NCT03448432

Brief Summary

Anemia during pregnancy occurs in 41% of women. The most common etiology is iron deficiency, but studies to determine prevalence of other causes of anemia in pregnancy are still lacking. However, anemia in pregnancy lead to adverse pregnancy outcomes and increase risk of maternal and fœtal morbidity and mortality. Specific management of anemia is so needed.

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
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

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

First Submitted

Initial submission to the registry

February 22, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

February 27, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2019

Completed
Last Updated

March 5, 2018

Status Verified

February 1, 2018

Enrollment Period

1.7 years

First QC Date

February 22, 2018

Last Update Submit

March 2, 2018

Conditions

Pregnancy Anemia

Keywords

Pregnancy Anemia

Outcome Measures

Primary Outcomes (1)

  • Prevalence of the etiologies of anemias occured during pregnancy

    Anemia in pregnancy is defined as hemoglobin level (Hb) \< 11 g/dL in the first and the third trimesters, and Hb \< 10.5 g/dL in the second trimester.

    from date of inclusion until 6 weeks after delivery

Secondary Outcomes (3)

  • Study of obstetrical complications in women with anemia

    from date of inclusion until delivery

  • Study of the evolution of anemia during pregnancy and postpartum

    from date of inclusion until 6 weeks after delivery

  • Describe the etiological and therapeutic management of pregnancy anemias

    from date of inclusion until 6 weeks after delivery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant woman with anemia

You may qualify if:

  • woman 18-years or older
  • woman with a normal pregnancy
  • anemia with accidental or symptomatic discovery, whatever the term of pregnancy
  • non opposition collected

You may not qualify if:

  • Refuse to participate
  • Stopped pregnancy whatever the term
  • Medical abortion of pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

RECRUITING

Central Study Contacts

Marie-Anne Couturier

CONTACT

0298223421marie-anne.couturier@chu-brest.fr

Study Design

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

Study Record Dates

First Submitted

February 22, 2018

First Posted

February 28, 2018

Study Start

February 27, 2018

Primary Completion

October 27, 2019

Study Completion

December 27, 2019

Last Updated

March 5, 2018

Record last verified: 2018-02

Locations

FR(1)