Adherence of Iron Succinylate Therapy in Pregnancy

Pregnancy Related Clinical Trial

— ARTEMIS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03873571
• Other study ID #: 2019-IRPS-EL-96
• Status: Withdrawn
• Start date: December 30, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2023
• Source: Elpen Pharmaceutical Co. Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency Anemia
• Pregnancy Anemia
• Pregnancy Related

Locations

Country	Name	City	State
Greece	Iaso Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Elpen Pharmaceutical Co. Inc.

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence	SMAQ (Simplified Medication Adherence Questionnaire) rating	9 months