Clinical trial Recruiting at 1 site Observational Ages 18 and up Women only

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 typeObservational
Ages18 Years and up
SexWomen only
Enrollment350 (estimated)
SponsorFondazione IRCCS Policlinico San Matteo di Pavia
Academic / other
Drugs / interventionsradiation
Locations1 site (Pavia, Pavia)
StatusRecruiting
StartedJanuary 17, 2023
Main results expectedDecember 31, 2028
Study endsDecember 31, 2029
Registry record updatedMarch 10, 2025
Trial IDNCT06867341 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

  • Fondazione IRCCS Policlinico San Matteo, SC Ostetricia e Ginecologia 1
    Pavia, Pavia, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.