Status:
UNKNOWN
The Efficacy of Intermittent Versus Daily Oral Iron Supplementation in Anaemic Pregnant Women.
Lead Sponsor:
Martini Hospital Groningen
Collaborating Sponsors:
dr. J.M. Munster, gynaecologist, principal investigator
Conditions:
Iron Deficiency Anemia
Pregnancy Related
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
Background of the study: 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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT05278793
Start Date
January 7 2022
End Date
December 1 2022
Last Update
March 14 2022
Active Locations (1)
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1
Martini Hospital Groningen
Groningen, Netherlands, 9728 NT