Actively Recruiting

Age: 18Years +
FEMALE
Healthy Volunteers
ID06867341

Monocentric Prospective Observational Clinical Trial of Pelvic Floor Biometry During Pregnancy and Puerperium Relationship with Symptoms Related to Post-partum Pelvic Floor Dysfunction

Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-03-10

350

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This observational clinical trial studies changes in the pelvic floor's muscles, connective tissue, and support structures during pregnancy and the postpartum period. It aims to understand how pregnancy and childbirth affect pelvic floor function and the development of symptoms like urinary incontinence and pelvic organ prolapse. The study addresses the lack of prospective data on when pelvic tissue changes begin during pregnancy and how these changes progress into the puerperium. Participants are pregnant women monitored using non-invasive transperineal pelvic floor ultrasound at key times: baseline (first trimester), second trimester, third trimester, and six weeks after delivery. The study combines ultrasound imaging with clinical assessments and validated urinary symptom questionnaires to evaluate pelvic floor biometry and function over time. During the study, women will undergo pelvic floor measurements and complete symptom questionnaires at each timepoint. Researchers will analyze these data to correlate anatomical changes with symptoms related to pelvic floor dysfunction after childbirth. The total participation includes follow-up until six weeks postpartum, allowing detailed insight into the progression and recovery of pelvic floor structures after pregnancy.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Single pregnancy confirmed by ultrasound in the first trimester (within 10 weeks gestation)
  • Maternal age between 18 and 40 years
  • Ability to speak and understand Italian well
  • Includes spontaneous vaginal births, operative, and current cesarean section deliveries
  • No urinary or fecal incontinence or pelvic organ prolapse at enrollment
Not Eligible

You will not qualify if you...

  • Previous pregnancy ended with vaginal delivery or cesarean section
  • History of pelvic floor reconstructive surgery
  • Diagnosis of gynecological cancer
  • Previous pelvic radiation therapy for cancer
  • Previous pelvic trauma
  • Known connective tissue disease
  • Body mass index over 40 kg/m2

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 10 weeks of pregnancy

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - From baseline through six weeks after delivery

Participants undergo pelvic floor biometry assessments during pregnancy and after delivery to observe changes and relationships with postpartum pelvic floor dysfunction symptoms.

4 visits (baseline, second trimester, third trimester, six weeks postpartum)

Trial Site Locations

Total: 1 location

1

Fondazione IRCCS Policlinico San Matteo, SC Ostetricia e Ginecologia 1

Pavia, Pavia, Italy, 27100

Actively Recruiting

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Research Team

A

Arsenio Spinillo

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Frequently Asked Questions

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Published Research Related To This Trial

Urinary and anal incontinence during pregnancy and postpartum: incidence, severity, and risk factors.

Maite Solans-Domènech, Emília Sánchez, Montserrat Espuña-Pons...

https://pubmed.ncbi.nlm.nih.gov/20177295