- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00827463
Early Detection of Anaemia During the Maternity (anémie)
The Early Detection of Anaemia During the Maternity Decreases the Anaemia at the End of the Maternity.
Study Overview
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
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Limousin
-
Limoges, Limousin, France, 87000
- CHU Limoges
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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
|
a blood test will be made.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
primary outcomes: is the rate of heamophilia at the end of the pregnancy.
Time Frame: six months
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vincelot anne, MD, Limoges UH
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- I08009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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