- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05051176
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
Conditions
Intervention / Treatment
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
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-
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Košice, Slovakia, 04011
- PJ Šafárik University
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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.
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Six weeks to up to 6 months after birth
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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.
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Occurrence of stress urinary incontinence using the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF).
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Six weeks to up to 6 months after birth.
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Relationship between Diastasis Recti Abdominis and back pain in postpartum women.
Time Frame: Six weeks to up to 6 months after birth.
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Occurrence of low back pain using the Oswestry Disability Index (ODI).
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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.
Sponsor
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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