Early Detection of Anaemia During the Maternity

Anemia Clinical Trial

— anémie  

Official title:

The Early Detection of Anaemia During the Maternity Decreases the Anaemia at the End of the Maternity.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827463
• Other study ID #: I08009
• Status: Completed
• Phase: Phase 3
• First received: January 20, 2009
• Last updated: August 19, 2016
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: September 2009
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Estimate the efficiency of a strategy of premature screening of the maternal anaemia during the first quarter of pregnancy versus the usual strategy of screening of the anaemia during the sixth month.

Description:

A part of the patient will have a NFS and dosage of the cast-iron, during the results of the beginning of the pregnancy at the first quarter.

The other part of the patients will have a NFS and at the first quater of the pregnancy.

All the patient will have a NFS at the results of the sixth month of the pregnancy.

A NFS will be done during the results at the end of the pregnancy like we do now.

Then a NFS at 48 hours after the birth. A treatment with iron will be done and according to the results

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Every patient followed at the HME at the beginnig of the pregnancy

Exclusion Criteria:

• pregnency women who don't speak french

• pregnancy women affected by béta thalassemia

• pregnancy woman having had a périconceptionnel treatment against the anaemia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anemia

Intervention

Biological:
• dosage of the NFS and iron
a blood test will be made.

Locations

Country	Name	City	State
France	CHU limoges	Limoges	Limousin

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary outcomes: is the rate of heamophilia at the end of the pregnancy.		six months	No
Secondary	Secondary outcomes: - the percent of treatment of intravenous irons during the pregnancy and the following layers. - the percent of transfusion and the following layers.		6 months	No