Prevalence of Diastasis m. Rectus Abdominis in Postpartum Women

July 4, 2022 updated by: Rastislav Dudič, MD, PhD., Pavol Jozef Safarik University

Prevalence of Diastasis m. Rectus Abdominis and Pelvic Floor Muscle Dysfunction in Postpartum Women

This study will evaluate the prevalence of diastasis m. rectus abdominis after delivery.

Relationship of Diastasis Recti Abdominis with urine leakage, pelvic floor muscle function and morphometry in postpartum women.

Study Overview

Status

Completed

Detailed Description

Evaluation of the width of the linea alba within the evaluation of diastasis of the rectus abdominis by 2D USG relation to pelvic floor muscle function (strength and endurance of pelvic floor muscles) and pelvic floor muscle morphometry by 3D/4D USG .

Study Type

Observational

Enrollment (Actual)

150

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

      • Košice, Slovakia, 04011
        • PJ Šafárik University

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women from six weeks to up to 6 months after birth, age over 18 years old.

Description

Inclusion Criteria:

  • Women from six weeks to up to 6 months after birth, age over 18 years old.

Exclusion Criteria:

  • Psychiatric illness, postpartum depression, non-cooperation. Neurological diseases conditions after a stroke, a history of brain injury, significant visual and hearing damage, confirmed by neurological examination. Serious internal, orthopedic and oncological diseases. Disagreement with inclusion in the study.

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
Prevalence of Diastasis Recti Abdominis in Postpartum Women.
Time Frame: Six weeks to up to 6 months after birth
IRD distance measured by a linear probe 2D usg, 4.5 cm above the navel, 4.5 cm below the navel. At rest, and when raising the lower limbs.
Six weeks to up to 6 months after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship of Diastasis Recti Abdominis with urine leakage, pelvic floor muscle function and morphometry in postpartum women.
Time Frame: Six weeks to up to 6 months after birth.
Occurrence of stress urinary incontinence using the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF).
Six weeks to up to 6 months after birth.
Relationship between Diastasis Recti Abdominis and back pain in postpartum women.
Time Frame: Six weeks to up to 6 months after birth.
Occurrence of low back pain using the Oswestry Disability Index (ODI).
Six weeks to up to 6 months after birth.

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Rastislav Dudič, PhD, Department of Gynecology and Obstetrics, Medical Faculty, PJ Safarik University, Kosice, Slovakia
  • Study Director: Magdalena Hagovska, Prof,PhD, KFBLR, Medical Faculty, PJ Safarik University, Kosice, Slovakia
  • Study Director: Jan Svihra, Prof,MD,PhD., Department of Urology, Institution, Comenius University Bratislava, Slovakia

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)

April 8, 2021

Primary Completion (Actual)

April 28, 2022

Study Completion (Actual)

May 23, 2022

Study Registration Dates

First Submitted

September 10, 2021

First Submitted That Met QC Criteria

September 10, 2021

First Posted (Actual)

September 21, 2021

Study Record Updates

Last Update Posted (Actual)

July 7, 2022

Last Update Submitted That Met QC Criteria

July 4, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 4168/2021/ODDZ-11065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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