PRADA: Prevalence of Anal Sphincter Defects After Childbirth
Sponsor
Universidad de Zaragoza (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05196620
Collaborator
Hospital Clínico Universitario Lozano Blesa (Other), Instituto de Investigación Sanitaria Aragón (Other)
100
1
32
3.1
Study Details
Study Description
Brief 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-
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prevalence of Anal Sphincter Defects After Childbirth in Primiparous Women
Anticipated Study Start Date
:
May 1, 2022
Anticipated Primary Completion Date
:
Dec 31, 2023
Anticipated Study Completion Date
:
Dec 31, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| EAUS Patients with EAUS pre and postpartum |
Other: Endoanal Ultrasound (EAUS)
Endoanal Ultrasound pre- and postpartum
|
Outcome Measures
Primary Outcome Measures
- Integrity of anal sphincter [4 months]
No defect detected on EAUS
- Defects on anal canal [4 months]
Disruption of any of the anal canal sphincters
Secondary Outcome Measures
- QoL [4 months]
According to a dedicated questionnaire
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Primiparous pregnant patients aged >18 y, evaluated during pregnancy and after childbirth, including both vaginal and cesarean deliveries.
Exclusion Criteria:
- Non primiparous patients and patients with a history of anal surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clinico Lozano Blesa | Zaragoza | Spain | 50009 |
Sponsors and Collaborators
- Universidad de Zaragoza
- Hospital Clínico Universitario Lozano Blesa
- Instituto de Investigación Sanitaria Aragón
Investigators
- Principal Investigator: Jose-M Ramirez, Prof, Universidad de Zaragoza
Study Documents (Full-Text)
None provided.More Information
Publications
- Damon 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.
- Harvey 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. Erratum in: J Obstet Gynaecol Can. 2016 Apr;38(4):421. J Obstet Gynaecol Can. 2016 Apr;38(4):421.
- Johannessen HH, Wibe A, Stordahl A, Sandvik L, Mørkved 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.
- Sultan 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.
- Tejedor P, Plaza J, Bodega-Quiroga I, Ortega-López M, García-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.
- Thomas 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.
Responsible Party:
Jose-M Ramirez,
Prof,
Universidad de Zaragoza
ClinicalTrials.gov Identifier:
NCT05196620
Other Study ID Numbers:
- UZaragoza-3
First Posted:
Jan 19, 2022
Last Update Posted:
Jan 19, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jose-M Ramirez,
Prof,
Universidad de Zaragoza
Additional relevant MeSH terms: