Thromboprophylaxis by Low Molecular Heparin During the Post-partum Period

Thromboembolic Disease Clinical Trial

— THROM-PP2021  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04883385
• Other study ID #: 2021/0016
• Status: Completed
• Start date: October 8, 2021
• Est. completion date: July 9, 2022

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Sud Francilien
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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at Centre Hospitalier Sud Francilien with the SFAR recommendations appears to be less than 50 % in a preliminary unpublished study.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: July 9, 2022
• Est. primary completion date: July 9, 2022
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolic Disease
• Thromboembolism

Intervention

Other:
• medical data collection
collection of medical data from patients' medical records

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil-essonnes Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period	Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period	at one year
Secondary	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 spontaneous or induced vaginal delivery.	at one year
Secondary	Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol after a elective or urgent caesar section	Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol after a elective or urgent caesar section	at one year
Secondary	causes of non-compliant prescriptions with the institutional protocol.	Identify the causes of non-compliant prescriptions with the institutional protocol.	at one year