Monocentric Prospectiv Observational Clinical Trial of Pelvic Floor Biometry During Pregnancy and Puerperium

Launched by FONDAZIONE IRCCS POLICLINICO SAN MATTEO DI PAVIA · Mar 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how pregnancy and after childbirth (the puerperium) affect the pelvic floor, which is the group of muscles and tissues that support the bladder, uterus, and bowel. The researchers want to understand the changes that occur in these structures and how they might lead to issues like urinary incontinence, which is when someone leaks urine unintentionally. By using a non-invasive ultrasound method, the study aims to track these changes throughout pregnancy and after delivery, helping to identify when problems might start and how they can be treated.

To participate in the trial, women between the ages of 18 and 40 who are having a single pregnancy can enroll. They should not have any previous pregnancies, surgeries on the pelvic floor, or certain health conditions like cancer or obesity (a body mass index greater than 40). Participants will undergo ultrasound imaging to measure changes in their pelvic floor and will also answer questions about any urinary symptoms they may experience. This study is ongoing and is designed to provide valuable insights into pelvic health for new mothers.

Gender

FEMALE

Eligibility 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.