Early Detection of Anaemia During the Maternity (anémie)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University Hospital, Limoges.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00827463
First received: January 20, 2009
Last updated: September 8, 2009
Last verified: September 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Early Detection of Anaemia During the Maternity Decreases the Anaemia at the End of the Maternity.

Resource links provided by NLM:


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
Experimental: NFS and iron in the first quater
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.
Experimental: No NFS and iron in the first quater
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
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: Marie SENGELEN/ Directrice et de la Recherche clinique et de l'Innovation, direction de la recherche clinique et de l'Innovation
ClinicalTrials.gov Identifier: NCT00827463     History of Changes
Other Study ID Numbers: I08009
Study First Received: January 20, 2009
Last Updated: September 8, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Limoges:
aneamia
aneamia during the maternity

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on October 30, 2014