Clinical trial NCT02823717: Obstetric and Proctology Support of Patients With Perineums Suits
Official title: Obstetric and Proctology Support of Patients With Perineums Suits. Prospective Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstetric Complications
Muscle Tear
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 186
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of change of Bristol Score
timeFrame: 6 months, 1, 2 and 3 years of birth
measure: Assessment of change of anal incontinence score
timeFrame: 6 months, 1, 2 and 3 years of birth
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-Francfe
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: AZRIA Elie, MD
role: PRINCIPAL_INVESTIGATOR
References: