The goal of this feasibility study is to better understand the use of intravenous (IV) and oral iron supplementation to mitigate iron deficient anemia in pregnant women in the UK before and after giving birth. The knowledge gained from this study will inform further research and strategy on IV Iron use in low and middle income countries (LMIC) where oral iron is the standard of care, and for the UK population will provide insights into anemia occurrence in pregnancy and how it is treated. The study will also evaluate the suitability of CPRD primary care data linked to Hospital Episode Statistics (HES) to investigate treatment of anemia in pregnancy.
This study will investigate use of intravenous and oral iron to treat anemia during and after pregnancy.
Descriptive statistics will be calculated to address the following questions.
1. What is the prevalence of anemia in pregnancy and postpartum by trimester, by severity and over time?
2. What is the prevalence of iron-deficiency anemia (IDA) in pregnancy and postpartum?
3. What is the prevalence of postpartum hemorrhage and blood transfusion?
4. What proportion of women diagnosed with mild, moderate, and severe anemia were treated with oral and IV iron in pregnancy and postpartum?
5. What is the average/median and range of Hg and ferritin concentrations among women treated with IV iron and oral iron in pregnancy and postpartum? Can we stratify by IDA vs. any anemia?
6. What is the timing of IV iron administration in pregnancy and postpartum (e.g. trimester, postdelivery)?
7. Describe the characteristics of patients with IV iron use in pregnancy and postpartum (e.g. maternal age, race, BMI, oral iron supplement use, etc.)?
8. Exporatory objective: Can we use CPRD data to ascertain the IV iron products administered (e.g. ferric carboxymaltose, ferric derisomaltose), dosages and associated costs (using British NF/drug tariff data)?
Data and summary statistics will be tabulated by the different conditions, severities and time periods. Given that the strata for tabulation are broad (trimesters, mild/moderate/severe anemia, etc.), we do not foresee any issue with unintentional (deductive) disclosure of patients. Any counts <5 patients will be suppressed in line with CPRD small cell count policy.
HES data is required for IV iron administration and postpartum hemorrhage/blood transfusion, as well as patient-level IMD data to stratify counts by SES. This study will evaluate whether CPRD-HES data can be used to further study treatment of anemia in pregnancy to the benefit of patients in England and Wales.
Each of the following outcomes will be studied as specified in the technical summary and will be identified and differentiated by using the appropriate medical and product codes. Anemia; Iron-deficiency anemia; Postpartum hemorrhage; Postpartum blood transfusion
Anemia severity will be defined as mild (Hgb: 10.0-10.9 g/dL), moderate (Hgb: 7.0-9.9 g/dL), severe (Hgb < 7.0 g/dL) during pregnancy and mild (Hgb: 11.0-11.9 g/dL), moderate (Hgb: 8.0-10.9 g/dL), severe (Hgb < 8.0 g/dL) postpartum based on test data.
Statistics will be tabulated for each trimester of pregnancy as well as immediate postpartum (<48 hours post-delivery) and the first 180 days postpartum.
Karen Cuenco - Chief Investigator - The Gates Foundation
Ryan Hafen - Corresponding Applicant - Preva Group, LLC
CPRD GOLD Pregnancy Register;HES Admitted Patient Care;Patient Level Index of Multiple Deprivation