

  • ● Participant will be excluded (identified with the assistance of a health screening questionnaire):
  • History of traumatic injury to the lumbar-pelvic region, hip or lower extremities
  • Morbid Obesity: Participants with more than 35 kg/m2 body mass index will be excluded.
  • History of systemic disease affecting the musculoskeletal, neuromuscular and cardiopulmonary systems
  • Cardiovascular disease affecting lung function.
  • History of traumatic injury to the lumbar-pelvic region, hip or lower extremities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dubai Hospital

Dubai, 00971, United Arab Emirates

Location

Related Publications (20)

  • Sperstad JB, Tennfjord MK, Hilde G, Ellstrom-Engh M, Bo K. Diastasis recti abdominis during pregnancy and 12 months after childbirth: prevalence, risk factors and report of lumbopelvic pain. Br J Sports Med. 2016 Sep;50(17):1092-6. doi: 10.1136/bjsports-2016-096065. Epub 2016 Jun 20.

    PMID: 27324871BACKGROUND
  • Ostgaard HC, Roos-Hansson E, Zetherstrom G. Regression of back and posterior pelvic pain after pregnancy. Spine (Phila Pa 1976). 1996 Dec 1;21(23):2777-80. doi: 10.1097/00007632-199612010-00013.

    PMID: 8979325BACKGROUND
  • Lee D, Hodges PW. Behavior of the Linea Alba During a Curl-up Task in Diastasis Rectus Abdominis: An Observational Study. J Orthop Sports Phys Ther. 2016 Jul;46(7):580-9. doi: 10.2519/jospt.2016.6536.

    PMID: 27363572BACKGROUND
  • Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008 Jun;17(6):794-819. doi: 10.1007/s00586-008-0602-4. Epub 2008 Feb 8.

    PMID: 18259783BACKGROUND
  • Broadhurst NA, Bond MJ. Pain provocation tests for the assessment of sacroiliac joint dysfunction. J Spinal Disord. 1998 Aug;11(4):341-5.

    PMID: 9726305BACKGROUND
  • Laslett M, Aprill CN, McDonald B, Young SB. Diagnosis of sacroiliac joint pain: validity of individual provocation tests and composites of tests. Man Ther. 2005 Aug;10(3):207-18. doi: 10.1016/j.math.2005.01.003.

    PMID: 16038856BACKGROUND
  • Vleeming A, de Vries HJ, Mens JM, van Wingerden JP. Possible role of the long dorsal sacroiliac ligament in women with peripartum pelvic pain. Acta Obstet Gynecol Scand. 2002 May;81(5):430-6. doi: 10.1034/j.1600-0412.2002.810510.x.

    PMID: 12027817BACKGROUND
  • Freburger JK, Riddle DL. Using published evidence to guide the examination of the sacroiliac joint region. Phys Ther. 2001 May;81(5):1135-43. No abstract available.

    PMID: 11319939BACKGROUND
  • O'Sullivan PB, Beales DJ, Beetham JA, Cripps J, Graf F, Lin IB, Tucker B, Avery A. Altered motor control strategies in subjects with sacroiliac joint pain during the active straight-leg-raise test. Spine (Phila Pa 1976). 2002 Jan 1;27(1):E1-8. doi: 10.1097/00007632-200201010-00015.

    PMID: 11805650BACKGROUND
  • Bruno PA, Millar DP, Goertzen DA. Inter-rater agreement, sensitivity, and specificity of the prone hip extension test and active straight leg raise test. Chiropr Man Therap. 2014 Jun 16;22:23. doi: 10.1186/2045-709X-22-23. eCollection 2014.

    PMID: 24982755BACKGROUND
  • Mota P, Pascoal AG, Sancho F, Bo K. Test-retest and intrarater reliability of 2-dimensional ultrasound measurements of distance between rectus abdominis in women. J Orthop Sports Phys Ther. 2012 Nov;42(11):940-6. doi: 10.2519/jospt.2012.4115. Epub 2012 Jul 18.

    PMID: 22810966BACKGROUND
  • Chiarello CM, McAuley JA. Concurrent validity of calipers and ultrasound imaging to measure interrecti distance. J Orthop Sports Phys Ther. 2013;43(7):495-503. doi: 10.2519/jospt.2013.4449. Epub 2013 Apr 30.

    PMID: 23633625BACKGROUND
  • Butowicz CM, Ebaugh DD, Noehren B, Silfies SP. VALIDATION OF TWO CLINICAL MEASURES OF CORE STABILITY. Int J Sports Phys Ther. 2016 Feb;11(1):15-23.

    PMID: 26900496BACKGROUND
  • Barton A, Serrao C, Thompson J, Briffa K. Transabdominal ultrasound to assess pelvic floor muscle performance during abdominal curl in exercising women. Int Urogynecol J. 2015 Dec;26(12):1789-95. doi: 10.1007/s00192-015-2791-9. Epub 2015 Jul 28.

    PMID: 26215905BACKGROUND
  • Fonseca H, Silva AM, Matos MG, Esteves I, Costa P, Guerra A, Gomes-Pedro J. Validity of BMI based on self-reported weight and height in adolescents. Acta Paediatr. 2010 Jan;99(1):83-8. doi: 10.1111/j.1651-2227.2009.01518.x.

    PMID: 19878130BACKGROUND
  • Al-Shehri AH, Taha AZ, Bahnassy AA, Salah M. Health-related quality of life in type 2 diabetic patients. Ann Saudi Med. 2008 Sep-Oct;28(5):352-60. doi: 10.5144/0256-4947.2008.352.

    PMID: 18779640BACKGROUND
  • Mota P, Pascoal AG, Carita AI, Bo K. Normal width of the inter-recti distance in pregnant and postpartum primiparous women. Musculoskelet Sci Pract. 2018 Jun;35:34-37. doi: 10.1016/j.msksp.2018.02.004. Epub 2018 Feb 20.

  • Bo K, Hilde G, Tennfjord MK, Sperstad JB, Engh ME. Pelvic floor muscle function, pelvic floor dysfunction and diastasis recti abdominis: Prospective cohort study. Neurourol Urodyn. 2017 Mar;36(3):716-721. doi: 10.1002/nau.23005. Epub 2016 Mar 31.

  • Gillard S, Ryan CG, Stokes M, Warner M, Dixon J. Effects of posture and anatomical location on inter-recti distance measured using ultrasound imaging in parous women. Musculoskelet Sci Pract. 2018 Apr;34:1-7. doi: 10.1016/j.msksp.2017.11.010. Epub 2017 Nov 22.

  • Mota P., Pascoal A.G., Vaz C., João F., Veloso A., Bø K. (2018) Diastasis Recti During Pregnancy and Postpartum. In: Brandão S., Da Roza T., Ramos I., Mascarenhas T. (eds) Women's Health and Biomechanics. Lecture Notes in Computational Vision and Biomechanics, vol 29. Springer, Cham. https://doi.org/10.1007/978-3-319-71574-2_10

    RESULT

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Study Officials

  • Meeyoung Kim, PhD

    University of Sharjah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

August 17, 2020

First Posted

August 20, 2020

Study Start

December 15, 2020

Primary Completion

March 1, 2021

Study Completion

August 1, 2021

Last Updated

August 18, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

f prediction association is evident between diastasis recti abdominis and sacroiliac joint dysfuction medical record number and measurement scores will be used for further analysis for providing an experimental study. In which intervention will be applied for diastasis recti abdominis and observing the effect of that at sacroiliac joint dysfunction.

Shared Documents
ICF
Time Frame
one year
Access Criteria
only investigators

Locations