NCT00827463

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 22, 2016

Status Verified

September 1, 2009

Enrollment Period

11 months

First QC Date

January 20, 2009

Last Update Submit

August 19, 2016

Conditions

Anemia

Keywords

aneamiaaneamia during the maternity

Outcome Measures

Primary Outcomes (1)

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

    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.

    6 months

Study Arms (2)

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.

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

Biological: dosage of the NFS and iron

Interventions

dosage of the NFS and ironBIOLOGICAL

a blood test will be made.

NFS and iron in the first quaterNo NFS and iron in the first quater

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Every patient followed at the HME at the beginnig of the pregnancy

You may not qualify if:

  • pregnency women who don't speak french
  • pregnancy women affected by béta thalassemia
  • pregnancy woman having had a périconceptionnel treatment against the anaemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU limoges

Limoges, Limousin, 87000, France

Location

MeSH Terms

Conditions

Anemia

Interventions

Iron

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Vincelot anne, MD

    Limoges UH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2009

First Posted

January 22, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

August 22, 2016

Record last verified: 2009-09

Locations

FR(1)