None listed
Conditions
Brief summary
Anaemia is a condition in which the number of red blood cells or the amount of the oxygen-carrying protein, haemoglobin, within them is lower than normal. Anaemia in pregnancy remains a critical global health problem and carries significant risks for both mother and child. The World Health Organisation recommends that anaemic pregnant women increase their daily iron intake, yet few pregnant women receive or take the full recommended course of oral iron in low-middle income countries. With this in mind, new iron products, delivered via the arm vein (intravenous), provide a chance to give high doses of iron in a single rapid infusion. Ferric Carboxymaltose is a common iron formulation given intravenously in high income settings. One noted side effect of Ferric Carboxymaltose infusion is a short-term low phosphate in the blood (hypophosphatemia). Although the use of Ferric Carboxymaltose as a single treatment of anaemia in pregnancy has not been associated with significant clinical problems, there is limited information examining phosphate levels in pregnant women receiving this treatment. The EDIVA-Phase study aims to evaluate the level of phosphate in the blood following intravenous iron treatment of anaemic pregnant women in their second trimester of pregnancy in Bangladesh.
Interventions
Participants will be assigned to receive the following once during the second trimester: intravenous ferric carboxymaltose (1000 mg for body weight >50 kg, or 20 mg/kg for body weight <50 kg) in 250mL normal saline, over 15 minutes. The intervention is administered by a nurse at a health facility and it is recorded in the trial database as a condition of being enrolled in the trial. Therefore, the administration of the intervention will be directly observed.
Sponsors
icddr,b
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants meeting the following criteria will be included in the trial: 1. Confirmed singleton pregnancy in the second trimester (13-25 completed weeks of gestation), dated by ultrasound. 2. Moderate to severe anaemia (capillary haemoglobin (Hb) <10g/dl). 3. Currently afebrile. 4. Expected to deliver the baby inside or within 30 minutes of road transport of the study catchment area. 5. Have drinking water iron <2mg/L. 5. Written informed consent (if <18 years of age, consent will be collected from her guardian, while she will sign an assent form).
Exclusion criteria
1. Previous enrolment in EDIVA trial (PR-20125). 2. Actively participating in another intervention trial. 3. Known hypersensitivity to the study drug. 4. Clinical symptoms of current bacterial/ viral infection (fever, focal symptoms of internal infection i.e. LRTI/ diarrhoea). 5. Any condition requiring hospitalisation in the next seven days or serious concomitant illness. 6. Known to have a diagnosis of thalassemia, sickle cell or sickle-haemoglobin C anaemia or other inherited red cell condition 7. Women with severe anaemia requiring an emergency blood transfusion (Hb <5g/dL), or with haemodynamic or acute clinical compromise as judged by a study physician. 8. Known diagnosis of preeclampsia 9. Known diagnosis of X-linked hypophosphatemia 10. Women who have already received a dose of intravenous iron during the current pregnancy.
Outcome results
None listed