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

Hemophilia Clinical Trial

— ECHANGE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03360149
• Other study ID #: ECHANGE
• Status: Completed
• Phase: N/A
• First received: October 19, 2017
• Last updated: November 27, 2017
• Start date: January 5, 2016
• Est. completion date: October 5, 2017

Study information

• Verified date: October 2017
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 5, 2017
• Est. primary completion date: October 5, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult

• Hemophilia A or B

• Pregnancy between 2014 and 2016

Exclusion Criteria:

• Opposition

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A

Locations

Country	Name	City	State
France	CHU d'Angers	Angers
France	CHRU de Brest	Brest
France	Ch Le Mans	Le Mans
France	CHU de Nantes	Nantes
France	CHU de Poitiers	Poitiers
France	CHU de Rennes	Rennes
France	CHU de TOURS	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

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