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

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

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.

Study Overview

• Status: Completed
• Conditions: Thromboembolic Disease
• Intervention / Treatment: 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at Centre Hospitalier Sud Francilien with the SFAR recommendations appears to be less than 50 % in a preliminary unpublished study.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 Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• France
  • Corbeil-essonnes Cedex, France, 91106
    • Centre Hospitalier Sud Francilien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All patients who had given birth at Centre Hospitalier Sud Francilien

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
causes of non-compliant prescriptions with the institutional protocol.	Identify the causes of non-compliant prescriptions with the institutional protocol.	at one year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Sud Francilien
• Investigators: Principal Investigator: Elsa BROCAS, MD, Centre Hospitalier Sud Francilien

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2021
• Primary Completion (Actual): July 9, 2022
• Study Completion (Actual): July 9, 2022

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Pregnancy; Thromboprophylaxis; Thromboembolic disease; Post-partum period; low molecular heparin
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism
• Other Study ID Numbers: 2021/0016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No