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

Sponsor
Żelazna Medical Centre, LLC (Other)
Overall Status
Recruiting
CT.gov ID
NCT05004402
Collaborator
(none)
345
1
16.9
20.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    345 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pelvic Floor Muscle Function, Pelvic Floor Dysfunction and Diastasis Recti Abdominis in Postpartum Women
    Actual Study Start Date :
    Aug 4, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Primiparous women

    Primiparous women after vaginal delivery

    Outcome Measures

    Primary Outcome Measures

    1. Palpation examination of pelvic floor muscles with the use of PERFECT Scheme [24-72 hours postpartum]

      Assesment of pelvic floor muscles with the use of PERFECT Scheme.

    2. Palpation examination of pelvic floor muscles with the use of PERFECT Scheme [12-16 weeks postpartum]

      Assesment of pelvic floor muscles with the use of PERFECT Scheme.

    3. Ultrasound measurement of inter-recti distance (IRD) [24-72 hours postpartum]

      Measurement of inter-recti distance (IRD) using the ultrasound.

    4. Ultrasound measurement of inter-recti distance (IRD) [12-16 weeks postpartum]

      Measurement of inter-recti distance (IRD) using the ultrasound.

    5. Polish version of the Pelvic Floor Distress Inventory (PFDI-20) [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).

    6. Polish version of the Pelvic Floor Impact Questionnaire short form 7 (PFIQ-7) [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.

    7. Polish Version of the Female Sexual Function Index (FSFI) [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.

    8. Questionnaire Evaluating Diastasis Recti (QUEDIA) [12-16 weeks postpartum]

      Evaluation of signs and symptoms of diastasis of the rectus abdominis.

    Secondary Outcome Measures

    1. Palpation evaluation of pelvic muscle tone with Reissing scale [24-72 hours postpartum]

      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.

    2. Palpation evaluation of pelvic muscle tone with Reissing scale [12-16 weeks postpartum]

      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.

    3. Perineometry of the pelvic floor - vaginal resting pressure [12-16 weeks postpartum]

      Measurement of the vaginal resting pressure.

    4. Perineometry of the pelvic floor - vaginal squeeze pressure. [12-16 weeks postpartum]

      Measurement of the vaginal squeeze pressure.

    5. Pelvic floor dynamometry [12-16 weeks postpartum]

      Measurement of power or force.

    6. Palpable measurement of inter-recti distance (IRD) [24-72 hours postpartum]

      Palpable measurement of inter-recti distance (IRD) using electronic digital caliper.

    7. Palpable measurement of inter-recti distance (IRD) [12-16 weeks postpartum]

      Palpable measurement of inter-recti distance (IRD) using electronic digital caliper.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Vaginal delivery between 38-42 weeks of pregnancy

    • First delivery

    • Agreement to participate

    • Good command of spoken and written Polish

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Sophia's Specialist Hospital Warsaw Poland 01-004

    Sponsors and Collaborators

    • Żelazna Medical Centre, LLC

    Investigators

    • Principal Investigator: Małgorzata Starzec-Proserpio, PhD, Department of Midwifery, Centre of Postgraduate Medical Education, Warsaw, Poland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Żelazna Medical Centre, LLC
    ClinicalTrials.gov Identifier:
    NCT05004402
    Other Study ID Numbers:
    • PN/56/2021
    First Posted:
    Aug 13, 2021
    Last Update Posted:
    Oct 12, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 12, 2021