To compare the efficacy, side effects and therapy compliance of intermittent (three times a week) versus daily oral iron supplementation for anaemia in pregnancy attributed to iron deficiency.
ID
Source
Brief title
Condition
- Anaemias nonhaemolytic and marrow depression
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Iron deficiency anaemia in pregnancy is common and the standard treatment is
iron supplementation once or twice daily. But there is no evidence for the
optimal dose of iron supplementation in pregnancy. In non-pregnant women
intermittent oral iron supplementation on alternate days is proven to have a
similar effect on haemoglobin levels as iron supplementation daily with less
side effects. In pregnancy the need and absorption of iron is physiologically
higher. Therefore the optimal dose may differ from non-pregnant women.
The adverse effects of iron supplementation, which are mainly gastrointestinal
effects, seem to be related to the dose of iron supplementation. These effects
often already exist physiologically in pregnancy and may increase with the use
of iron supplementation. Therefore, a lower dose would be preferable in
pregnancy if the effectiveness is similar.
In this study intermittent dosage of iron supplementation three times a week
will be compared to daily dosage in anaemic pregnant women due to iron
deficiency. Our hypothesis is that intermittent oral iron supplementation is at
least as effective as iron supplementation once daily and will give less
adverse effects.
Study objective
To compare the efficacy, side effects and therapy compliance of intermittent
(three times a week) versus daily oral iron supplementation for anaemia in
pregnancy attributed to iron deficiency.
Study design
Single-centre, non-inferiority, open-label randomised controlled trial.
Intervention
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 for anaemia during the pregnancy will be done according the local
protocol in the first trimester and at a gestational age of 30 weeks. In women
at risk for anaemia extra haemoglobin level will be measured at a gestational
age of 20 weeks.
When a patient is eligible for the study she will be computer-randomised.
Haemoglobin levels will be measured every 6 weeks after the start of the
supplementation until the delivery. Side effects and therapy compliance will be
evaluated with an interview.
Study burden and risks
In this study we follow the local protocol, which means subjects do not have
additional hospital visits or blood tests. The only difference is the dosage of
oral supplementation. Because ferrous fumarate is registered as a therapy for
iron deficiency anaemia and both dosages are already used in daily practice
there are no additional risks for the subjects.
If the haemoglobin level of a subject does not rise or when it is drops below
90.2 g/L (5.6 mmol/L) after at least 6 weeks of sufficient iron supplementation
the subject will receive extra iron (higher dosage or intravenous) to lower the
chance of a blood transfusion postpartum. This also corresponds with the local
protocol and is standard care.
The benefit of this study is to gain more information about the optimal dosage
of iron supplementation in pregnancy, taking into account its effectiveness and
side effects. A lower dose would be preferable, because of the lower incidence
of side effects.
Koeriersterweg 50
Groningen 9727 AD
NL
Koeriersterweg 50
Groningen 9727 AD
NL
Listed location countries
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 <30ug/L) OR mean
corpuscular volume (MCV) < 70fl / hemoglobinopathy is ruled out.
- Adequate mental health
- Good command of the Dutch language
- No participation in other research with medication
- Informed consent
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-005393-26-NL |
| CCMO | NL77578.000.21 |