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Diastasis Recti Abdominis Association With Sacroiliac Joint and Pelvic Floor Dysfunction in Postpartum C-section Women

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04519840
Recruitment Status : Completed
First Posted : August 20, 2020
Last Update Posted : August 18, 2021
Sponsor:
Information provided by (Responsible Party):
Enas Mohammad Taher Abu Saleh, Dubai Health Authority

Study Description
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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)

Condition or disease Intervention/treatment
Diastasis Recti Sacroiliac Joint Somatic Dysfunction Pelvic Floor Disorders Other: nill

Detailed Description:

The data recorded for each subject will include: medical record number (MRN), type of delivery, measurement values and presence or absence of DRA as well as general health information collected in the health screening questionnaire. All identifiers will be kept separately , and password protected only accessed by Primary Investigator. Unless required by law or in the event of medical emergency, MRN of any subject will not be disclosed to anyone by the investigator. Under no circumstances will the personal identity of any subject be revealed in any form of a publication or presentation.

With the exception of the subject's medical record number as well as signed forms (consent and health questionnaire), all recorded study data will be identified using only a unique number for each subject. A paper master list will be kept that matches each medical record number to their identification number and kept in a separate locked and secured cabinet from the rest of the data. Other than that, the signed forms, all other data will be recorded initially on a paper sheet then transferred to an electronic spreadsheet. When not under direct supervision of the investigator, all paper records will be kept secure in locked filing cabinets, accessible only to the investigator. All data stored electronically will be maintained and backed up in an encrypted format with the password known only to the investigator. Subjects will be provided with a photocopy of the signed consent form.

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 32 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: A Cross Sectional Study to Determine the Association Between Diastasis Recti Abdominis and Sacroiliac Joint and Pelvic Floor Dysfunction Outcomes Among Postpartum Women Who Underwent C-section in UAE
Actual Study Start Date : December 15, 2020
Actual Primary Completion Date : March 1, 2021
Actual Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: nill
    nill

Outcome Measures
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Primary Outcome Measures :
  1. presence of Diastasis Recti Abdominus [ Time Frame: 48 weeks ]
    Primary outcome


Secondary Outcome Measures :
  1. sacroiliac joint somatic dysfunction [ Time Frame: 48 weeks ]
    Secondary outcome

  2. Pelvic floor disorder [ Time Frame: 48 weeks ]
    secondary outcome


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   12-48 weeks postpartum between ages of 18-45 years
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • ● 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.
Contacts and Locations
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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): NCT04519840


Locations
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United Arab Emirates
Dubai Hospital
Dubai, United Arab Emirates, 00971
Sponsors and Collaborators
Dubai Health Authority
Investigators
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Principal Investigator: Meeyoung Kim, PhD University of Sharjah
More Information
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Publications of Results:
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

Other Publications:

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Responsible Party: Enas Mohammad Taher Abu Saleh, Physiotherapist, Dubai Health Authority
ClinicalTrials.gov Identifier: NCT04519840    
Other Study ID Numbers: DubaiHA
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Informed Consent Form (ICF)
Time Frame: one year
Access Criteria: only investigators

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diastasis, Muscle
Pelvic Floor Disorders
Pregnancy Complications
Joint Dislocations
 Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries