NCT03360149

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 4, 2017

Completed
Last Updated

December 4, 2017

Status Verified

October 1, 2017

Enrollment Period

9 months

First QC Date

October 19, 2017

Last Update Submit

November 27, 2017

Conditions

Hemophilia

Keywords

Hemophilia pregnantHemophilia deliveryHemophilia children

Outcome Measures

Primary Outcomes (14)

  • antenatal care in pregnant women carriers of hemophilia

    Frequency of Diagnosis

    during pregnancy

  • labour and delivery procedures

    childbirth procedure type

    day of delivery

  • post-partum care

    treatment type

    day of delivery until 3 month

  • children care

    complication type

    day of delivery until 3 month

  • antenatal care in pregnant women carriers of hemophilia

    description of complications

    9 month (during pregnancy)

  • antenatal care in pregnant women carriers of hemophilia

    patient follow up

    9 month (during pregnancy)

  • labour and delivery procedures

    therapeutic protocol type

    day of delivery

  • labour and delivery procedures

    analgesic type

    day of delivery

  • labour and delivery procedures

    blood loss measurement

    day of delivery

  • post-partum care

    feeding

    day of delivery until 3 month

  • post-partum care

    contraception type

    day of delivery until 3 month

  • post-partum care

    time of menses returns

    day of delivery until 3 month

  • children care

    hemophilia diagnostic

    day of delivery until 3 month

  • children care

    treatment type

    day of delivery until 3 month

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \- Opposition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CHU d'Angers

Angers, 49933, France

Location

CHRU de Brest

Brest, 20609, France

Location

Ch Le Mans

Le Mans, 72037, France

Location

CHU de Nantes

Nantes, 44093, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

CHU de Rennes

Rennes, 35033, France

Location

CHU de TOURS

Tours, 37044, France

Location

Related Publications (1)

  • 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.

    PMID: 32842170DERIVED

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2017

First Posted

December 4, 2017

Study Start

January 5, 2016

Primary Completion

October 5, 2016

Study Completion

October 5, 2017

Last Updated

December 4, 2017

Record last verified: 2017-10

Locations

FR(7)