The efficacy of intermittent versus daily oral iron supplementation in anaemic pregnant women.

Phase 4

Conditions: Anaemia
10002086
10010273

Registration Number: NL-OMON51243

Lead Sponsor: Martini Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 58

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint of the study is the difference in haemoglobin level from<br /><br>baseline to 6 weeks as a continuous variable. A multivariate analysis will be<br /><br>performed with gestational age/trimester at start iron supplementation, the<br /><br>duration of the treatment, use of other supplements, vegetarian diet and the<br /><br>use of proton pump inhibitors or H2 receptor antagonists.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints are haemoglobin level at time of delivery, side<br /><br>effects, therapy compliance, term of delivery, birth weight, parenteral iron<br /><br>ante- or postpartum and blood transfusion postpartum. </p><br>