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NCT02443610 Clinical Trial

Haemorrhages and Thromboembolic Venous Disease of the Postpartum

Venous Thromboembolism Clinical Trial

— HEMOTHEPP  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02443610
Other study ID # HEMOTHEPP ( RB 13.175)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 6, 2015
Est. completion date April 27, 2021

Study information
Verified date May 2023
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)

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.

Recruitment information / eligibility
Status Completed
Enrollment 20241
Est. completion date April 27, 2021
Est. primary completion date April 27, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHRU de Brest - Service de Gynécologie-obstétrique Brest
France Clinique Keraudren Brest
France CH de Carhaix Carhaix-Plouguer Finistère
France CH de Landerneau Landerneau
France CH de Morlaix Morlaix
France CH Quimper Quimper

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postpartum Hemorrhage 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
Primary Symptomatic thromboembolic events 3 month
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