An observational study in Diastasis Recti and Weakness of the Linea Alba, Abdominal Wall Defect and Postpartum Complication, sponsored by Swissmed Hospital. Not yet recruiting. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Swissmed Hospital · Observational
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.
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.
Swissmed Hospital is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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)
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)
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)
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)
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data (IPD) underlying the results reported in publications will be shared, including baseline and follow-up patient-reported outcome measure scores and a limited set of key clinical and demographic variables necessary to reproduce analyses (e.g., age range, BMI category, time since last delivery, presence of relevant abdominal wall findings). Direct identifiers will not be shared. Data will be pseudonymized and assessed for re-identification risk prior to release. Data will be shared for research purposes related to postpartum abdominal wall dysfunction and patient-reported outcomes, subject to approval of a qualified research proposal and execution of a data use agreement.
Supporting information: Study protocol, Statistical analysis plan, 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.
Start is estimated for Feb 2026; primary completion for Oct 2026, 7 months later.
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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Diastasis Recti And Weakness Of The Linea Alba
Swissmed Hospital