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Early Detection of Anaemia During the Maternity (anémie)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00827463
First Posted: January 22, 2009
Last Update Posted: August 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Limoges
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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 ]

Enrollment: 80
Study Start Date: January 2009
Study Completion Date: December 2009
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00827463


Locations
France
CHU limoges
Limoges, Limousin, France, 87000
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Vincelot anne, MD Limoges UH
  More Information

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT00827463     History of Changes
Other Study ID Numbers: I08009
First Submitted: January 20, 2009
First Posted: January 22, 2009
Last Update Posted: August 22, 2016
Last Verified: September 2009

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

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs