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…
ID
Source
Brief title
Condition
- Other condition
- Anaemias nonhaemolytic and marrow depression
- Postpartum and puerperal disorders
Synonym
Health condition
kwaliteit van leven
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the amount of increase of haemoglobin (mmol/l) four
weeks after delivery in both anaemic sub-groups
Secondary outcome
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.
Background summary
additional folic acid to ferrous fumarate in the treatment of anaemia could
accelerate the increase of haemoglobin. Whether or not this has an effect on
the health status of the patients is not known.
Study 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.
Intervention
two main study groups will be constructed, each 150 patient, one non-anaemic
group (haemoglobin *6,5mmol/l) and one anaemic group (haemoglobin <6,5mmol/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.
Study burden and risks
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.
Postbus 90107
5000 LA Tilburg
Nederland
Postbus 90107
5000 LA Tilburg
Nederland
Listed location countries
Age
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
Exclusion criteria
1. Pernicious anaemia (Vitamin B12 deficiency)
2. Packed cells infusion in the previous 3 months
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
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-000599-25-NL |
| CCMO | NL21797.028.08 |
| OMON | NL-OMON25164 |