Pelvic Floor DisordersNCT06867341
Monocentric Prospectiv Observational Clinical Trial of Pelvic Floor Biometry During Pregnancy and Puerperium
An observational study of Pelvic Floor Disorders and Pelvic Floor Distress and Impact Scores, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Pregnancy, childbirth and the puerperium determine significant changes in the muscular, fascial and support structures of the pelvic floor. These changes, both physiological (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders, Pelvic Floor Distress and Impact Scores
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jan 2023to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be consecutively enrolled in the three trimesters of pregnancy and in the puerperium, nulliparous, and who did not report pelvic static disorders at the time of enrollment (fecal and urinary incontinence and symptoms of genital prolapse).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo, SC Ostetricia e Ginecologia 1
Pavia, Pavia, 27100
Arsenio Spinillo, MD, +390382503267, spinillo@smatteo.pv.it
About this study
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
Pregnancy, childbirth and the puerperium determine significant changes in the muscular, fascial and support structures of the pelvic floor. These changes, both physiological (i.e. dictated by the adaptations that pregnancy determines at the level of the connective tissue, collagen and pelvic-perineal muscular structures) and the changes induced by the passage of the fetus through the birth canal (obstetric lacerations, episiotomy and muscle avulsions) cause a weakening of the pelvic support structures with the possible onset of dysfunctional symptoms, which are not only common in old age, but become evident already in childbearing age. Previous studies on the composition of connective tissue show significant changes in the collagen component both in continent women and in those who experience stress urinary incontinence. These changes are revealed in approximately 24% of the population that suffers from urinary incontinence. Collagen is the main component of the endopelvic fascia. During pregnancy, the hormonal influence typical of this phase determines significant changes in the mechanical properties of the connective tissue and muscle fibers of the levator ani, which tend to hypertrophy and lengthen. This may also explain why cesarean delivery, elective or after the onset of labor, is not fully protective against the development of pelvic floor dysfunction. However, pelvic floor changes may have occurred before delivery and may not necessarily be related to labor and delivery itself. Incontinence, mostly temporary in pregnancy, must be interpreted as the result of these factors in addition to the increased pressure on the urethrovesical junction caused by the gravid uterus. Stretching of connective tissues beyond their physiological limits during labor, resulting in levator ani injury and/or possible neurogenic stretch damage, occurs in the majority of women who give birth vaginally, but in most women, muscle hypertrophy and nerve fiber adaptation compensate for this pathological pattern. In a minority (5-20%) of women, major levator ani defects and neurogenic lesion may lead to irreversible changes in pelvic floor function. Pelvic floor imaging after pregnancy has improved the understanding of the etiology of pelvic floor disorders in animal models. Patients who already present with pelvic static dysfunction and urinary incontinence during pregnancy tend to develop the same problems in the puerperium. However, to date it is not known what moment in pregnancy these changes in the pelvic tissue begin and that cause the progressive change in the myo-connective components of pregnancy. The lack of prospective cohort studies of pregnant and postpartum subjects does not allow a conclusive opinion on this topic. Pelvic floor ultrasound performed transpeineally, useful for evaluating pelvic biometry, is a non-invasive method and well tolerated by the patient, not only in postpartum but also during pregnancy. A previous study examined pelvic floor changes during pregnancy, reporting how the progression of pregnancy determines changes in the anatomical components of the pelvic floor, without however correlating the data with the puerperium and the longer-term outcomes of these changes. We did not identify any previously published studies that attempted to comprehensively assess biometric changes of the pelvic floor during pregnancy and postpartum using not only ultrasound imaging, but also clinical assessment and validated urinary symptom questionnaires.
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PREGNAANT WOMEN | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
pelvic floor biometry
evaluate the association between the biometry of the pelvic floor and the presence of symptoms such as urinary and fecal incontience, pelvic weight and vaginal congestion typical of genital prolapse, related to pelvic-perineal dysfunction at the check-up carried out 6 months after delivery. Specifically, the following end-points will be evaluated: pelvic hiatus area, measured in the last trimester of pregnancy and in the post-partum
Measured: baseline, at second trimester of pregnancy, at third trimester of pregnancy, six weeks after delivery
Secondary outcomes (1)
pelvic floor biometry
- time course of the pelvic hiatus area
- time course of the anteroposterior diameter
- time course of the transverse diameter of the pelvic hiatus
- time course of the presence/intensity of symptoms based on the score obtained in the PDFI questionnaire
Measured: baseline, at second trimester of pregnancy, at third trimester of pregnancy, six weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start17 Jan 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arsenio Spinillo, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867341
- Sponsor's protocol ID
- PavPel
- Status last verified
- Feb 2025
- First submitted
- 4 Mar 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Solans-Domenech M, Sanchez E, Espuna-Pons M; Pelvic Floor Research Group (Grup de Recerca del Sol Pelvia; GRESP). Urinary and anal incontinence during pregnancy and postpartum: incidence, severity, and risk factors. Obstet Gynecol. 2010 Mar;115(3):618-628. doi: 10.1097/AOG.0b013e3181d04dff.
