NCT04883385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

October 8, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2022

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

May 5, 2021

Last Update Submit

September 14, 2022

Conditions

Thromboembolic Disease

Keywords

Thromboembolic diseaseThromboprophylaxisPost-partum periodPregnancylow molecular heparin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

    at one year

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

    at one year

Interventions

medical data collectionOTHER

collection of medical data from patients' medical records

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who had given birth at Centre Hospitalier Sud Francilien

You may qualify if:

  • \>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

You may not qualify if:

  • Curative treatment of thrombosis by Low molecular-weight or unfractioned heparin during pregnancy or post-partum period
  • Curative anticoagulant therapy for any cause

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

Location

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Elsa BROCAS, MD

    Centre Hospitalier Sud Francilien

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 12, 2021

Study Start

October 8, 2021

Primary Completion

July 9, 2022

Study Completion

July 9, 2022

Last Updated

September 15, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)