ARTEMIS: Adherence of Iron Succinylate Therapy in Pregnancy

Sponsor

Elpen Pharmaceutical Co. Inc. (Industry)

Overall Status

Suspended

CT.gov ID

NCT03873571

Collaborator

(none)

600

Enrollment

Location

Anticipated Duration (Months)

99.8

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 30, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Outcome Measures

Primary Outcome Measures

Medication Adherence [9 months]
SMAQ (Simplified Medication Adherence Questionnaire) rating

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Iaso Hospital	Athens		Greece

Sponsors and Collaborators

Elpen Pharmaceutical Co. Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elpen Pharmaceutical Co. Inc.

ClinicalTrials.gov Identifier:

NCT03873571

Other Study ID Numbers:

2019-IRPS-EL-96

First Posted:

Mar 13, 2019

Last Update Posted:

May 27, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anemia

Anemia, Iron-Deficiency

Study Results

No Results Posted as of May 27, 2022