Haemorrhages and Thromboembolic Venous Disease of the Postpartum

NCT ID: NCT02443610

Last Updated: 2023-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20241 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-06

Study Completion Date

2021-04-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postpartum Hemorrhage Venous Thromboembolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

PAN PETESCH Brigitte

Role: PRINCIPAL_INVESTIGATOR

Unité d'Hémostase , Centre Régional de traitement de l'hémophilie et des maladies hémorragiques, CHRU de Brest (France)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CH de Carhaix

Carhaix-Plouguer, Finistère, France

Site Status

CHRU de Brest - Service de Gynécologie-obstétrique

Brest, , France

Site Status

Clinique Keraudren

Brest, , France

Site Status

CH de Landerneau

Landerneau, , France

Site Status

CH de Morlaix

Morlaix, , France

Site Status

CH Quimper

Quimper, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Anouilh F, de Moreuil C, Tremouilhac C, Jacquot M, Salnelle G, Bellec V, Touffet N, Cornec C, Muller M, Dupre PF, Bellot C, Morcel K, Joliff DL, Drugmanne G, Gelebart E, Lucier S, Nowak E, Bihan L, Couturaud F, Tromeur C, Moigne EL, Pan-Petesch B. Family history of postpartum hemorrhage is a risk factor for postpartum hemorrhage after vaginal delivery: results from the French prospective multicenter Haemorrhages and Thromboembolic Venous Disease of the Postpartum cohort study. Am J Obstet Gynecol MFM. 2023 Sep;5(9):101062. doi: 10.1016/j.ajogmf.2023.101062. Epub 2023 Jun 19.

Reference Type DERIVED
PMID: 37343695 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HEMOTHEPP ( RB 13.175)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Twin Pregnancy Cohort
NCT05144321 ACTIVE_NOT_RECRUITING
rhuFVIIa in Post-partum Hemorrhage
NCT00370877 COMPLETED PHASE4