Pelvic Floor DisordersNCT05004402
Pelvic Floor Muscle Function, Pelvic Floor Dysfunction and Diastasis Recti Abdominis in Postpartum Women
An observational study of Pelvic Floor Disorders and Diastasis Recti, run by Żelazna Medical Centre, LLC at 1 site in Poland.
Trial summary
Background: Pregnancy and childbirth are factors that affect a woman's pelvic floor. Pelvic floor disorders (PFD) often occur in the perinatal period. Symptoms and difficulties related to urinary continence and/or pelvic organ prolapse significantly affect daily activities, including physical activity, but also the… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders, Diastasis Recti
- How many people
- 345 participants
- Where
- 1 sitePoland
- Study dates
- 4 Aug 2021to 31 Dec 2023
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Primiparous women after vaginal delivery
Who may be able to join
- Vaginal delivery between 38-42 weeks of pregnancy
- First delivery
- Agreement to participate
- Good command of spoken and written Polish
Who cannot join
- Contraindications for the examination of the pelvic floor muscles (postpartum hematoma of the perineum, extensive perineal swelling, perineal wound dehiscence, bladder catheterization).
- Lack of consent to participate in the study
- Lack of good command of spoken and written Polish
Trial locations and contacts
1 site in 1 country.
About this study
Background: Pregnancy and childbirth are factors that affect a woman's pelvic floor. Pelvic floor disorders (PFD) often occur in the perinatal period. Symptoms and difficulties related to urinary continence and/or pelvic organ prolapse significantly affect daily activities, including physical activity, but also the quality of life and sexual activity. Patient education that includes both the anatomy and function of the pelvic floor, as well as information on the prevention of PFD during pregnancy and postpartum is an important part of the prevention of these dysfunctions. Diastasis recti abdominis (DRA) is another common musculoskeletal issue related to pregnancy and postpartum period. In addition to the cosmetic consequences, it can be associated with abdominal pain, the occurrence of pelvic floor dysfunction and a negative correlation with the image of a woman's own body.
Material and Methods: Primiparous women after vaginal delivery will be invited to this study. The study will consist of three stages. First phase (baseline measurements) will take place at the hospital and the following assessments will be performed: pelvic floor muscle palpation examination (PERFECT scheme, OXFORD scale, Reissing scale), palpation and ultrasound examination of diastasis recti abdominis. After 12-16 weeks postpartum participants will complete questionnaires about pelvic floor dysfunctions and diastasis recti and their impact on quality of life. Third part, 12-16 weeks postpartum, the pelvic floor muscle examination, palpation and ultrasound examination of diastasis recti abdominis will be repeated.
Read more
Objectives: The aim of this study is to assess the function of the pelvic floor muscles, prevalence of pelvic floor dysfunctions and diastasis recti abdominis in the primiparous women postpartum. Our secondary objective will be investigation if there are any prognostics factors during the early postpartum period, that can indicate higher risk of PFD and/or DRA 3 months postpartum.
Expected results: Results of this study will inform about prevalence of pelvic floor dysfunctions and diastasis recti in primiparous women in Poland. Additionally, we hope to obtain predictors suggesting pelvic floor or abdominal muscles dysfunction 3 months postpartum. Prevention of pelvic floor disorders may contribute to the early identification of problems and reduce cost of treatment of unrecognized dysfunction. To our knowledge this will be the first study in this area conducted in Poland.
- Conditions
- Pelvic Floor Disorders, Diastasis Recti
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primiparous women | Primiparous women after vaginal delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palpation examination of pelvic floor muscles with the use of PERFECT Scheme
Assesment of pelvic floor muscles with the use of PERFECT Scheme.
Measured: 24-72 hours postpartum
Palpation examination of pelvic floor muscles with the use of PERFECT Scheme
Assesment of pelvic floor muscles with the use of PERFECT Scheme.
Measured: 12-16 weeks postpartum
Ultrasound measurement of inter-recti distance (IRD)
Measurement of inter-recti distance (IRD) using the ultrasound.
Measured: 24-72 hours postpartum
Ultrasound measurement of inter-recti distance (IRD)
Measurement of inter-recti distance (IRD) using the ultrasound.
