Health Practice of Hemophilia Patiente Care During Pregnancy, Delivery and Newborn Children (ECHANGE)

November 27, 2017 updated by: University Hospital, Brest

Prenancy and specialy delivery for hemophilia mother and her children possibly hemophilia is risked.

Diagnostical of hemophilia pregnan is the first difficulty but patients with hemorrhagic menstruation without etiology known, hemorrhagic complication during a chirurgical procedure or during previously pregnancy currently are examine in Haemostasis consultation.

None French recommendation specifie for health practice of these hemophilia patients exists. However, Anglo-Saxon recommendations are published in 2011.

The objective of this study is to realize a French investigation of health practice about hemophilia care of these patients and to compare them with the English reference table.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • CHU d'Angers
      • Brest, France, 20609
        • CHRU de Brest
      • Le Mans, France, 72037
        • CH Le Mans
      • Nantes, France, 44093
        • Chu De Nantes
      • Poitiers, France, 86021
        • CHU de Poitiers
      • Rennes, France, 35033
        • CHU de Rennes
      • Tours, France, 37044
        • CHU de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

- Adult with Hemophilia A or B during Pregnancy, Delivery and Newborn Children

Description

Inclusion Criteria:

  • Adult
  • Hemophilia A or B
  • Pregnancy between 2014 and 2016

Exclusion Criteria:

- Opposition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
antenatal care in pregnant women carriers of hemophilia
Time Frame: during pregnancy
Frequency of Diagnosis
during pregnancy
labour and delivery procedures
Time Frame: day of delivery
childbirth procedure type
day of delivery
post-partum care
Time Frame: day of delivery until 3 month
treatment type
day of delivery until 3 month
children care
Time Frame: day of delivery until 3 month
complication type
day of delivery until 3 month
antenatal care in pregnant women carriers of hemophilia
Time Frame: 9 month (during pregnancy)
description of complications
9 month (during pregnancy)
antenatal care in pregnant women carriers of hemophilia
Time Frame: 9 month (during pregnancy)
patient follow up
9 month (during pregnancy)
labour and delivery procedures
Time Frame: day of delivery
therapeutic protocol type
day of delivery
labour and delivery procedures
Time Frame: day of delivery
analgesic type
day of delivery
labour and delivery procedures
Time Frame: day of delivery
blood loss measurement
day of delivery
post-partum care
Time Frame: day of delivery until 3 month
feeding
day of delivery until 3 month
post-partum care
Time Frame: day of delivery until 3 month
contraception type
day of delivery until 3 month
post-partum care
Time Frame: day of delivery until 3 month
time of menses returns
day of delivery until 3 month
children care
Time Frame: day of delivery until 3 month
hemophilia diagnostic
day of delivery until 3 month
children care
Time Frame: day of delivery until 3 month
treatment type
day of delivery until 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2016

Primary Completion (Actual)

October 5, 2016

Study Completion (Actual)

October 5, 2017

Study Registration Dates

First Submitted

October 19, 2017

First Submitted That Met QC Criteria

November 27, 2017

First Posted (Actual)

December 4, 2017

Study Record Updates

Last Update Posted (Actual)

December 4, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECHANGE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemophilia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe