Iron and Folic acid v.s. Iron solely in the treatment of post partum anaemia, effects on haemoglobin and health status
Phase 3
- Conditions
- kwaliteit van levenanemiairon deficiency1000208610036411
- Registration Number
- NL-OMON32195
- Lead Sponsor
- TweeSteden ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 300
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the amount of increase of haemoglobin (mmol/l) four<br /><br>weeks after delivery in both anaemic sub-groups</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters will be the difference in health status between the<br /><br>anaemic and non-anaemic groups, and between both anaemic sub-groups four weeks<br /><br>after delivery, measured using the RAND-36, CIS and EQ-5D questionnaires. And<br /><br>the observed difference in CHr between the anaemic and non-anaemic groups, and<br /><br>between both anaemic sub-groups four weeks after delivery.</p><br>
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms explain the synergistic effects of iron and folic acid on erythropoiesis in postpartum iron deficiency anemia?
How does the efficacy of iron-folic acid combination compare to standard iron therapy in postpartum anemia for hemoglobin recovery and health-related quality of life?
Which biomarkers, such as serum ferritin or MTHFR polymorphisms, predict response to iron-folic acid versus iron-only treatment in postpartum anemia?
What adverse events are associated with iron-folic acid combination therapy versus iron-only treatment in postpartum anemia, and how are they managed?
Are combination therapies of iron with folic acid more effective than other adjuncts like vitamin B12 or erythropoietin in treating postpartum anemia?