Prevalence of Anal Sphincter Defects After Childbirth

Fecal Incontinence Clinical Trial

— PRADA  

Official title:

Prevalence of Anal Sphincter Defects After Childbirth in Primiparous Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05196620
• Other study ID #: UZaragoza-3
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Childbirth Problems
• Fecal Incontinence

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