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

NCT ID: NCT04519840

Last Updated: 2021-08-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2021-08-01

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)

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.

Conditions

Diastasis Recti; Sacroiliac Joint Somatic Dysfunction; Pelvic Floor Disorders

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

nill

nill

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dubai Health Authority

OTHER_GOV

Sponsor Role: lead

Responsible Party

Enas Mohammad Taher Abu Saleh

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meeyoung Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sharjah

Locations

Dubai Hospital

Dubai, , United Arab Emirates

Countries

United Arab Emirates

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Other Identifiers

DubaiHA

Identifier Type: -

Identifier Source: org_study_id