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Completed

NCT Number: NCT04883385

Thromboprophylaxis by Low Molecular Heparin During the Post-partum Period

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

About this study

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at Centre Hospitalier Sud Francilien with the SFAR recommendations appears to be less than 50 % in a preliminary unpublished study.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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

medical data collection

Other

collection of medical data from patients' medical records

Primary outcomes

  1. Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period

    Time frame: at one year

    Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period

Secondary outcomes

  1. Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol after spontaneous or induced vaginal delivery.

    Time frame: at one year

    Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol after spontaneous or induced vaginal delivery.

  2. Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol after a elective or urgent caesar section

    Time frame: at one year

    Level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol after a elective or urgent caesar section

  3. causes of non-compliant prescriptions with the institutional protocol.

    Time frame: at one year

    Identify the causes of non-compliant prescriptions with the institutional protocol.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Official study title

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

Acronym: THROM-PP2021

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 12, 2021
Registry last updated
Sep 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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