PubMed 20177295Costantini S, Esposito F, Nadalini C, Lijoi D, Morano S, Lantieri P, Mistrangelo E. Ultrasound imaging of the female perineum: the effect of vaginal delivery on pelvic floor dynamics. Ultrasound Obstet Gynecol. 2006 Feb;27(2):183-7. doi: 10.1002/uog.2663.
PubMed 16388512
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06867341
- Acronym / sponsor ID
- PavPel
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pregnancy, childbirth and the puerperium determine significant changes in the muscular, fascial and support structures of the pelvic floor. These changes, both physiological (i.e. dictated by the adaptations that pregnancy determines at the level of the connective tissue, collagen and pelvic-perineal muscular structures) and the changes induced by the passage of the fetus through the birth canal (obstetric lacerations, episiotomy and muscle avulsions) cause a weakening of the pelvic support structures with the possible onset of dysfunctional symptoms, which are not only common in old age, but become evident already in childbearing age. Previous studies on the composition of connective tissue show significant changes in the collagen component both in continent women and in those who experience stress urinary incontinence. These changes are revealed in approximately 24% of the population that suffers from urinary incontinence. Collagen is the main component of the endopelvic fascia. During pregnancy, the hormonal influence typical of this phase determines significant changes in the mechanical properties of the connective tissue and muscle fibers of the levator ani, which tend to hypertrophy and lengthen. This may also explain why cesarean delivery, elective or after the onset of labor, is not fully protective against the development of pelvic floor dysfunction. However, pelvic floor changes may have occurred before delivery and may not necessarily be related to labor and delivery itself. Incontinence, mostly temporary in pregnancy, must be interpreted as the result of these factors in addition to the increased pressure on the urethrovesical junction caused by the gravid uterus. Stretching of connective tissues beyond their physiological limits during labor, resulting in levator ani injury and/or possible neurogenic stretch damage, occurs in the majority of women who give birth vaginally, but in most women, muscle hypertrophy and nerve fiber adaptation compensate for this pathological pattern. In a minority (5-20%) of women, major levator ani defects and neurogenic lesion may lead to irreversible changes in pelvic floor function. Pelvic floor imaging after pregnancy has improved the understanding of the etiology of pelvic floor disorders in animal models. Patients who already present with pelvic static dysfunction and urinary incontinence during pregnancy tend to develop the same problems in the puerperium. However, to date it is not known what moment in pregnancy these changes in the pelvic tissue begin and that cause the progressive change in the myo-connective components of pregnancy. The lack of prospective cohort studies of pregnant and postpartum subjects does not allow a conclusive opinion on this topic. Pelvic floor ultrasound performed transpeineally, useful for evaluating pelvic biometry, is a non-invasive method and well tolerated by the patient, not only in postpartum but also during pregnancy. A previous study examined pelvic floor changes during pregnancy, reporting how the progression of pregnancy determines changes in the anatomical components of the pelvic floor, without however correlating the data with the puerperium and the longer-term outcomes of these changes. We did not identify any previously published studies that attempted to comprehensively assess biometric changes of the pelvic floor during pregnancy and postpartum using not only ultrasound imaging, but also clinical assessment and validated urinary symptom questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PREGNAANT WOMEN | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be consecutively enrolled in the three trimesters of pregnancy and in the puerperium, nulliparous, and who did not report pelvic static disorders at the time of enrollment (fecal and urinary incontinence and symptoms of genital prolapse).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pelvic floor biometry
Time frame: baseline, at second trimester of pregnancy, at third trimester of pregnancy, six weeks after delivery
evaluate the association between the biometry of the pelvic floor and the presence of symptoms such as urinary and fecal incontience, pelvic weight and vaginal congestion typical of genital prolapse, related to pelvic-perineal dysfunction at the check-up carried out 6 months after delivery. Specifically, the following end-points will be evaluated: pelvic hiatus area, measured in the last trimester of pregnancy and in the post-partum
1 secondary outcome
pelvic floor biometry
Time frame: baseline, at second trimester of pregnancy, at third trimester of pregnancy, six weeks after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Background: PubMed 20177295Solans-Domenech M, Sanchez E, Espuna-Pons M; Pelvic Floor Research Group (Grup de Recerca del Sol Pelvia; GRESP). Urinary and anal incontinence during pregnancy and postpartum: incidence, severity, and risk factors. Obstet Gynecol. 2010 Mar;115(3):618-628. doi: 10.1097/AOG.0b013e3181d04dff.
- Background: PubMed 16388512Costantini S, Esposito F, Nadalini C, Lijoi D, Morano S, Lantieri P, Mistrangelo E. Ultrasound imaging of the female perineum: the effect of vaginal delivery on pelvic floor dynamics. Ultrasound Obstet Gynecol. 2006 Feb;27(2):183-7. doi: 10.1002/uog.2663.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Disorders and Pelvic Floor Distress and Impact Scores, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arsenio Spinillo (+39382503267, spinillo@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pelvic floor biometry (time frame: baseline, at second trimester of pregnancy, at third trimester of pregnancy, six weeks after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06867341, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.