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

This trial does not accept healthy volunteers

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 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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Routine Clinical Care

    Other intervention

    No 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

30 Participants
are divided into 1 treatment group
Group A: Women with PPAWIS (Routine Care)1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 6 months after baseline (window 5-7 months)

Secondary outcomes

1

Change in Sexual Function (FSFI)

Change from baseline in Female Sexual Function Index (FSFI) total score (and domains, if applicable).

Time frame
Baseline and 6 months after baseline (window 5-7 months)
2

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).

Time frame
Baseline and 6 months after baseline (window 5-7 months)
3

Sustained Change in Quality of Life (WHOQOL-BREF)

Change from baseline in WHOQOL-BREF at long-term follow-up.

Time frame
Baseline and 12 months after baseline (window 11-13 months)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Swissmed Hospital

Lead sponsor

Medical University of Gdansk

Collaborator

Śmietański Hernia Center

Collaborator

This trial is not recruiting at the moment. You can still explore other options: