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Haemorrhages and Thromboembolic Venous Disease of the Postpartum (HEMOTHEPP)

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ClinicalTrials.gov Identifier: NCT02443610
Recruitment Status : Unknown
Verified April 2016 by University Hospital, Brest.
Recruitment status was:  Recruiting
First Posted : May 14, 2015
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:
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)

Condition or disease
Postpartum Hemorrhage Venous Thromboembolism

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
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hémorragies et Maladie Veineuse Thromboembolique du Post-partum : Epidémiologie, Etudes Des déterminants Cliniques et Biologiques
Study Start Date : June 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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. Symptomatic thromboembolic events [ Time Frame: 3 month ]

Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All women admitted for delivery in a maternity Finistère
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443610


Locations
France
CHRU de Brest - Service de Gynécologie-obstétrique Recruiting
Brest, France, 29609
Contact: DUPRE Pierre-François Pierre-François    02 98 22 34 23    pierre-francois.dupre@chu-brest.fr   
Principal Investigator: DUPRE Pierre-François         
Clinique Keraudren Recruiting
Brest, France
Contact: SALNELLE Gilles    02 98,; 34 24 70    gilles.salnelle@wanadoo.fr   
Principal Investigator: SALNELLE Gilles         
CH de Carhaix Recruiting
Carhaix, France
Contact: MARGIS Denis    02 98 99 23 90    denis.margis@chu-brest.fr   
Principal Investigator: MARGIS Denis         
CH de Landerneau Recruiting
Landerneau, France
Contact: COLLET Michel    02 98 22 33 98    michel.collet@chu-brest.fr   
Principal Investigator: COLLET Michel         
CH de Morlaix Recruiting
Morlaix, France
Contact: MULLER Matthieu    02 98 62 60 77    mmuller@ch-morlaix.fr   
Principal Investigator: MULLER Matthieu         
CH Quimper Recruiting
Quimper, France
Contact: JACQUOT Matthieu    02 98 52 61 05    mjacquot@ch-cornouaille.fr   
Principal Investigator: JACQUOT Matthieu         
Sponsors and Collaborators
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)

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02443610     History of Changes
Other Study ID Numbers: HEMOTHEPP ( RB 13.175)
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016

Keywords provided by University Hospital, Brest:
Postpartum Hemorrhage
Venous Thromboembolism
Pregnancy

Additional relevant MeSH terms:
Hemorrhage
Thromboembolism
Venous Thromboembolism
Postpartum Hemorrhage
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage