NCT03873571

Brief Summary

According to the World Health Organization (WHO), anemia is the most common disease, affecting \>1.5 billion people worldwide. Furthermore, iron deficiency anemia (IDA) accounts for 50% of cases of anemia. IDA is common during pregnancy and the postpartum period, and can lead to serious maternal and fetal complications. Measurement of serum ferritin has the highest sensitivity and specificity for diagnosis of IDA unless there is a concurrent inflammatory condition. The lower threshold value for hemoglobin (Hb) in pregnant women is \<11 g/dL during the 1st and 3rd trimesters, and \<10.5 g/dL during the 2nd trimester. In postpartum period a Hb concentration \<10 g/dL indicates clinically significant anemia. Oral iron therapy is given as the first-line treatment for IDA.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

March 12, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
3.8 years until next milestone

Study Start

First participant enrolled

December 30, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

March 12, 2019

Last Update Submit

February 14, 2023

Conditions

Pregnancy RelatedPregnancy AnemiaIron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

  • Medication Adherence

    SMAQ (Simplified Medication Adherence Questionnaire) rating

    9 months

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women with anaemia treated with iron succinylate

You may qualify if:

  • Pregnancy
  • Anaemia
  • Iron treatment before 3 months of pregnancy
  • Informed Consent
  • Compliant with study procedures

You may not qualify if:

  • Iron treatment after 3 months of pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iaso Hospital

Athens, Greece

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases
0

Study Design

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

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 13, 2019

Study Start

December 30, 2022

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations

GR(1)