About this trial
Postpartum abdominal wall insufficiency syndrome (PPAWIS) is a multidimensional condition that may affect physical function, quality of life, body image, and sexual health in women after childbirth. Anatomical findings alone do not fully explain symptom burden or patient experience.
This prospective observational cohort study will collect validated patient-reported outcome measures (PROMs) from women with PPAWIS receiving routine care. PROMs will be assessed at baseline and during follow-up to describe symptom burden and changes over time. The study aims to improve understanding of the patient-centered impact of PPAWIS and to support development of standardized assessment pathways in clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female, age 18-65 years
Postpartum status: at least 6 months after last delivery
Clinical diagnosis of postpartum abdominal wall insufficiency syndrome (PPAWIS), defined by abdominal wall dysfunction symptoms and/or significant quality-of-life impact, with supportive findings on physical examination and/or imaging (e.g., diastasis recti and/or related abdominal wall insufficiency features)
Receiving routine clinical care for PPAWIS at the study site (surgical)
Disqualifiers
Current pregnancy
Planned pregnancy during the follow-up period (up to 12 months), if expected to interfere with outcome assessment
Inability to complete questionnaires due to cognitive impairment or insufficient language proficiency in the validated questionnaire language version
Severe uncontrolled psychiatric condition that, in the investigator's opinion, would prevent informed consent or reliable questionnaire completion
Trial population
Women aged 18-65 years with postpartum abdominal wall insufficiency syndrome (PPAWIS), evaluated and managed in routine clinical care at the study site. Participants are assessed using validated patient-reported outcome measures at baseline and during follow-up to characterize symptom burden and changes over time.
Trial design
Cohort
Prospective
Treatments tested in this trial
Routine Clinical Care
Other interventionNo intervention is assigned by the research protocol. Clinical management is determined by clinicians and patients according to usual practice; the study collects patient-reported outcome measures longitudinally.
Treatment groups
Trial outcomes
Primary outcomes
Change in Quality of Life (WHOQOL-BREF)
Change from baseline in the WHOQOL-BREF domain scores and overall quality of life/health items in women with PPAWIS receiving routine care.
Secondary outcomes
Change in Sexual Function (FSFI)
Change from baseline in Female Sexual Function Index (FSFI) total score (and domains, if applicable).
Change in Body Image (Body Image scale)
Change from baseline in validated body image questionnaire score (instrument as specified in the study protocol and local language version).
Sustained Change in Quality of Life (WHOQOL-BREF)
Change from baseline in WHOQOL-BREF at long-term follow-up.
Locations
Sponsors and contacts
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Swissmed Hospital
Lead sponsor
Medical University of Gdansk
Collaborator
Śmietański Hernia Center
Collaborator
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