Anaemia
Conditions
Interventions
One group will receive ferrous fumarate 200mg intermittent three times a week
(for example on Monday, Wednesday and Friday) and one group will receive
ferrous fumarate 200mg once daily.
Screening
Sponsors
Martini Ziekenhuis
Eligibility
Inclusion criteria
Inclusion criteria: - Pregnant women of 18 years and older - Iron deficiency anaemia (defined as: Anaemia (haemoglobin lower than cut-off value) AND mean corpuscular volume (MCV) 70-85 fl OR ferritin
Exclusion criteria
Exclusion criteria: - Start of iron supplementation at pregnancy duration > 37 weeks (because of the limited time to achieve an increase in haemoglobin). - History of bariatric surgery, inflammatory bowel disease, coeliac disease or Helicobacter pylori infection (because of malabsorption of iron). - Patients who received blood transfusion or parental iron supplementation during the 3 months prior to screening (because of the effect on the haemoglobin level). - Patients with significant bleeding, blood donation or surgery during pregnancy (because of the effect on the haemoglobin level). - Allergy for iron. - Anaemia of other cause, such as a hemoglobinopathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint of the study is the difference in haemoglobin level from baseline to 6 weeks as a continuous variable. A multivariate analysis will be performed with gestational age/trimester at start iron supplementation, the duration of the treatment, use of other supplements, vegetarian diet and the use of proton pump inhibitors or H2 receptor antagonists. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are haemoglobin level at time of delivery, side effects, therapy compliance, term of delivery, birth weight, parenteral iron ante- or postpartum and blood transfusion postpartum. | — |
Countries
Netherlands
Outcome results
None listed