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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03873571
Other study ID # 2019-IRPS-EL-96
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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