St. Sophia's Specialist Hospital
Warsaw, 01-004, Poland
NCT Number: NCT05004402
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.
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Notify Me18 year–45 year
Female
Observational
Warsaw, 01-004, Poland
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 24-72 hours postpartum
Assesment 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.
Time frame: 24-72 hours postpartum
Measurement of inter-recti distance (IRD) using the ultrasound.
Time frame: 12-16 weeks postpartum
Measurement of inter-recti distance (IRD) using the ultrasound.
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).
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 24-72 hours postpartum
Palpable measurement of inter-recti distance (IRD) using electronic digital caliper.
Time frame: 12-16 weeks postpartum
Palpable measurement of inter-recti distance (IRD) using electronic digital caliper.
Żelazna Medical Centre, LLC
Other
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