Haemorrhages and Thromboembolic Venous Disease of the Postpartum (HEMOTHEPP)

May 31, 2023 updated by: University Hospital, Brest

Hémorragies et Maladie Veineuse Thromboembolique du Post-partum : Epidémiologie, Etudes Des déterminants Cliniques et Biologiques

The aim of this study is to evaluate the frequencey and the determinants of postpartum major complications (hemorrhage and thrombosis) up to 3 months after delivery in the maternity hospitals of Finistère (Bretagne - France)

Study Overview

Status

Completed

Conditions

Detailed Description

This is an analytical observational prospective multicenter cohort study , conducted on all the maternity hospitals in Finistère (Bretagne - France), with a biological collection.

This protocol allows to study all women at risk of PPH (Postpartum Hemorrhage) and postpartum venous thromboembolic disease, including maternity level 1-3 without case selection. The prospective nature of the study should provide a more detailed analysis of exposures in this particular population of women (risk factors related to the field, childbirth, the postpartum events ...).

The events of interest were PPH and venous thromboembolic disease.

Study Type

Observational

Enrollment (Actual)

20241

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France
        • Clinique KERAUDREN
      • Brest, France, 29609
        • CHRU de Brest - Service de Gynécologie-obstétrique
      • Landerneau, France
        • CH de Landerneau
      • Morlaix, France
        • CH de Morlaix
      • Quimper, France
        • CH Quimper
    • Finistère
      • Carhaix-Plouguer, Finistère, France, 29270
        • CH de Carhaix

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All women admitted for delivery in a maternity Finistère

Description

Inclusion Criteria:

  • Any woman giving birth and supported in one of Gynaecology Obstetrics services of a maternity Finistere.
  • Women ≥ 16 at the time of the collection of non-opposition.
  • For minor patients: understanding the patient and at least one parent.
  • All births ≥ 15 weeks gestation.

Exclusion Criteria:

  • Home Birth
  • Expressed opposition to participation in this study.
  • Childbirth under X.
  • Parent (s) uninformed of the pregnancy of their child.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpartum Hemorrhage
Time Frame: 2 days
Volume of blood loss up to 48 hours after delivery and / or weight compresses collected at delivery, and / or diagnosis of the clinician
2 days
Symptomatic thromboembolic events
Time Frame: 3 month
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: PAN PETESCH Brigitte, Unité d'Hémostase , Centre Régional de traitement de l'hémophilie et des maladies hémorragiques, CHRU de Brest (France)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2015

Primary Completion (Actual)

April 27, 2021

Study Completion (Actual)

April 27, 2021

Study Registration Dates

First Submitted

May 5, 2015

First Submitted That Met QC Criteria

May 11, 2015

First Posted (Estimated)

May 14, 2015

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEMOTHEPP ( RB 13.175)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Venous Thromboembolism

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe