Back to results

Early Detection of Anaemia During the Maternity (anémie)

Primary Purpose

Anemia

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

dosage of the NFS and iron

About this trial

This is an interventional diagnostic trial for Anemia focused on measuring aneamia, aneamia during the maternity

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

CHU limoges

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

NFS and iron in the first quater

No NFS and iron in the first quater

Arm Description

first arm: dosage NFS and iron during the beginning of the pregnancy then in the sixth month of pregnancy then in th delivery.

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

Outcomes

Primary Outcome Measures

primary outcomes: is the rate of heamophilia at the end of the pregnancy.

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.

Full Information

NCT ID

NCT00827463

First Posted

January 20, 2009

Last Updated

August 19, 2016

Sponsor

University Hospital, Limoges

1. Study Identification

Unique Protocol Identification Number

NCT00827463

Brief Title

Early Detection of Anaemia During the Maternity

Acronym

anémie

Official Title

The Early Detection of Anaemia During the Maternity Decreases the Anaemia at the End of the Maternity.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Limoges

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia

Keywords

aneamia, aneamia during the maternity

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NFS and iron in the first quater

Arm Type

Experimental

Arm Description

first arm: dosage NFS and iron during the beginning of the pregnancy then in the sixth month of pregnancy then in th delivery.

Arm Title

No NFS and iron in the first quater

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

dosage of the NFS and iron

Intervention Description

a blood test will be made.

Primary Outcome Measure Information:

Title

primary outcomes: is the rate of heamophilia at the end of the pregnancy.

Time Frame

six months

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vincelot anne, MD

Organizational Affiliation

Limoges UH

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU limoges

City

Limoges

State/Province

Limousin

ZIP/Postal Code

87000

Country

France

12. IPD Sharing Statement

Learn more about this trial

Early Detection of Anaemia During the Maternity

We'll reach out to this number within 24 hrs