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What is the difference in haemoglobin increase in women with post partum anaemia treated with iron supplementation versus iron plus folic acid supplementation, in a treatment period of 4 weeks.


- candidate number7785
- NTR NumberNTR2232
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-feb-2010
- Secondary IDsNL21797.028.08 METC/CCMO
- Public TitleWhat is the difference in haemoglobin increase in women with post partum anaemia treated with iron supplementation versus iron plus folic acid supplementation, in a treatment period of 4 weeks.
- Scientific TitleIron and Folic acid v.s. Iron solely in the treatment of post partum anaemia; effects on haemoglobin and health status.
- ACRONYMIjzersterke moeders
- hypothesisOur first hypothesis is that in severe post partum anaemia (Hb < 6,5 mmol/l) treated with ferrous fumarate plus folic acid has an additional increased rise in haemoglobin compared to the standard treatment of ferrous fumarate alone, in the period of 4 weeks after delivery. In concurrence with previous studies, it is expected that patients with a more severe anaemia will have a more rapid increase in haemoglobin compared to patients with a less severe anaemia.

Our second hypothesis is that women with a severe post partum anaemia (Hb < 6,5 mmol/l) are associated with an decrease in health status compared to post partum women without an anaemia (Hb >6,5 mmol/l), and secondly that ferrous fumarate plus folic acid treatment in anaemic women will give an additional increase in health status compared to the standard treatment of ferrous fumarate treatment solely, in the period of 4 weeks after delivery.

An additional secondary objective in this study is, to establish retrospectively whether the CHr (reticulocyte haemogobin content) 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.
- Healt Condition(s) or Problem(s) studiedAnemia, Quality of life, Post partum, Ferrofumarate, Haemoglobin
- Inclusion criteria1. 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.
- Exclusion criteria1. Pernicious anaemia (Vitamin B12 deficiency: serum vitamin B12 < 100 pmol/l and/or holotranscobalamin < 20 pmol/l);
2. Packed cells infusion in the last 3 months;
3. Haemoglobin < 4,0 mmol/l;
4. Alcohol addiction;
5. Drug addiction;
6. Chronic infection;
7. Gastro-intestinal disease or condition (excl. IBS, constipation and diarrhoea);
8. Thalassemia, hemoglobinopathy (Sickle-cell anaemia), aplastic anaemia, megaloblastic anemie, haemolytic anaemia and HELLP;
9. Malignant disease, kidney failure, liver failure, bone marrow disease;
10. Methotrexate (interaction with folic acid);
11. Contra-indication folic acid (hypersensitivity);
12. Contra-indication ferrous fumarate (hypersensitivity).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2008
- planned closingdate1-okt-2010
- Target number of participants300
- InterventionsTwo main study groups will be constructed, each 150 patients, one non-anaemic group (haemoglobin >=6,5 mmol/l) and one anaemic group (haemoglobin <6,5 mmol/l). Women in the anaemic study group will be randomised into two different treatment strategies, one group (n=75) receives three times daily a 200 mg tablet of ferrous fumarate and the other group (n=75) receives three times daily a 200 mg tablet of ferrous fumarate added with twice daily 0,5 mg of folic acid.
- Primary outcomeThe main study parameter is the amount of increase of haemoglobin (mmol/l) four weeks after delivery in both anaemic sub-groups.
- Secondary outcomeSecondary 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.
- Timepoints0-48 hours after delivery and 4 weeks after delivery.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES D. Woude, van der
- CONTACT for SCIENTIFIC QUERIES D. Woude, van der
- Sponsor/Initiator TweeSteden hospital, location Tilburg
- Funding
(Source(s) of Monetary or Material Support)
Tilburg University
- PublicationsN/A
- Brief summaryRationale: Additional folic acid to ferrous fumarate in the treatment of anaemia could accelerata the increase of haemoglobin. Whether or not this has an effect on the health status of the patients is not known.

Objective: Our main objective is to determine whether additional folic acid to ferrous fumarate contributes to the increase of haemoglobin and the improvement of health status in post partum anaemia. Our second objective is to asses what the difference in health status is between anaemic and non-anaemic post partum women.

Study design: Randomized controlled trial, and prospective cohort.

Study population: Healthy women who delivered at the TweeSteden hospital with either a clinical indication for anaemia, or more than 500ml of blood loss during labour.

Intervention: Two main study groups will be constructed, each 150 patients, one non-anaemic group (haemoglobin >=6,5 mmol/l) and one anaemic group (haemoglobin <6,5 mmol/l). Women in the anaemic study group will be randomised into two different treatment strategies, one group (n=75) receives three times daily a 200 mg tablet of ferrous fumarate and the other group (n=75) receives three times daily a 200 mg tablet of ferrous fumarate added with twice daily 0,5 mg of folic acid.

Main study parameters/endpoints: 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.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The treatment of postpartum anaemia with ferrous fumarate is common and the addition of folic acid is nowadays dependent on the clinician. So far, there are no risks for the patients who participate in the study. Women with vitamin B12 deficiency could be at risk but are excluded from the study.
- Main changes (audit trail)
- RECORD23-feb-2010 - 14-feb-2012


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