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NCT Number: NCT07407374

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

About this study

his is a prospective observational cohort study conducted in the setting of routine clinical care at Śmietański Hernia Center in Gdańsk (LUX MED Hospital) with collaboration from Medical University of Gdańsk. The study focuses on patient-centered outcomes in women with postpartum abdominal wall insufficiency syndrome (PPAWIS), a condition characterized by variable combinations of abdominal wall dysfunction and psychosocial impact after childbirth.

Participants will complete standardized, validated PROMs capturing quality of life, body image, and sexual function. Assessments will be performed at baseline (at/around qualification for routine care) and at predefined follow-up time points (e.g., 6 and 12 months). Clinical and demographic variables relevant for interpretation (e.g., time since last delivery, BMI, coexisting abdominal wall findings, and type of routine care received) will be recorded in a structured manner.

The study is non-interventional: treatment decisions and clinical management are determined by clinicians and patients according to usual practice and are not assigned by the research protocol. The primary purpose is to quantify baseline burden and describe longitudinal changes in PROMs, and to explore associations between patient-reported outcomes and selected clinical characteristics to inform future standardization of assessment and care pathways.

Data will be collected and stored using pseudonymized study identifiers. Participation is voluntary and can be withdrawn at any time without affecting clinical care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • Able and willing to provide informed consent and complete patient-reported outcome questionnaires at baseline and follow-up

Exclusion criteria

  • 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
  • Participation in another interventional study that could materially affect patient-reported outcomes related to abdominal wall function during the follow-up period

Treatment and study plan

Routine Clinical Care

Other

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.

Primary outcomes

  1. Change in Quality of Life (WHOQOL-BREF)

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

    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

  1. Change in Sexual Function (FSFI)

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

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

  2. Change in Body Image (Body Image scale)

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

    Change from baseline in validated body image questionnaire score (instrument as specified in the study protocol and local language version).

  3. Sustained Change in Quality of Life (WHOQOL-BREF)

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Magdalena Halska

CONTACT

[email protected]

607 870 690

Sponsors and collaborators

Lead sponsor

Swissmed Hospital

Other

Collaborators

  • Medical University of Gdansk
  • Śmietański Hernia Center

Registry information

Official study title

A Prospective Observational Cohort Study of Quality of Life, Body Image, and Sexual Function in Women With Postpartum Abdominal Wall Insufficiency Syndrome (PPAWIS) Using Patient-Reported Outcome Measures

Acronym: EMPOWER

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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