Patient-Reported Outcomes in Women With Postpartum Abdominal Wall Insufficiency (PPAWIS)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorSwissmed Hospital

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

Qualifiers

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 design

Treatments tested in this trial

  • Routine Clinical Care

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Swissmed Hospital

Lead sponsor

Medical University of Gdansk

Collaborator

Śmietański Hernia Center

Collaborator