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Adherence of Iron Succinylate Therapy in Pregnancy

An Observational Study to Examine the Iron Treatment in Pregnant Women With Anaemia

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03873571
Acronym
ARTEMIS
Enrollment
0
Registered
2019-03-13
Start date
2022-12-30
Completion date
2023-12-30
Last updated
2023-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia, Pregnancy Anemia, Pregnancy Related

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.

Detailed description

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. There are several direct and indirect methods to assess adherence to medications, each method has advantages and limits. Many studies have shown that pill counting is more accurate than self-reported adherence.We will investigate the adherence to iron supplementation in pregnant women by using a self-reported adherence questionnaire named SMAQ (Simplified Medication Adherence Questionnaire) Simplified Medication Adherence Questionnaire (SMAQ) Knobel H; Juega J; Carmona A; Kindelan JM; Ruiz I; Gonzalez J; Collazos J; Casado JL; Alonso J; Ocampo A SMAQ is used to assess non-adherent patients. The six-item SMAQ has been developed to assess adherence in HIV-infected patients, and may be applied in most clinical settings.

Interventions

None listed

Sponsors

Elpen Pharmaceutical Co. Inc.
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Iron treatment after 3 months of pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Medication Adherence9 monthsSMAQ (Simplified Medication Adherence Questionnaire) rating

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026