Haemorrhages and Thromboembolic Venous Disease of the Postpartum

Completed

• Conditions: Postpartum Hemorrhage; Venous Thromboembolism

• Registration Number: NCT02443610
• Lead Sponsor: 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)

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 Timeline

• Study Start: 2015-01-06
• Study First Submitted: 2015-05-05
• Study First Submitted QC: 2015-05-11
• Study First Posted: 2015-05-14
• Primary Completion: 2021-04-27
• Study Completion: 2021-04-27
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-31
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20241

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postpartum Hemorrhage	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
Symptomatic thromboembolic events	3 month

Trial Locations

Locations (6)

Clinique Keraudren; 🇫🇷 Brest, France

CHRU de Brest - Service de Gynécologie-obstétrique; 🇫🇷 Brest, France

CH de Landerneau; 🇫🇷 Landerneau, France

CH de Morlaix; 🇫🇷 Morlaix, France

CH Quimper; 🇫🇷 Quimper, France

CH de Carhaix; 🇫🇷 Carhaix-Plouguer, Finistère, France