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
Recruitment status was Recruiting
Sponsor:
University Hospital, Limoges
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00827463
First received: January 20, 2009
Last updated: September 8, 2009
Last verified: September 2009
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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
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 Iron Trace Elements |
Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013