Measured: 12-16 weeks postpartum
Polish version of the Pelvic Floor Distress Inventory (PFDI-20)
Condition-specific questionnaire will be used to assess how pelvic floor disorders affect quality of life. It consist of 3 scales, 20 questions. Every scale is scored from 0- no distress to 100 - the greatest distress. The scores from 3 scales are summarized to achieve summary score (0-300).
Measured: 12-16 weeks postpartum
Polish version of the Pelvic Floor Impact Questionnaire short form 7 (PFIQ-7)
Condition-specific questionnaire, will be used to assess impact of pelvic floor disorders on quality of life (daily activities, relationships and emotions). It consists of 3 scales which are scored 0-100. The results from 3 scales are summarized to achieve the summary score (0-300). Higher numbers indicate greater impact.
Measured: 12-16 weeks postpartum
Polish Version of the Female Sexual Function Index (FSFI)
Assessment of sexual function in women, in 6 domains (desire, arousal, lubrication, orgasm, satisfaction, pain) scored 0-6. The summarized maximum score is 36. Results ≤27,50 indicate risk for sexual dysfunction.
Measured: 12-16 weeks postpartum
Secondary outcomes (4)
Palpation evaluation of pelvic muscle tone with Reissing scale
Assessment of muscle tone. Reissing scale for palpation evaluation of muscle tone with use of 7-level grade where -3 means hypotonic, 0 -normotonus and +3 hypertonic muscles.
Measured: 24-72 hours postpartum
Palpation evaluation of pelvic muscle tone with Reissing scale
Assessment of muscle tone. Reissing scale for palpation evaluation of muscle tone with use of 7-level grade where -3 means hypotonic, 0 -normotonus and +3 hypertonic muscles.
Measured: 12-16 weeks postpartum
Palpable measurement of inter-recti distance (IRD)
Palpable measurement of inter-recti distance (IRD) using electronic digital caliper.
Measured: 24-72 hours postpartum
Palpable measurement of inter-recti distance (IRD)
Palpable measurement of inter-recti distance (IRD) using electronic digital caliper.
Measured: 12-16 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start4 Aug 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies 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
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Żelazna Medical Centre, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Małgorzata Starzec-Proserpio, PhD, Principal investigator, Department of Midwifery, Centre of Postgraduate Medical Education, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004402
- Sponsor's protocol ID
- PN/56/2021
- Status last verified
- Apr 2026
- First submitted
- 22 Jul 2021
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Muscle Function, Pelvic Floor Dysfunction and Diastasis Recti Abdominis in Postpartum Women
- ClinicalTrials.gov ID
- NCT05004402
- Acronym / sponsor ID
- PN/56/2021
- Conditions
- Pelvic Floor Disorders, Diastasis Recti
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Żelazna Medical Centre, LLCUniversity, hospital or other
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Aug 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.
Background: Pregnancy and childbirth are factors that affect a woman's pelvic floor. Pelvic floor disorders (PFD) often occur in the perinatal period. Symptoms and difficulties related to urinary continence and/or pelvic organ prolapse significantly affect daily activities, including physical activity, but also the quality of life and sexual activity. Patient education that includes both the anatomy and function of the pelvic floor, as well as information on the prevention of PFD during pregnancy and postpartum is an important part of the prevention of these dysfunctions. Diastasis recti abdominis (DRA) is another common musculoskeletal issue related to pregnancy and postpartum period. In addition to the cosmetic consequences, it can be associated with abdominal pain, the occurrence of pelvic floor dysfunction and a negative correlation with the image of a woman's own body.
Material and Methods: Primiparous women after vaginal delivery will be invited to this study. The study will consist of three stages. First phase (baseline measurements) will take place at the hospital and the following assessments will be performed: pelvic floor muscle palpation examination (PERFECT scheme, OXFORD scale, Reissing scale), palpation and ultrasound examination of diastasis recti abdominis. After 12-16 weeks postpartum participants will complete questionnaires about pelvic floor dysfunctions and diastasis recti and their impact on quality of life. Third part, 12-16 weeks postpartum, the pelvic floor muscle examination, palpation and ultrasound examination of diastasis recti abdominis will be repeated.
