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Completed

NCT Number: NCT02443610

Haemorrhages and Thromboembolic Venous Disease of the Postpartum

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)

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Key information

Conditions

Postpartum Hemorrhage Cardiovascular Diseases Embolism and Thrombosis Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Thromboembolism Urogenital Diseases Uterine Hemorrhage Vascular Diseases Venous Thromboembolism

Age range

16 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CH de Carhaix, Carhaix-Plouguer, Finistère, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: HEMOTHEPP

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
May 14, 2015
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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