Prevalence of Anal Sphincter Defects After Childbirth

NCT05196620 | Unknown DMC

• 1 other identifier: UZaragoza-3
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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-

Conditions

Fecal Incontinence; Childbirth Problems

Keywords

Anal Ultrasound; Fecal Incontinence; Childbirth

Outcome Measures

Primary Outcomes (2)

• Integrity of anal sphincter

  No defect detected on EAUS

  4 months

• Defects on anal canal

  Disruption of any of the anal canal sphincters

  4 months

Secondary Outcomes (1)

• QoL

  4 months

Study Arms (1)

EAUS

Patients with EAUS pre and postpartum

Other: Endoanal Ultrasound (EAUS)

Interventions

Endoanal Ultrasound (EAUS) OTHER

Endoanal Ultrasound pre- and postpartum

EAUS

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: It is a study about childbirth problems.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primaparous pregnat

You may qualify if:

• Primiparous pregnant patients aged \>18 y, evaluated during pregnancy and after childbirth, including both vaginal and cesarean deliveries.

You may not qualify if:

• Non primiparous patients and patients with a history of anal surgery

Sponsors & Collaborators

• Universidad de Zaragoza: lead
• Hospital Clínico Universitario Lozano Blesa: collaborator
• Instituto de Investigación Sanitaria Aragón: collaborator

Study Sites (1)

Hospital Clinico Lozano Blesa

Zaragoza, 50009, Spain

Location

Related Publications (6)

• 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.

  PMID: 31325659 BACKGROUND

• 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.

  PMID: 16260538 BACKGROUND

• 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.

  PMID: 27272501 BACKGROUND

• 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.

  PMID: 15981061 BACKGROUND

• 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.

  PMID: 26637088 BACKGROUND

• 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.

  PMID: 28685224 BACKGROUND

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jose-M Ramirez, Prof

  Universidad de Zaragoza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose-M Ramirez, Prof

CONTACT

+34639776364; jramirez@unizar.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 19, 2022
• Study Start: June 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: December 31, 2025
• Last Updated: December 4, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)