Pregnancy Related Clinical Trial
— ARTEMISOfficial title:
An Observational Study to Examine the Iron Treatment in Pregnant Women With Anaemia
Verified date | February 2023 |
Source | Elpen Pharmaceutical Co. Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
Greece | Iaso Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
Elpen Pharmaceutical Co. Inc. |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Medication Adherence | SMAQ (Simplified Medication Adherence Questionnaire) rating | 9 months |
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