HemophiliaECHANGENCT03360149
Health Practice of Hemophilia Patiente Care During Pregnancy, Delivery and Newborn Children
An observational study of Hemophilia, run by University Hospital, Brest at 7 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hemophilia
- How many people
- 35 participants
- Where
- 7 sitesFrance
- Study dates
- 5 Jan 2016to 5 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: - Adult with Hemophilia A or B during Pregnancy, Delivery and Newborn Children
Who may be able to join
- Adult
- Hemophilia A or B
- Pregnancy between 2014 and 2016
Who cannot join
- Opposition
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU d'Angers
Angers, 49933
CHRU de Brest
Brest, 20609
Ch Le Mans
Le Mans, 72037
CHU de Nantes
Nantes, 44093
CHU de Poitiers
Poitiers, 86021
CHU de Rennes
Rennes, 35033
CHU de TOURS
Tours, 37044
About this study
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.
- Conditions
- Hemophilia
- Keywords
- Hemophilia pregnant, Hemophilia delivery, Hemophilia children
- Medical subject headings
- Hemophilia A
What is being measured
The primary outcome is the main question the study is designed to answer.
antenatal care in pregnant women carriers of hemophilia
Frequency of Diagnosis
Measured: during pregnancy
labour and delivery procedures
childbirth procedure type
Measured: day of delivery
post-partum care
treatment type
Measured: day of delivery until 3 month
children care
complication type
Measured: day of delivery until 3 month
antenatal care in pregnant women carriers of hemophilia
description of complications
Measured: 9 month (during pregnancy)
antenatal care in pregnant women carriers of hemophilia
patient follow up
Measured: 9 month (during pregnancy)
labour and delivery procedures
therapeutic protocol type
Measured: day of delivery
labour and delivery procedures
analgesic type
Measured: day of delivery
labour and delivery procedures
blood loss measurement
Measured: day of delivery
post-partum care
feeding
Measured: day of delivery until 3 month
post-partum care
contraception type
Measured: day of delivery until 3 month
post-partum care
time of menses returns
Measured: day of delivery until 3 month
children care
hemophilia diagnostic
Measured: day of delivery until 3 month
children care
treatment type
Measured: day of delivery until 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start5 Jan 2016
- Primary completion5 Oct 2016
- Study completion5 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360149
- Sponsor's protocol ID
- ECHANGE
- Acronym
- ECHANGE
- Status last verified
- Oct 2017
- First submitted
- 19 Oct 2017
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nau A, Gillet B, Guillet B, Beurrier P, Ardillon L, Cussac V, Guillou S, Raj L, Trossaert M, Horvais V, Bayart S, Potin J, Rose J, Macchi L, Couturaud F, Lacut K, Pan-Petesch B. Bleeding complications during pregnancy and delivery in haemophilia carriers and their neonates in Western France: An observational study. Haemophilia. 2020 Nov;26(6):1046-1055. doi: 10.1111/hae.14117. Epub 2020 Aug 25.
PubMed 32842170
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Practice of Hemophilia Patiente Care During Pregnancy, Delivery and Newborn Children
- ClinicalTrials.gov ID
- NCT03360149
- Acronym / sponsor ID
- ECHANGE / ECHANGE
- Conditions
- Hemophilia
- Keywords
- Hemophilia pregnant, Hemophilia delivery, Hemophilia children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 5 Jan 2016 (actual)
- Primary completion
- 5 Oct 2016 (actual)
- Study completion
- 5 Oct 2017 (actual)
- First posted
- 4 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Adult with Hemophilia A or B during Pregnancy, Delivery and Newborn Children
Key inclusion criteria (3 listed)
- Adult
- Hemophilia A or B
- Pregnancy between 2014 and 2016
Key exclusion criteria (1 listed)
- Opposition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
antenatal care in pregnant women carriers of hemophilia
Time frame: during pregnancy
Frequency of Diagnosis
labour and delivery procedures
Time frame: day of delivery
childbirth procedure type
post-partum care
Time frame: day of delivery until 3 month
treatment type
children care
Time frame: day of delivery until 3 month
complication type
antenatal care in pregnant women carriers of hemophilia
Time frame: 9 month (during pregnancy)
description of complications
antenatal care in pregnant women carriers of hemophilia
Time frame: 9 month (during pregnancy)
patient follow up
labour and delivery procedures
Time frame: day of delivery
therapeutic protocol type
labour and delivery procedures
Time frame: day of delivery
analgesic type
labour and delivery procedures
Time frame: day of delivery
blood loss measurement
post-partum care
Time frame: day of delivery until 3 month
feeding
post-partum care
Time frame: day of delivery until 3 month
contraception type
post-partum care
Time frame: day of delivery until 3 month
time of menses returns
children care
Time frame: day of delivery until 3 month
hemophilia diagnostic
children care
Time frame: day of delivery until 3 month
treatment type
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
- Derived from this study: PubMed 32842170Nau A, Gillet B, Guillet B, Beurrier P, Ardillon L, Cussac V, Guillou S, Raj L, Trossaert M, Horvais V, Bayart S, Potin J, Rose J, Macchi L, Couturaud F, Lacut K, Pan-Petesch B. Bleeding complications during pregnancy and delivery in haemophilia carriers and their neonates in Western France: An observational study. Haemophilia. 2020 Nov;26(6):1046-1055. doi: 10.1111/hae.14117. Epub 2020 Aug 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia, run by University Hospital, Brest at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antenatal care in pregnant women carriers of hemophilia (time frame: during pregnancy). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03360149, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2017.