THROM-PP2021: Thromboprophylaxis by Low Molecular Heparin During the Post-partum Period

Sponsor

Centre Hospitalier Sud Francilien (Other)

Overall Status

Recruiting

CT.gov ID

NCT04883385

Collaborator

(none)

1,000

Enrollment

Location

Anticipated Duration (Months)

167.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the current level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period. The institutional protocol is based on national and international guidelines.

Condition or Disease	Intervention/Treatment	Phase
Thromboembolic Disease	Other: medical data collection

Detailed Description

Venous thromboembolism (VTE) became the 4th cause of maternal mortality and the 2nd direct cause of maternal mortality in France.

The re are only few randomized studies on the thromboprophylaxis during the post-partum period. This expose some discrepancy between French guidelines, French Society of Anesthesia & Intensive Care Medecine (SFAR) and National College of French Gynecologists and Obstetricians (CNGOF ).

The duration and adequate dose of low molecular heparin prescriptions are unclear.

The level of adequacy of thromboprophylaxis prescriptions at Centre Hospitalier Sud Francilien with the SFAR recommendations appears to be less than 50 % in a preliminary unpublished study.

Since this assessment, institutional protocol synthesizing thromboprophylaxis guidelines during the post-partum was exposed and validated among medical staff (both anaesthesiologists ang obstetricians).

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Adherence Between Thromboprophylaxis Prescriptions and Guidelines During the Post-partum Period After the Institution of a Local Protocol

Actual Study Start Date :

Oct 8, 2021

Anticipated Primary Completion Date :

Apr 8, 2022

Anticipated Study Completion Date :

Apr 8, 2022

Outcome Measures

Primary Outcome Measures

Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period [at one year]
Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period

Secondary Outcome Measures

Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol after spontaneous or induced vaginal delivery. [at one year]
Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol after spontaneous or induced vaginal delivery.
Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol after a elective or urgent caesar section [at one year]
Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol after a elective or urgent caesar section
causes of non-compliant prescriptions with the institutional protocol. [at one year]
Identify the causes of non-compliant prescriptions with the institutional protocol.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Inclusion Criteria:

18 ages
Who had given birth at Centre Hospitalier Sud Francilien
Hospitalized during the puerperium at Centre Hospitalier Sud Francilien
Being informed of the clinical trial and had offered any opposition for data collection

Exclusion Criteria:

Curative treatment of thrombosis by Low molecular-weight or unfractioned heparin during pregnancy or post-partum period
Curative anticoagulant therapy for any cause