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

August 17, 2021 updated by: Enas Mohammad Taher Abu Saleh, Dubai Health Authority

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence of Diastasis Recti Abdominus
Time Frame: 48 weeks
Primary outcome
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sacroiliac joint somatic dysfunction
Time Frame: 48 weeks
Secondary outcome
48 weeks
Pelvic floor disorder
Time Frame: 48 weeks
secondary outcome
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dubai Health Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2020

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

August 17, 2020

First Submitted That Met QC Criteria

August 17, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DubaiHA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

one year

IPD Sharing Access Criteria

only investigators

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pelvic Floor Disorders

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe