Clinical trial NCT04883385: Thromboprophylaxis by Low Molecular Heparin During the Post-partum Period
Official title: Adherence Between Thromboprophylaxis Prescriptions and Guidelines During the Post-partum Period After the Institution of a Local Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thromboembolic Disease
Keywords: Thromboembolic disease
Thromboprophylaxis
Post-partum period
Pregnancy
low molecular heparin
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who had given birth at Centre Hospitalier Sud Francilien

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.

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at Centre Hospitalier Sud Francilien with the SFAR recommendations appears to be less than 50 % in a preliminary unpublished study.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).

Eligibility criteria: 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

Primary outcomes:
measure: Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period
timeFrame: at one year
Secondary outcomes:
measure: Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol after spontaneous or induced vaginal delivery.
timeFrame: at one year
measure: Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol after a elective or urgent caesar section
timeFrame: at one year
measure: causes of non-compliant prescriptions with the institutional protocol.
timeFrame: at one year
Other outcomes:
Locations:
city: Corbeil-essonnes Cedex
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Elsa BROCAS, MD
role: PRINCIPAL_INVESTIGATOR
References: