AnemiaPhase 3anémieNCT00827463
Early Detection of Anaemia During the Maternity
A Phase 3 study testing dosage of the NFS and iron in people with Anemia, run by University Hospital, Limoges at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Anemia
- What is being tested?
- dosage of the NFS and iron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Every patient followed at the HME at the beginnig of the pregnancy
Who cannot join
- pregnency women who don't speak french
- pregnancy women affected by béta thalassemia
- pregnancy woman having had a périconceptionnel treatment against the anaemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Early Detection of Anaemia During the Maternity Decreases the Anaemia at the End of the Maternity.
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.
Read the 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
- Conditions
- Anemia
- Being tested
- dosage of the NFS and iron
- Keywords
- aneamia, aneamia during the maternity
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dosage of the NFS and ironBiological
a blood test will be made.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: dosage of the NFS and iron |
| 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 Receives: Biological: dosage of the NFS and iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcomes: is the rate of heamophilia at the end of the pregnancy.
Measured: six months
Secondary outcomes (1)
Secondary outcomes: - the percent of treatment of intravenous irons during the pregnancy and the following layers. - the percent of transfusion and the following layers.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincelot anne, MD, Principal investigator, Limoges UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827463
- Sponsor's protocol ID
- I08009
- Acronym
- anémie
- Status last verified
- Sep 2009
- First submitted
- 20 Jan 2009
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Early Detection of Anaemia During the Maternity Decreases the Anaemia at the End of the Maternity.
- ClinicalTrials.gov ID
- NCT00827463
- Acronym / sponsor ID
- anémie / I08009
- Conditions
- Anemia
- Keywords
- aneamia, aneamia during the maternity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NFS and iron in the first quater | Experimental | Biological: dosage of the NFS and ironfirst arm: dosage NFS and iron during the beginning of the pregnancy then in the sixth month of pregnancy then in th delivery. |
| No NFS and iron in the first quater | Experimental | Biological: dosage of the NFS and ironsecond 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Every patient followed at the HME at the beginnig of the pregnancy
Key exclusion criteria (3 listed)
- pregnency women who don't speak french
- pregnancy women affected by béta thalassemia
- pregnancy woman having had a périconceptionnel treatment against the anaemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dosage of the NFS and irona blood test will be made. | Biological | NFS and iron in the first quater, No NFS and iron in the first quater |
Primary outcome
primary outcomes: is the rate of heamophilia at the end of the pregnancy.
Time frame: six months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincelot anne, MD principal investigator
Limoges UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dosage of the NFS and iron in people with Anemia, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary outcomes: is the rate of heamophilia at the end of the pregnancy. (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016; AzTrials last refreshed its copy on 7 Nov 2026.