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Adherence of Iron Succinylate Therapy in Pregnancy (ARTEMIS)

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ClinicalTrials.gov Identifier: NCT03873571
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.

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.

Condition or disease
Pregnancy Related Pregnancy Anemia Iron Deficiency Anemia

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.


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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: An Observational Study to Examine the Iron Treatment in Pregnant Women With Anaemia
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron




Primary Outcome Measures :
  1. Medication Adherence [ Time Frame: 9 months ]
    SMAQ (Simplified Medication Adherence Questionnaire) rating



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women with anaemia treated with iron succinylate
Criteria

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

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Responsible Party: Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier: NCT03873571     History of Changes
Other Study ID Numbers: 2019-IRPS-EL-96
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases