Prevalence of Anal Sphincter Defects After Childbirth | NCT05196620

Studies
Prevalence of Anal Sphincter Defects After Childbirth

NCT05196620

Sponsor

Universidad de Zaragoza

Status

Unknown status

Last Update Posted

Dec 4, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Fecal Incontinence
Childbirth Problems

Interventions

Endoanal Ultrasound (EAUS)

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2024Estimated

Primary Completion Date

Jan 1, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Dec 29, 2021

First Submission Date that Met QC Criteria

Jan 13, 2022

First Posted Date

Jan 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2023

Last Update Posted Date

Dec 4, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jose-M Ramirez, Prof, Universidad de ZaragozaPrincipal Investigator

Lead Sponsor

Universidad de ZaragozaOTHER

Collaborators

Name	Class
Hospital Clínico Universitario Lozano Blesa	OTHER
Instituto de Investigación Sanitaria Aragón	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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-

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EAUS		Patients with EAUS pre and postpartum	Other: Endoanal Ultrasound (EAUS)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoanal Ultrasound (EAUS)	Other	Endoanal Ultrasound pre- and postpartum	EAUS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
QoL	According to a dedicated questionnaire	4 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

It is a study about childbirth problems.

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primaparous pregnat

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jose-M Ramirez, Prof	Contact	+34639776364		jramirez@unizar.es

Overall Officials

Name	Affiliation	Role
Jose-M Ramirez, Prof	Universidad de Zaragoza	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinico Lozano Blesa		Zaragoza		50009	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31325659	Background	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.
16260538	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.

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases