Diastasis of m. Rectus AbdominisNCT05051176
Prevalence of Diastasis m. Rectus Abdominis in Postpartum Women
An observational study of Diastasis of m. Rectus Abdominis, run by Pavol Jozef Safarik University at 1 site in Slovakia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Diastasis of m. Rectus Abdominis
- What is being tested?
- 2D usg and 3D/4D usg
- How many people
- 150 participants
- Where
- 1 siteSlovakia
- Study dates
- 8 Apr 2021to 23 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women from six weeks to up to 6 months after birth, age over 18 years old.
Who may be able to join
- Women from six weeks to up to 6 months after birth, age over 18 years old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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 .
- Conditions
- Diastasis of m. Rectus Abdominis
- Being tested
- 2D usg and 3D/4D usg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D usg and 3D/4D usgDiagnostic test
IRD distance measured by a linear probe 2D usg. Pelvic floor muscle morphometry measured by 3D/4D usg
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Diastasis Recti Abdominis in Postpartum Women.
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.
Measured: Six weeks to up to 6 months after birth
Secondary outcomes (2)
Relationship of Diastasis Recti Abdominis with urine leakage, pelvic floor muscle function and morphometry in postpartum women.
Occurrence of stress urinary incontinence using the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF).
Measured: Six weeks to up to 6 months after birth.
Relationship between Diastasis Recti Abdominis and back pain in postpartum women.
Occurrence of low back pain using the Oswestry Disability Index (ODI).
Measured: Six weeks to up to 6 months after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start8 Apr 2021
- Primary completion28 Apr 2022
- Study completion23 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastasis of m. Rectus AbdominisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pavol Jozef Safarik University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rastislav Dudič, MD, PhD., Pavol Jozef Safarik University
- Investigators
- Rastislav Dudič, PhD, Principal investigator, Department of Gynecology and Obstetrics, Medical Faculty, PJ Safarik University, Kosice, SlovakiaMagdalena Hagovska, Prof,PhD, Study director, KFBLR, Medical Faculty, PJ Safarik University, Kosice, SlovakiaJan Svihra, Prof,MD,PhD., Study director, Department of Urology, Institution, Comenius University Bratislava, Slovakia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051176
- Sponsor's protocol ID
- 4168/2021/ODDZ-11065
- Status last verified
- Jul 2022
- First submitted
- 10 Sep 2021
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Diastasis m. Rectus Abdominis and Pelvic Floor Muscle Dysfunction in Postpartum Women
- ClinicalTrials.gov ID
- NCT05051176
- Acronym / sponsor ID
- 4168/2021/ODDZ-11065
- Conditions
- Diastasis of m. Rectus Abdominis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Pavol Jozef Safarik UniversityUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women from six weeks to up to 6 months after birth, age over 18 years old.
Key inclusion criteria (1 listed)
- Women from six weeks to up to 6 months after birth, age over 18 years old.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2D usg and 3D/4D usgIRD distance measured by a linear probe 2D usg. Pelvic floor muscle morphometry measured by 3D/4D usg | Diagnostic test | – |
Primary outcome
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.
2 secondary outcomes
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.
Relationship between Diastasis Recti Abdominis and back pain in postpartum women.
Time frame: Six weeks to up to 6 months after birth.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rastislav Dudič, PhD principal investigator
Department of Gynecology and Obstetrics, Medical Faculty, PJ Safarik University, Kosice, Slovakia
Magdalena Hagovska, Prof,PhD study director
KFBLR, Medical Faculty, PJ Safarik University, Kosice, Slovakia
Jan Svihra, Prof,MD,PhD. study director
Department of Urology, Institution, Comenius University Bratislava, Slovakia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diastasis of m. Rectus Abdominis, run by Pavol Jozef Safarik University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Diastasis Recti Abdominis in Postpartum Women. (time frame: Six weeks to up to 6 months after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.