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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05196620
Other study ID # UZaragoza-3
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date December 31, 2025

Study information

Verified date December 2023
Source Universidad de Zaragoza
Contact Jose-M Ramirez, Prof
Phone +34639776364
Email jramirez@unizar.es
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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-


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 31, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Endoanal Ultrasound (EAUS)
Endoanal Ultrasound pre- and postpartum

Locations

Country Name City State
Spain Hospital Clinico Lozano Blesa Zaragoza

Sponsors (3)

Lead Sponsor Collaborator
Universidad de Zaragoza Hospital Clínico Universitario Lozano Blesa, Instituto de Investigación Sanitaria Aragón

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. doi: 10.1007/s10350-005-0075-z. — View Citation

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. doi: 10.1016/s1701-2163(16)30081-0. Erratum In: J Obstet Gynaecol Can. 2016 Apr;38(4):421. J Obstet Gynaecol Can. 2016 Apr;38(4):421. — View Citation

Johannessen 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. — View Citation

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. doi: 10.1097/01.AOG.0000186051.88740.7f. No abstract available. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Integrity of anal sphincter No defect detected on EAUS 4 months
Primary Defects on anal canal Disruption of any of the anal canal sphincters 4 months
Secondary QoL According to a dedicated questionnaire 4 months
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