Thromboprophylaxis by Low Molecular Heparin During the Post-partum Period

Completed

• Conditions: Thromboembolic Disease

• Registration Number: NCT04883385
• Lead Sponsor: 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at Centre Hospitalier Sud Francilien with the SFAR recommendations appears to be less than 50 % in a preliminary unpublished study.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).

Study Timeline

• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-12
• Study Start: 2021-10-08
• Primary Completion: 2022-07-09
• Study Completion: 2022-07-09
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-14
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1000

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-essonnes Cedex, France