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Thromboprophylaxis by Low Molecular Heparin During the Post-partum Period

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04883385
Acronym
THROM-PP2021
Enrollment
1000
Registered
2021-05-12
Start date
2021-10-08
Completion date
2022-07-09
Last updated
2022-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboembolic Disease

Keywords

Thromboembolic disease, Thromboprophylaxis, Post-partum period, Pregnancy, low molecular heparin

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at Centre Hospitalier Sud Francilien with the SFAR recommendations appears to be less than 50 % in a preliminary unpublished study.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

Interventions

collection of medical data from patients' medical records

Sponsors

Centre Hospitalier Sud Francilien
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum periodat one yearLevel of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period

Secondary

MeasureTime frameDescription
Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol after spontaneous or induced vaginal delivery.at one yearLevel 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 sectionat one yearLevel 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 yearIdentify the causes of non-compliant prescriptions with the institutional protocol.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026