Post Partum Hemorrhage, Anemia
Conditions
Brief summary
The investigator's study is going to compare effectiveness of single dose intravenous iron in combination with oral iron versus oral iron monotherapy in correcting haemoglobin deficit, replenishing iron stores and improving clinical symptoms in women with post-partum anaemia after postpartum hemorrhage without increasing the rate of adverse outcomes.
Interventions
single dose of 1000 mg iron isomaltoside diluted in 100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes. \- infusion set will be covered for blinding
DRUGPlacebo
100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes. \- infusion set will be covered for blinding
DRUGIberet-Folic-500
once a day dose, to start 5 days after the intervention
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* women who underwent spontaneous vaginal delivery with Post partum hemorrhage (PPH) ≥ 500ml OR women who underwent lower segment caesarean section with PPH ≥ 1000 ml * post PPH haemoglobin level ≤ 10.0 g/dl measured within 48hrs after delivery and stabilisation & resuscitation. * ≥ 18 years of age * Proficient in Malaysian language or English language * Willingness to consent for blood taking and attending follow-up at 2 weeks and 6 weeks
Exclusion criteria
* refused consent to participate in trial * history of hemolytic anemia, Thalassemia , and sickle cell anemia * women with signs of sepsis (clinical or laboratory evidence-intrapartum fever \>38.5 degrees with abnormal vital signs, positive blood culture) * clinical or laboratory evidence of hepatic or renal, cardiovascular and hemolytic abnormalities * history of active severe acid peptic disorder, esophagitis or hiatus hernia and malabsorption syndrome. * Severe symptoms of anemia including dyspnoea at rest, angina pectoris, syncope or transient ischemic attacks. * history of severe asthma, eczema or other atopic allergy * known allergy to iron * patients with known immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin concentration (g/dL) | Six weeks after intervention | To evaluate the increase in hemoglobin level |
| Serum iron concentration | Six weeks after intervention | To evaluate the increase in serum iron concentration (µmol/L) |
| Serum ferritin concentration | six weeks after intervention | serum ferritin levels (µg/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General fatigue score | Six weeks after intervention | Using the Multidimensional Fatigue Inventory (MFI) which will be answered by the participants, scores will be taken ranging from lowest 4, till the highest of 20. A higher score will indicate higher levels of fatigue. |
| Number of participants that had adverse effects to intravenous iron | Up to six weeks after intervention | Any adverse effects experienced by the participant arising from the administration of intravenous iron isomaltoside will be documented and managed as per protocol. |
| Blood transfusion requirement | Up to six weeks after intervention | Number of blood transfusions required after intervention |
Countries
Malaysia
Contacts
Primary ContactCarolyn Yim Chue Wai, MBBS
Outcome results
None listed