Objectives: The aim of this study is to assess the function of the pelvic floor muscles, prevalence of pelvic floor dysfunctions and diastasis recti abdominis in the primiparous women postpartum. Our secondary objective will be investigation if there are any prognostics factors during the early postpartum period, that can indicate higher risk of PFD and/or DRA 3 months postpartum.
Expected results: Results of this study will inform about prevalence of pelvic floor dysfunctions and diastasis recti in primiparous women in Poland. Additionally, we hope to obtain predictors suggesting pelvic floor or abdominal muscles dysfunction 3 months postpartum. Prevention of pelvic floor disorders may contribute to the early identification of problems and reduce cost of treatment of unrecognized dysfunction. To our knowledge this will be the first study in this area conducted in Poland.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primiparous women | – | –Primiparous women after vaginal delivery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Primiparous women after vaginal delivery
Key inclusion criteria (4 listed)
- Vaginal delivery between 38-42 weeks of pregnancy
- First delivery
- Agreement to participate
- Good command of spoken and written Polish
Key exclusion criteria (3 listed)
- Contraindications for the examination of the pelvic floor muscles (postpartum hematoma of the perineum, extensive perineal swelling, perineal wound dehiscence, bladder catheterization).
- Lack of consent to participate in the study
- Lack of good command of spoken and written Polish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Palpation examination of pelvic floor muscles with the use of PERFECT Scheme
Time frame: 24-72 hours postpartum
Assesment of pelvic floor muscles with the use of PERFECT Scheme.
Palpation examination of pelvic floor muscles with the use of PERFECT Scheme
Time frame: 12-16 weeks postpartum
Assesment of pelvic floor muscles with the use of PERFECT Scheme.
Ultrasound measurement of inter-recti distance (IRD)
Time frame: 24-72 hours postpartum
Measurement of inter-recti distance (IRD) using the ultrasound.
Ultrasound measurement of inter-recti distance (IRD)
Time frame: 12-16 weeks postpartum
Measurement of inter-recti distance (IRD) using the ultrasound.
Polish version of the Pelvic Floor Distress Inventory (PFDI-20)
Time frame: 12-16 weeks postpartum
Condition-specific questionnaire will be used to assess how pelvic floor disorders affect quality of life. It consist of 3 scales, 20 questions. Every scale is scored from 0- no distress to 100 - the greatest distress. The scores from 3 scales are summarized to achieve summary score (0-300).
Polish version of the Pelvic Floor Impact Questionnaire short form 7 (PFIQ-7)
Time frame: 12-16 weeks postpartum
Condition-specific questionnaire, will be used to assess impact of pelvic floor disorders on quality of life (daily activities, relationships and emotions). It consists of 3 scales which are scored 0-100. The results from 3 scales are summarized to achieve the summary score (0-300). Higher numbers indicate greater impact.
Polish Version of the Female Sexual Function Index (FSFI)
Time frame: 12-16 weeks postpartum
Assessment of sexual function in women, in 6 domains (desire, arousal, lubrication, orgasm, satisfaction, pain) scored 0-6. The summarized maximum score is 36. Results ≤27,50 indicate risk for sexual dysfunction.
4 secondary outcomes
Palpation evaluation of pelvic muscle tone with Reissing scale
Time frame: 24-72 hours postpartum
Palpation evaluation of pelvic muscle tone with Reissing scale
Time frame: 12-16 weeks postpartum
Palpable measurement of inter-recti distance (IRD)
Time frame: 24-72 hours postpartum
Palpable measurement of inter-recti distance (IRD)
Time frame: 12-16 weeks postpartum
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 16 Apr 2026.
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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.
Małgorzata Starzec-Proserpio, PhD principal investigator
Department of Midwifery, Centre of Postgraduate Medical Education, Warsaw, Poland
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 Pelvic Floor Disorders and Diastasis Recti, run by Żelazna Medical Centre, LLC at 1 site in Poland.
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 4 inclusion and 3 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 16 Apr 2026. 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 Poland. 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?
Palpation examination of pelvic floor muscles with the use of PERFECT Scheme (time frame: 24-72 hours postpartum). The study lists 7 primary outcomes in all. 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 16 Apr 2026.