Fecal IncontinencePRADANCT05196620
Prevalence of Anal Sphincter Defects After Childbirth
An observational study of Fecal Incontinence and Childbirth Problems, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
The incidence of obstetric sphincter tears has risen to 15-30% and the prevalence of anal incontinence (AI) symptoms after childbirth may be as high as 40%. The present study aims to evaluate the prevalence of anal sphincter defects after childbirth in primiparous women- Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fecal Incontinence, Childbirth Problems
- What is being tested?
- Endoanal Ultrasound (EAUS)
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2024to 31 Dec 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Primaparous pregnat
Who may be able to join
- Primiparous pregnant patients aged >18 y, evaluated during pregnancy and after childbirth, including both vaginal and cesarean deliveries.
Who cannot join
- Non primiparous patients and patients with a history of anal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Anal Sphincter Defects After Childbirth in Primiparous Women
The incidence of obstetric sphincter tears has risen to 15-30% and the prevalence of anal incontinence (AI) symptoms after childbirth may be as high as 40%. The present study aims to evaluate the prevalence of anal sphincter defects after childbirth in primiparous women-
Read the detailed description
The incidence of sphincter defect in women has raised in recently with current rates as high as 30% after vaginal deliveries. Fecal incontinence could be present at the time of the delivery but it is a real problem longtime after, in women older than 60 years.
It is of great importance not only an early detection but to indicates the best possible management as soon as posible.
The design is a prospective observational study including primiparous woman, without previous anal surgery.
- Conditions
- Fecal Incontinence, Childbirth Problems
- Being tested
- Endoanal Ultrasound (EAUS)
- Keywords
- Anal Ultrasound, Fecal Incontinence, Childbirth
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoanal Ultrasound (EAUS)Other
Endoanal Ultrasound pre- and postpartum
| Study group | Role | What they receive |
|---|---|---|
| EAUS | Patients with EAUS pre and postpartum Receives: Other: Endoanal Ultrasound (EAUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrity of anal sphincter
No defect detected on EAUS
Measured: 4 months
Defects on anal canal
Disruption of any of the anal canal sphincters
Measured: 4 months
Secondary outcomes (1)
QoL
According to a dedicated questionnaire
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clínico Universitario Lozano Blesa, Instituto de Investigación Sanitaria Aragón
- Responsible party
- Principal investigator, Jose-M Ramirez, Universidad de Zaragoza
- Investigators
- Jose-M Ramirez, Prof, Principal investigator, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196620
- Sponsor's protocol ID
- UZaragoza-3
- Acronym
- PRADA
- Status last verified
- Dec 2023
- First submitted
- 29 Dec 2021
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tejedor P, Plaza J, Bodega-Quiroga I, Ortega-Lopez M, Garcia-Olmo D, Pastor C. The Role of Three-Dimensional Endoanal Ultrasound on Diagnosis and Classification of Sphincter Defects After Childbirth. J Surg Res. 2019 Dec;244:382-388. doi: 10.1016/j.jss.2019.06.080. Epub 2019 Jul 17.
PubMed 31325659Sultan AH, Thakar R. Diagnosis of anal sphincter tears to prevent fecal incontinence: a randomized controlled trial. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1108-9; author reply 1109. doi: 10.1097/01.AOG.0000186051.88740.7f. No abstract available.
PubMed 16260538Johannessen HH, Wibe A, Stordahl A, Sandvik L, Morkved S. Do pelvic floor muscle exercises reduce postpartum anal incontinence? A randomised controlled trial. BJOG. 2017 Mar;124(4):686-694. doi: 10.1111/1471-0528.14145. Epub 2016 Jun 7.
PubMed 27272501Damon H, Bretones S, Henry L, Mellier G, Mion F. Long-term consequences of first vaginal delivery-induced anal sphincter defect. Dis Colon Rectum. 2005 Sep;48(9):1772-6. doi: 10.1007/s10350-005-0075-z.
PubMed 15981061Harvey MA, Pierce M, Alter JE, Chou Q, Diamond P, Epp A, Geoffrion R, Harvey MA, Larochelle A, Maslow K, Neustaedter G, Pascali D, Pierce M, Schulz J, Wilkie D, Sultan A, Thakar R; Society of Obstetricians and Gynaecologists of Canada. Obstetrical Anal Sphincter Injuries (OASIS): Prevention, Recognition, and Repair. J Obstet Gynaecol Can. 2015 Dec;37(12):1131-48. doi: 10.1016/s1701-2163(16)30081-0.
PubMed 26637088Thomas GP, Gould LE, Casunuran F, Kumar DA. A retrospective review of 1495 patients with obstetric anal sphincter injuries referred for assessment of function and endoanal ultrasonography. Int J Colorectal Dis. 2017 Sep;32(9):1321-1325. doi: 10.1007/s00384-017-2851-3. Epub 2017 Jul 7.
