Ultrasound imaging of the female perineum: the effect of vaginal delivery on pelvic floor dynamics.
S Costantini, F Esposito, C Nadalini...
https://pubmed.ncbi.nlm.nih.gov/16388512/Actively Recruiting
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-03-10
350
Participants Needed
1
Research Sites
52 weeks
Total Duration
This observational clinical trial studies changes in the pelvic floors 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
Monocentric Prospectiv Observational Clinical Trial of Pelvic Floor Biometry During Pregnancy and Puerperium
A
Arsenio Spinillo
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Fondazione IRCCS Policlinico San Matteo di Pavia
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - Up to 10 weeks of pregnancy
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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S Costantini, F Esposito, C Nadalini...
https://pubmed.ncbi.nlm.nih.gov/16388512/Maite Solans-Domènech, Emília Sánchez, Montserrat Espuña-Pons...
https://pubmed.ncbi.nlm.nih.gov/20177295/Fondazione IRCCS Policlinico San Matteo di Pavia
Lead Sponsor