Observing pelvic floor changes during pregnancy and after childbirth
Monocentric Prospectiv Observational Clinical Trial of Pelvic Floor Biometry During Pregnancy and Puerperium : Relationship with Symptoms Related to Post-partum Pelvic Floor Dysfunction
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 |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Pavia, Pavia) |
| Trial ID | NCT06867341 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with a history of pelvic floor reconstructive surgery, gynecological cancer, or significant obesity may not benefit from this study.
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 performed: While there have been studies on pelvic floor changes, this specific observational approach focusing on pregnancy and postpartum is relatively novel.
Eligibility criteria
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 this trial is running
Pavia, Pavia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.