Observing pelvic floor changes during pregnancy and after childbirth
Official title: Monocentric Prospectiv Observational Clinical Trial of Pelvic Floor Biometry During Pregnancy and Puerperium : Relationship with Symptoms Related to Post-partum Pelvic Floor Dysfunction
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT06867341 · Data updated 2026-11-12
This study looks at how pregnancy and childbirth affect the pelvic floor muscles and support structures in women to better understand pelvic floor issues.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 350 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Pavia, Pavia) |
| Status | Recruiting |
| Started | January 17, 2023 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2029 |
| Registry record updated | March 10, 2025 |
| Trial ID | NCT06867341 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women aged 18 to 40 who are fluent in Italian and do not have existing pelvic floor disorders.
✕Probably not a fit
Patients with a history of pelvic floor reconstructive surgery, gynecological cancer, or significant obesity may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the changes in the pelvic floor's muscular and support structures during pregnancy and the postpartum period. It focuses on understanding how pregnancy and childbirth affect pelvic floor disorders, particularly in relation to connective tissue and collagen composition. The study will involve women with confirmed single pregnancies and will monitor various pelvic floor distress and impact scores. Data will be collected from participants who meet specific eligibility criteria, including age and health status.
Why it matters
Potential benefit: If successful, this study could provide insights into pelvic floor health during and after pregnancy, potentially leading to better management of pelvic floor disorders.
How similar studies have gone: While there have been studies on pelvic floor changes, this specific observational approach focusing on pregnancy and postpartum is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * single pregnancy confirmed by ultrasound in the first trimester (within 10 weeks of gestational age), * maternal age between 18 and 40 years, * patients who speak Italian correctly and/or who can perfectly understand what was expressed at the time of enrollment. * spontaneous vaginal births, operative and current cesarean section * patients who do not report urinary and fecal incontinence or pelvic organ prolapse at enrollment. Exclusion Criteria: * previous pregnancy ended with spontaneous vaginal delivery or cesarean section * pelvic floor reconstructive surgery * gynecological cancer * pelvic radiation therapy for previous oncological disease * previous pelvic trauma * known connective tissue disease * body mass index \>40 kg / m2.
Where it's running
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Fondazione IRCCS Policlinico San Matteo, SC Ostetricia e Ginecologia 1
Pavia, Pavia, Italy Recruiting
Study contacts
- Study coordinator: Arsenio Spinillo
- Email: spinillo@smatteo.pv.it
- Phone: +39382503267
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.