Introduction
Woman of reproductive age are particularly at risk owing to blood loss or increased iron demand attributed to menstruation, pregnancy and lactation.1 Iron deficiency anemia (IDA) is associated with adverse cognitive function, physical activity, immune response and pregnancy outcome.2 The properties of iv ferric carboxymaltose (FCM) like neutral PH(5.0-7.0) and physiological osmolarity, which permits it to administer it in larger doses as compared to other iron preparations (single dose up to 1000 mg over 15 mins). Moreover, it does not contain dextran, the chances of serious hypersensitivity reaction is low, its safe and it does not require a test dose.3
Ferric Carboxymaltose though reported in the literature is yet a newer intervention for Indian set up. In a study by Van Wyck et al,4 the results shows increase of Hb by 2g/dl within 7 days and 3 g/dl in 4 weeks in patient receiving ferric carboxymaltose. Patel J et al.5 studied anemic women after administrating ferric carboxymaltose on day 8 and day 15 and reported changes in hemoglobin and serum ferritin levels on day 8 and day 15. The average increase in hemoglobin value was 5.2 g/dl for ferric carboxymaltose.” With this background, the study aims to find the safety and efficacy of intravenous ferric carboxymaltose in the treatment of iron deficiency anemia who has just delivered.
Materials and Methods
The study was a Prospective interventional hospital based therapeutic trial conducted from July 2016 to September 2018 in the department of Obstetrics and Gynecology of Padmashree Dr. D. Y Patil Medical College and Hospital, Pune, Maharashtra. All the postpartum anemic women of more than 18 years of age with HB <10gm/dl during the study period were included in the study. The patients who are suffering from chronic disease, or immunological disorders, allergic to injectable iron compounds, severe anemia who requires blood transfusion, any other serious medical illness are not taken in this study.
Intravenous ferric carboxymaltose (FCM) was administered to the anemic postpartum women. They are available as ampoules of 10 ml containing 500 mg of elemental iron. Total 500 mg/10 ml in 250 ml of 0.9% normal saline infused over 15-20 min. Repeat hemoglobin level was done 15 days after administrating Intravenous ferric carboxymaltose (FCM). Measurement of Hemoglobin was done with Cyanmeth Hemoglobin method. Any side effects or adverse events post injection were also noted.
A voluntary written informed consent was taken from the patient taking part in trial after giving information about all aspects of the study including potential risk. Data of the questionnaire and outcome of blood tests were computerized and analysed in Microsoft excel. Statistics were calculated using Epi Info software. Baseline characteristics, data like hemoglobin level, ferritin level values and adverse reaction or effects were reported in percentages. PAIRED T Test is used to compare data between pre and post Groups. P value < 0.05 was taken as statistically significant.
Result
Table 1
| Age | No. | % |
| <20 | 12 | 20.0 |
| 20-25 | 20 | 33.3 |
| 26-30 | 19 | 31.7 |
| >30 | 9 | 15.0 |
| Parity | ||
| Primigravida | 25 | 41.7 |
| Multigravida | 35 | 58.3 |
| Mode of Delivery | ||
| LSCS | 19 | 31.7 |
| Vaginal | 41 | 68.3 |
| Total | 60 | 100 |
Distribution of patients according to demographic and obstetric profile
Among 60 cases, 20(33.3%) were in 20-25 years age group, 19(31.7%) were in 26-30 years, 35(58.3) cases were multigravida and 41(68.3) cases were delivered vaginaly Table 1 The average age of study participants was 25.6 ± 3.38 years. The commonest risk factor was hypertensive disorder and PPH which does not require blood transfusion Table 2
Table 2
| Risk factor | No. | % |
| PPH not requiring blood transfusion | 8 | 13.3 |
| Hypertensive disorder | 13 | 21.7 |
| Multiple pregnancy | 1 | 1.7 |
| Placenta previa | 3 | 5.0 |
Distribution of patients according to risk factors
Table 3
| Hb Level(gm%) | Base Line | At 2 week | ||
| No. | Percentage | No. | Percentage | |
| 7.1-8 | 17 | 28.3 | 3 | 5.0 |
| 8.1-9 | 33 | 55.0 | 14 | 23.3 |
| 9.1-10 | 10 | 16.7 | 26 | 43.3 |
| >10 | 0 | 0.0 | 17 | 28.3 |
| Total | 60 | 100 | 60 | 100 |
Comparison of patients according to changes in hemoglobin level at 2 weeks
Mean hemoglobin level before intravenous ferric carboxymaltose was 8.42 ± 0.61 gm% while it was 10.03 ± 0.74 gm% after treatment. Before treatment, 17(28.3) women had Hb between 7.1 to 8 gm% which was decreased to 3(5) after treatment with intravenous ferric carboxymaltose.
Table 4
Comparison of patient s according to changes in haematological parameters
There was statistically significant rise in Hb level, Serum ferritin, MCV and MCHC after 2 weeks of treatment.(p < 0.001)
Table 5
Distribution of cases according to adverse effects after intravenous ferric carboxymaltose
Among 60 patients, 5(8.3) patients complained of pain at injection site, 3(5.0) had headache, itching and rash was seen in 2(3.3) cases while nausea and vomiting was experienced by 2(3.3) cases. Abdominal pain, palpitation and anaphylactic reaction with hypotension was not seen in any of the cases. The average hospital stay after intravenous ferric carboxymaltose treatment was 3.12 ± 0.39 days.
Discussion
In the present study, average hemoglobin level before intravenous ferric carboxymaltose was 8.42 ± 0.61 g% while it was 10.03 ± 0.74 g% after treatment. There was mean rise of 1.61 g% in two weeks. The treatment of iron deficiency anemia in patients who has just delivered after administrating any form of iron aims at elevating serum Hb levels by 2.4 – 4.6 g/ dl. There are various studies which suggests increase of Hb level 2-3 g/dl within 4-12 weeks of oral iron therapy. Giannoulis et al. suggested rise in Hb by 4-6 g/dl in 4 weeks in patients receiving iron sucrose.6 Verma U et al. after administrating iron preparations followed up iron deficiency anemia patient on 2, 4, 6 and 12 weeks and suggested that in group A of 50 patients (iron sucrose)average increase of haemoglobin level was 3.95 g/dl and in groups of 50 patients (ferric carboxymaltose) it was 3.32 g/dl at 4 weeks of treatment.7
Van Wyck et al.4 suggested rise of Hb by 2g/dl after treatment with ferric carboxymaltose within 7 days and 3 g/dl in 2 to 4 weeks. Seid et al.8 suggested Hb rise of 3 g/dl or morein ferric carboxymaltose group, faster (median 15 vs. 28 days; P value <0.0001) than ferrous sulfate group. Seid et al. described that the ferritin levels were replenished at day 42 in the patients getting ferric carboxymaltose, but not in oral iron group (238 ng/ml vs 21 ng/ml; p value < 0.0001).8
In our study 12(20) cases reported adverse effects like pain at injection site, itching over the body and mild rash over the back and limbs, headache, nausea and vomiting. In a study done by Patel J et al. adverse effects were reported in 26.67% cases which is comparable to our study.5 All the adverse effects of injection ferric carboxymaltose were mild and typically confined to local reactions.
Conclusion
We conclude from our study that Intravenous ferric carboxymaltose increses Hb levels and improves iron stores better in a shorter period of time. It also elevates serum ferritin levels. No serious adverse effects were noted and it was well tolerated by the patients. Patient compliance was better due to shorter hospital stay and single dose infusion.
