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

NCT07407374 | Not Yet Recruiting

• 1 other identifier: PPAWIS-01
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diastasis Recti and Weakness of the Linea Alba; Abdominal Wall Defect; Postpartum Complication; Abdominal Wall Anomaly

Keywords

PROMs; postpartum abdominal wall insufficiency; PPAWIS; patient-reported outcomes; sexual function; women's health; core stability; quality of life; abdominal wall reconstruction

Outcome Measures

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.

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

Secondary Outcomes (3)

• Change in Sexual Function (FSFI)

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

• Change in Body Image (Body Image scale)

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

• Sustained Change in Quality of Life (WHOQOL-BREF)

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

Study Arms (1)

Women with PPAWIS (Routine Care)

Participants are women diagnosed with postpartum abdominal wall insufficiency syndrome (PPAWIS) receiving routine clinical care as determined by the treating clinicians and patient preferences. Management include surgical approaches according to usual practice. No intervention is assigned by the research protocol. Patient-reported outcome measures are collected at baseline and during follow-up.

Other: Routine Clinical Care

Interventions

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.

Women with PPAWIS (Routine Care)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swissmed Hospital: lead
• Medical University of Gdansk: collaborator
• Śmietański Hernia Center: collaborator

Related Publications (1)

• Smietanski M, Smietanska IA, Zamkowski M. Post-partum abdominal wall insufficiency syndrome (PPAWIS): lessons learned from a single surgeon's experience based on 200 cases. BMC Surg. 2022 Aug 8;22(1):305. doi: 10.1186/s12893-022-01757-y.

  PMID: 35941642 BACKGROUND

MeSH Terms

Conditions

Diastasis Recti And Weakness Of The Linea Alba

Study Officials

• Maciej Śmietański, Prof.

  Śmietański Hernia Center, LUX MED Hospital in Gdańsk

  PRINCIPAL INVESTIGATOR

• Sylwia Jędrzejewska, MD, PhD

  Polish Sexological Society

  STUDY CHAIR

Central Study Contacts

Magdalena Halska

CONTACT

607 870 690; worldofsurge@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 12, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: IPD will be made available beginning 6 months after publication of the primary results and will remain available for 5 years.
• Access Criteria: Access will be provided through controlled access. Requests must include a research proposal, analysis plan, and documentation of ethics approval (if applicable). Requests will be reviewed by the study steering group. Approved requestors will be required to sign a data use agreement specifying permitted uses, prohibiting re-identification attempts, and requiring secure data storage. Data will be shared in a de-identified format.