Early Detection of Anaemia During the Maternity - Full Text View

Sponsored by:	University Hospital, Limoges
Information provided by:	University Hospital, Limoges
ClinicalTrials.gov Identifier:	NCT00827463

Purpose

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.

Condition	Intervention	Phase
Anemia	Biological: dosage of the NFS and iron	Phase III

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	The Early Detection of Anaemia During the Maternity Decreases the Anaemia at the End of the Maternity.

Resource links provided by NLM:

MedlinePlus related topics: Anemia

U.S. FDA Resources

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:

primary outcomes: is the rate of heamophilia at the end of the pregnancy. [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary outcomes: - the percent of treatment of intravenous irons during the pregnancy and the following layers. - the percent of transfusion and the following layers. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
NFS and iron in the first quater: Experimental first arm: dosage NFS and iron during the beginning of the pregnancy then in the sixth month of pregnancy then in th delivery.	Biological: dosage of the NFS and iron a blood test will be made.
No NFS and iron in the first quater: Experimental second arm: dosage NFS and iron during the sixth month of pregnancy then in th delivery. No dosage of NFS and iron during the beginning of the pregnancy	Biological: dosage of the NFS and iron a blood test will be made.

Detailed 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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827463

Locations

France, LIMOUSIN
CHU limoges	Recruiting
limoges, LIMOUSIN, France, 87000
Contact: VINCELOT anne, MD 0555056691 drc@chu-limoges.fr

Sponsors and Collaborators

University Hospital, Limoges

Investigators

Principal Investigator:

Vincelot anne, MD

Limoges UH

More Information

No publications provided

Responsible Party:	direction de la recherche clinique et de l'Innovation ( Marie SENGELEN/ Directrice et de la Recherche clinique et de l'Innovation )
Study ID Numbers:	I08009
Study First Received:	January 20, 2009
Last Updated:	September 8, 2009
ClinicalTrials.gov Identifier:	NCT00827463 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Limoges:

aneamia
aneamia during the maternity

Study placed in the following topic categories:

Hematologic Diseases
Anemia
Iron

Additional relevant MeSH terms:

Hematologic Diseases
Anemia

ClinicalTrials.gov processed this record on September 11, 2009