deltatrials
Completed OBSERVATIONAL NCT05004402

Pelvic Floor Muscle Function, Pelvic Floor Dysfunction and Diastasis Recti Abdominis in Postpartum Women

Sponsor: Żelazna Medical Centre, LLC

Updated 10 times since 2021 Last updated: Apr 13, 2026 Started: Aug 4, 2021 Primary completion: Dec 31, 2023 Completion: Dec 31, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Diastasis Recti and Pelvic Floor Disorders and is currently completed. Żelazna Medical Centre, LLC leads this study, which shows 10 recorded versions since 2021 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshotNot Yet Recruiting~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshotRecruiting~Nov 2021 – ~Jan 2023 · 14 months · monthly snapshotRecruiting~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshotRecruiting~Feb 2023 – ~May 2023 · 3 months · monthly snapshotRecruiting~May 2023 – ~Jul 2024 · 14 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotRecruiting~Sep 2024 – ~May 2025 · 8 months · monthly snapshotRecruiting~May 2025 – ~Apr 2026 · 12 months · monthly snapshotUnknownApr 17, 2026 – present · 3 months · daily APICompleted

Change History

10 versions recorded
  1. Apr 17, 2026 — Present [daily]

    Completed

    Status: UnknownCompleted

  2. May 2025 — Apr 2026 [monthly]

    Unknown

    Status: RecruitingUnknown

  3. Sep 2024 — May 2025 [monthly]

    Recruiting

  4. Jul 2024 — Sep 2024 [monthly]

    Recruiting

  5. May 2023 — Jul 2024 [monthly]

    Recruiting

Show 5 earlier versions
  1. Feb 2023 — May 2023 [monthly]

    Recruiting

  2. Jan 2023 — Feb 2023 [monthly]

    Recruiting

  3. Nov 2021 — Jan 2023 [monthly]

    Recruiting

  4. Oct 2021 — Nov 2021 [monthly]

    Recruiting

    Status: Not Yet RecruitingRecruiting

  5. Sep 2021 — Oct 2021 [monthly]

    Not Yet Recruiting

    First recorded

Aug 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility 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 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.

Contact Information

Sponsor contact:
  • Żelazna Medical Centre, LLC
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations