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Prevalence of Anal Sphincter Defects After Childbirth

NCT ID: NCT05196620

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Fecal Incontinence Childbirth Problems

Keywords

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Anal Ultrasound Fecal Incontinence Childbirth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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EAUS

Patients with EAUS pre and postpartum

Endoanal Ultrasound (EAUS)

Intervention Type OTHER

Endoanal Ultrasound pre- and postpartum

Interventions

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Endoanal Ultrasound (EAUS)

Endoanal Ultrasound pre- and postpartum

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clínico Universitario Lozano Blesa

OTHER

Sponsor Role collaborator

Instituto de Investigación Sanitaria Aragón

OTHER

Sponsor Role collaborator

Universidad de Zaragoza

OTHER

Sponsor Role lead

Responsible Party

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Jose-M Ramirez

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jose-M Ramirez, Prof

Role: PRINCIPAL_INVESTIGATOR

Universidad de Zaragoza

Locations

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Hospital Clinico Lozano Blesa

Zaragoza, , Spain

Site Status

Countries

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Spain

Central Contacts

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Jose-M Ramirez, Prof

Role: CONTACT

Phone: +34639776364

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 31325659 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16260538 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27272501 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15981061 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26637088 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28685224 (View on PubMed)

Other Identifiers

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UZaragoza-3

Identifier Type: -

Identifier Source: org_study_id