Adherence of Iron Succinylate Therapy in Pregnancy

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

Sponsors

Lead Sponsor: Elpen Pharmaceutical Co. Inc.

Source 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.

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.

Overall Status Not yet recruiting
Start Date September 1, 2020
Completion Date September 30, 2021
Primary Completion Date September 30, 2021
Study Type Observational
Primary Outcome
Measure Time Frame
Medication Adherence 9 months
Enrollment 600
Condition
Eligibility

Sampling Method: Non-Probability Sample

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Healthy Volunteers: No

Verification Date

July 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Acronym ARTEMIS
Study Design Info

Observational Model: Other

Time Perspective: Prospective

Source: ClinicalTrials.gov