Patient-Reported Outcomes in Women With Postpartum Abdominal Wall Insufficiency (PPAWIS) (NCT07407374) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Patient-Reported Outcomes in Women With Postpartum Abdominal Wall Insufficiency (PPAWIS)
30 participantsStarted 2026-02-20
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Quality of Life (WHOQOL-BREF)
Timeframe: Baseline and 6 months after baseline (window 5-7 months)