Iron and Folic acid v.s. Iron solely in the treatment of post partum anaemia, effects on haemoglobin and health status - mothers strong as iron

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000599-25-NL

Enrollment

150

Registered

2008-05-29

Start date

2008-05-09

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post partum anemia is generally treated by ferrous fumarate. It is unclear whether the addition of folic acid to ferrous fumarate in the treatment of anaemia could accelerate the increase of haemoglobin. Secondly, health status of post-partum women will be studied in relation tho anaemic and non-anaemic status

Interventions

Product Name: folic acid (vitamin B11) Product Code: P0607 Pharmaceutical Form: Tablet INN or Proposed INN: Folic acid CAS Number: 6848-89-5 Current Sponsor code: 3010 Other descriptive name: folic ac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Women aged > 18 years 2. 0-48 hours after delivery 3. Patients are in a clinical obstetric setting 4. Thorough grasp of the Dutch language 5. Informed consent acceptance Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Pernicious anaemia (Vitamin B12 deficiency) 2. Packed cells infusion in the previous 3 months 3. Alcohol addiction 4. Drug addiction 5. Chronic infection 6. Gastro-intestinal disease or condition (excl. IBS, constipation and diarrhoea) 7. Thalassemia 8. Haemoglobinopathy (Sickle-cell anaemia) 9. Aplastic anaemia 10. Megaloblastic anaemia 11. Haemolytic anaemia and HELLP 12. Malignant disease 13. Kidney failure 14. Liver failure 15. Bone marrow disease

Design outcomes

Primary

Measure	Time frame
Main Objective: What is the difference in haemoglobin increase in women with post partum anaemia (Hb =4,0mmol/l and < 6,5 mmol/l) treated with iron supplementation versus iron plus folic acid supplementation, in a treatment period of 4 weeks? ;Secondary Objective: 1. What is the difference in HS (measured in CIS, RAND-36 and EQ-5D questionnaires). between anaemic (Hb<6,5mmol/l) and non-anaemic (Hb=6,5mmol/l) women, directly post partum and 4 weeks after delivery. And what is the change in HS in women with post partum anaemia treated with iron supplementation versus iron plus folic acid supplementation, in a treatment period of 4 weeks? 2. To establish retrospectively whether the CHr may be used as a better parameter then haemoglobin to determine the need of iron treatment with or without folic acid in women directly post-partum.;Primary end point(s): The main study parameter is the amount of increase of haemoglobin (mmol/l) four weeks after delivery in both anaemic sub-groups. Secondary study parameters will be the difference in health status between the anaemic and non-anaemic groups, and between both anaemic sub-groups four weeks after delivery, measured using the RAND-36, CIS and EQ-5D questionnaires. And the observed difference in CHr between the anaemic and non-anaemic groups, and between both anaemic sub-groups four weeks after delivery.	—

Measure

Time frame

Main Objective: What is the difference in haemoglobin increase in women with post partum anaemia (Hb =4,0mmol/l and < 6,5 mmol/l) treated with iron supplementation versus iron plus folic acid supplementation, in a treatment period of 4 weeks? ;Secondary Objective: 1. What is the difference in HS (measured in CIS, RAND-36 and EQ-5D questionnaires). between anaemic (Hb<6,5mmol/l) and non-anaemic (Hb=6,5mmol/l) women, directly post partum and 4 weeks after delivery. And what is the change in HS in women with post partum anaemia treated with iron supplementation versus iron plus folic acid supplementation, in a treatment period of 4 weeks? 2. To establish retrospectively whether the CHr may be used as a better parameter then haemoglobin to determine the need of iron treatment with or without folic acid in women directly post-partum.;Primary end point(s): The main study parameter is the amount of increase of haemoglobin (mmol/l) four weeks after delivery in both anaemic sub-groups. Secondary study parameters will be the difference in health status between the anaemic and non-anaemic groups, and between both anaemic sub-groups four weeks after delivery, measured using the RAND-36, CIS and EQ-5D questionnaires. And the observed difference in CHr between the anaemic and non-anaemic groups, and between both anaemic sub-groups four weeks after delivery.

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026