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

Pelvic Floor Disorders Clinical Trial

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

Clinical Trial 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)

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04519840
Study type Observational [Patient Registry]
Source Dubai Health Authority
Contact
Status Completed
Phase
Start date December 15, 2020
Completion date August 1, 2021
View Details
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