NCT03176147

Brief Summary

Iron deficiency anemia is the leading cause of anemia during pregnancy, which can still reach 10 to 20% of pregnant women in developed countries, with potentially serious consequences for the child. Systematic iron supplementation remains controversial. This study aims to identify in the first trimester of pregnancy clinical and biological predictive factors for the occurrence of iron deficiency anemia in the third trimester of pregnancy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
865

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2017

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

June 5, 2017

Status Verified

May 1, 2017

Enrollment Period

1.6 years

First QC Date

May 30, 2017

Last Update Submit

June 1, 2017

Conditions

Keywords

AnemiaPregnancyHepcidineIron

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin value

    in the third trimestry of pregnancy

Secondary Outcomes (3)

  • Rate of clinical and biological factors per patient

    at the first trimestry of pregnancy

  • Rate of demographics and clinical factors per patient

    at the first trimestry of pregnancy

  • Rate of biological factors per patient

    at the first trimestry of pregnancy

Study Arms (1)

Pregnant women

Pregnant women are included during the ultrasound of T1. Written consent will be sought after delivery of the information notice.

Other: Iron deficiency anemia

Interventions

The prevalence of iron deficiency anemia is determined at T3 (after 34 SA). The predictive factors for this anemia will be sought according to the data collected in T1.

Pregnant women

Eligibility Criteria

Age15 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The women were screened at the maternity clinic of the gynecology-obstetrics department of CHU Estaing in Clermont-Ferrand, France.

You may qualify if:

  • Pregnant women in the first trimester between 11SA and 13 SA + 6 days
  • A written agreement is needed

You may not qualify if:

  • Women who do not know enough about reading and writing French to answer questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

Location

MeSH Terms

Conditions

Anemia, Iron-DeficiencyAnemia

Condition Hierarchy (Ancestors)

Anemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Marc RUIVARD, MD, PhD

    CHU de Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 5, 2017

Study Start

November 12, 2015

Primary Completion

June 1, 2017

Study Completion

January 1, 2018

Last Updated

June 5, 2017

Record last verified: 2017-05

Locations