Clinical Research Directory

Comparing Two Intravenous Iron Treatments for Anemia in Kurdish Pregnant Women

The goal of this clinical trial is to compare two types of intravenous (IV) iron-Ferric Carboxymaltose (FCM) and Iron Sucrose (IS)-to learn which one works better to treat iron deficiency anemia in pregnant women who have a clear medical need for IV iron. It will also learn about the safety of both drugs. The main questions it aims to answer are: 1. Does FCM lead to a higher increase in hemoglobin (blood iron) levels 4 weeks after treatment compared to IS? 2. What medical problems or side effects do women experience with each drug? 3. Does FCM reduce the number of hospital visits and improve women satisfaction? Participants will: 1. Be in their second or third trimester and share the same precise medical indications requiring IV iron (such as severe anemia, no improvement from pills, or being very late in their pregnancy). 2. Be randomly assigned from the start to receive either FCM or IS through an IV, with the total dose calculated based on their body weight and blood tests. 3. Receive FCM in one or more full doses, or receive IS split into multiple smaller sessions up to 3 times a week. 4. Visit the clinic for their assigned infusions and undergo blood tests and satisfaction surveys twice: right before starting treatment and 1 month after receiving the medication.

Maternal Iron Deficiency and Childhood Health

The aim of this prospective observational cohort study is to study maternal iron deficiency and iron deficiency anemia and the use of iron supplements in pregnancy and their impact on the health of the offspring and pregnancy outcomes. All women coming to Tampere University Hospital for prenatal checkups and/or labor are recruited to the study. After giving their consent the mothers fill an online questionnaire about about possible maternal anemia and its diagnosis in pregnancy, iron deficiency and its diagnosis in pregnancy, maternal use of iron supplement or folic acid and it´s timing, about possible other chronic disease and their medications during pregnancy, and whether the mother has got intravenous iron infusions in pregnancy. Mothers also give their permit to use their in-and outpatient data from pregnancy until hospital discharge and to follow the health of their offspring from birth until 7 years of age from in- and outpatient records.We aim to recruit 6000 mother-child-pairs. The health of the offspring (growth, diagnoses, medication, possible therapies, need of support at daycare or school) will be followed for the first month, then at 1,5 years, four years and seven years of age from the patient records. In addition to the cohort study, two nested cohort studies will be performed. The aim of the nested cohort studies is to study the correlation of maternal iron status to the iron status of the child. Secondary aim is to evaluate iron biomarkers, especially reticulocyte hemoglobin, and their reliability to interpret neonatal iron status. A 100 mothers with diagnosed iron deficiency and iron supplementation (p.o. or i.v.) in pregnancy, are recruited to Nested cohort 1. For the nested cohort 2, a 100 mothers with diabetes requiring insulin therapy in pregnancy are recruited. Tor these two cohorts, a 100 mothers without iron deficiency or diabetes will be recruited as controls. Iron status of the mother will be tested before delivery from blood sample. The iron status of the offspring will be checked from umbilical blood, at 2 days of age at the same time other lab tests are taken, at eight months and two and five years of age. In addition to the laboratory tests, parents fill up an electronical questionnaire at eight months, two and five years about the nutrition, sleep, behaviour and cognitive and motor skills of their child. The researchers try to find out, whether iron deficiency in pregnancy has long-term effects on the health and development of the offspring, and how the iron status correlates between the mother and the child, and does it have impact on their sleep, behaviour or skills.