PubMed 28685224
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Anal Sphincter Defects After Childbirth in Primiparous Women
- ClinicalTrials.gov ID
- NCT05196620
- Acronym / sponsor ID
- PRADA / UZaragoza-3
- Conditions
- Fecal Incontinence, Childbirth Problems
- Keywords
- Anal Ultrasound, Fecal Incontinence, Childbirth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Collaborators
- Hospital Clínico Universitario Lozano Blesa, Instituto de Investigación Sanitaria Aragón
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Jan 2022 (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.
The incidence of obstetric sphincter tears has risen to 15-30% and the prevalence of anal incontinence (AI) symptoms after childbirth may be as high as 40%. The present study aims to evaluate the prevalence of anal sphincter defects after childbirth in primiparous women-
Detailed description
The incidence of sphincter defect in women has raised in recently with current rates as high as 30% after vaginal deliveries. Fecal incontinence could be present at the time of the delivery but it is a real problem longtime after, in women older than 60 years.
It is of great importance not only an early detection but to indicates the best possible management as soon as posible.
The design is a prospective observational study including primiparous woman, without previous anal surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EAUS | – | Other: Endoanal Ultrasound (EAUS)Patients with EAUS pre and postpartum |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primaparous pregnat
Key inclusion criteria (1 listed)
- Primiparous pregnant patients aged >18 y, evaluated during pregnancy and after childbirth, including both vaginal and cesarean deliveries.
Key exclusion criteria (1 listed)
- Non primiparous patients and patients with a history of anal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoanal Ultrasound (EAUS)Endoanal Ultrasound pre- and postpartum | Other | EAUS |
Primary outcome
Integrity of anal sphincter
Time frame: 4 months
No defect detected on EAUS
Defects on anal canal
Time frame: 4 months
Disruption of any of the anal canal sphincters
1 secondary outcome
QoL
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Background: PubMed 31325659Tejedor P, Plaza J, Bodega-Quiroga I, Ortega-Lopez M, Garcia-Olmo D, Pastor C. The Role of Three-Dimensional Endoanal Ultrasound on Diagnosis and Classification of Sphincter Defects After Childbirth. J Surg Res. 2019 Dec;244:382-388. doi: 10.1016/j.jss.2019.06.080. Epub 2019 Jul 17.
- Background: PubMed 16260538Sultan AH, Thakar R. Diagnosis of anal sphincter tears to prevent fecal incontinence: a randomized controlled trial. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1108-9; author reply 1109. doi: 10.1097/01.AOG.0000186051.88740.7f. No abstract available.
- Background: PubMed 27272501Johannessen HH, Wibe A, Stordahl A, Sandvik L, Morkved S. Do pelvic floor muscle exercises reduce postpartum anal incontinence? A randomised controlled trial. BJOG. 2017 Mar;124(4):686-694. doi: 10.1111/1471-0528.14145. Epub 2016 Jun 7.
- Background: PubMed 15981061Damon H, Bretones S, Henry L, Mellier G, Mion F. Long-term consequences of first vaginal delivery-induced anal sphincter defect. Dis Colon Rectum. 2005 Sep;48(9):1772-6. doi: 10.1007/s10350-005-0075-z.
- Background: PubMed 26637088Harvey MA, Pierce M, Alter JE, Chou Q, Diamond P, Epp A, Geoffrion R, Harvey MA, Larochelle A, Maslow K, Neustaedter G, Pascali D, Pierce M, Schulz J, Wilkie D, Sultan A, Thakar R; Society of Obstetricians and Gynaecologists of Canada. Obstetrical Anal Sphincter Injuries (OASIS): Prevention, Recognition, and Repair. J Obstet Gynaecol Can. 2015 Dec;37(12):1131-48. doi: 10.1016/s1701-2163(16)30081-0.
- Background: PubMed 28685224Thomas GP, Gould LE, Casunuran F, Kumar DA. A retrospective review of 1495 patients with obstetric anal sphincter injuries referred for assessment of function and endoanal ultrasonography. Int J Colorectal Dis. 2017 Sep;32(9):1321-1325. doi: 10.1007/s00384-017-2851-3. Epub 2017 Jul 7.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jose-M Ramirez, Prof principal investigator
Universidad de Zaragoza
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 Fecal Incontinence and Childbirth Problems, run by Universidad de Zaragoza at 1 site in Spain.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Dec 2023. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose-M Ramirez, Prof (+34639776364, jramirez@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Integrity of anal sphincter (time frame: 4 months). The study lists 2 primary outcomes in all. 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 NCT05196620, which also lists 6 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 4 Dec 2023.