Obstetric and Proctology Support of Patients With Perineums Suits

NCT ID: NCT02823717

Last Updated: 2023-04-27

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

UNKNOWN

Total Enrollment

186 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2023-12-31

Brief Summary

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Perineal tear grade III and IV are relatively common (1-10% of deliveries depending on the series), and are a source of potentially serious complications, even long time after delivery (especially disorders of anal continence, psychological trauma). If a number of risk factors are well described, the support arrangements at the time of delivery and the characteristics of the review Proctological remote delivery and its relationship to the clinical status of patients is little known and rarely studied.

In maternity wards of the hospital Saint Joseph Paris and Cochin-Port Royal group, patients with a diagnosis of severe perineal tear was made are taken following load with common rules, both for the immediate repair for the remote monitoring. Patients of both sites are indeed encouraged to consult in proctology consultation in Saint Joseph 4-6 months of birth.

The same support on both sites allows to consider the creation of a relatively homogeneous cohort in terms of support and consider an important recruitment. Moreover, the geographical proximity of the inclusions sites (maternity) with proctology service is likely to limit the risk of lost sight of.

Detailed Description

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Main objective / secondary:

Describe exactly the operational management of severe perineal tear (grade III and IV), their context and the factors associated with them occurring, the results of clinical and paraclinical proctology examination carried away from the birth, and study their relationship with the clinical status of patients at 6 months, 1, 2 and 3 years of confinement.

Methodology :

Type prospective, multicentre, non-interventional Study duration: 6 years

Conditions

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Obstetric Complications Muscle Tear

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* All patients over 18 years
* Affiliated to the national system of social security,
* Giving birth during the period of inclusion of the St. Joseph site or Port Royal for whom the diagnosis of severe perineal tear was done.

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AZRIA Elie, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Hôpital Saint-Joseph

Locations

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Groupe Hospitalier Paris Saint Joseph

Paris, Ile-de-Francfe, France

Site Status

Countries

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France

Other Identifiers

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PERINEE COMPLET

Identifier Type: -

Identifier Source: org_study_id

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