Introduction
Anaemia is one of the world’s leading causes of disability and it is one of the most serious public health hazards.1 Anaemia refers to a state wherein the level of haemoglobin in the blood is below the reference range appropriate for that particular age and sex.2
Nutritional anaemia being the most common variant worldwide, can be described as a disease syndrome caused by malnutrition.3 It is found more commonly among women of childbearing age, children and during pregnancy and lactation. Nearly two-thirds of pregnant and one-half of non-pregnant women from the developing countries are seen to be affected by some form of nutritional anaemia.4
The developed countries though less affected, are not completely free of anaemia, and a significant percentage of women of child-bearing age i.e. about 4-12% suffer from anemia.5 Globally, nutritional anaemia affects nearly half of pregnant women, with iron deficiency being recognized as the most common nutritional deficiency among women of childbearing age, in both developed and developing countries.1, 6 It is one of the major contributing factors in maternal morbidity and mortality in third world countries and according to the WHO, it contributes to 20% of the total maternal deaths.7
In India, about 20-40% of maternal deaths are due to anaemia. It is estimated that one in every two women in our country suffers from some form of anaemia.8 The prevalence of anaemia in pregnancy in India as per the National Family Health Survey (NFHS)-3 findings is 55.3%, with a prevalence of 57.4% and 50.9% in rural and urban areas respectively.9, 10, 11
The WHO proposes that “anaemia deficiency should be considered to exist” when the haemoglobin is below the following levels.12, 13
Table 1
Hb levels for anaemia
|
Age/sex |
Hb-g/dl (venous blood) |
MCHC (percent) |
|
Adult males |
13 |
34 |
|
Adult females (non-pregnant) |
12 |
34 |
|
Adult females (pregnant) |
11 |
34 |
|
Children, 6 months to 6 Years |
11 |
34 |
|
Children, 6 to 14 years |
12 |
34 |
The normal MCHC should be 34 irrespective of the age group, any value below being considered abnormal.14, 15
Methodology
A hospital-based, randomized, comparative study was conducted on all antenatal women attending Department of Obstetrics and Gynecology, Shri Sathya Sai Medical College and Hospital were studied over 18 months. Based on the previous study14 the proportion of iron sucrose and ferric carboxymaltose groups are 86% and 14%, using 5% level of significance, 80% power. The total sample size is 100 antenatal women, 50 in each group. The Study was conducted after obtaining ethical clearance from IEC. Patients will be selected according to inclusion and exclusion criteria.
Inclusion criteria
All Antenatal women with iron deficiency anaemia with Hb 6-10gm and peripheral smear suggestive of iron deficiency anaemia.
Exclusion criteria
History of parenteral iron intolerance
Chronic Kidney disease
Haematological disorder
Vitamin B12 and folate deficiency
Deep vein thrombosis, thrombocytosis
Having Thalassemia or sickle cell disease
H/o recent blood transfusion
The study protocol comprised the following activities:
Randomisation
Randomisation was done by computer-generated random numbers assigning patients to both groups-iron sucrose or iron carboxymaltose group.
Intervention
Ferric Carboxymaltose was given as per the total required dose in normal saline infusion as follows:
Iv drip infusion: Dilute in 0 9% sodium chloride / 500 to 1000mg: 250 ml NS - 15 min duration
Not exceeding the maximum dose of 1000 mg /day/ week.
Iron sucrose was given in a dose of 200 mg intravenously in 100ml normalsaline over a period of 15-20 min on alternate days until the required total dose was administered; to the maximum dose of 600 mg/week.
Ganzoni formula:
Deficit = (Target hb{12gm/dl} -Hemoglobin of the patient) × 2.4 × Weight in kg (pre pregnancy) + 1000 (storage).
Follow up
They were followed up after three weeks, for haemoglobin estimation to note the rise in haemogloin values.
Results and Observations
Table 2
Distribution of patients according to the severity of anemia
|
Hb level |
No. of cases |
Percentage |
|
Mild anemia |
7 |
7.0 |
|
Moderate anemia |
93 |
93.0 |
|
Total |
100 |
100.0 |
Table 2 is showing 93% of patients were belongs to moderate anaemia.
Table 3
Correlation between age and severity of anemia
|
Age (years) |
Moderate anemia |
Mild anemia |
No. of cases |
Percentage |
|
<20 |
3 |
- |
3 |
3.0 |
|
20-24 |
52 |
7 |
59 |
59.0 |
|
25-29 |
26 |
1 |
27 |
27.0 |
|
30-34 |
11 |
- |
11 |
11.0 |
|
Total |
92 |
8 |
100 |
100.0 |
Table 3 is showing 59.0% of anemic patients were belongs to the age group of 2-24 years, in that 52.0% of cases were moderate anemia and 7.0% of were mild anemia.
Table 4
Correlation between socioeconomic status and severity of anemia
|
SES |
Moderate anemia |
Mild anemia |
Total no cases |
% |
||
|
Upper middle class |
39 |
4 |
43 |
43.0 |
||
|
Lower middle class |
53 |
4 |
57 |
57.0 |
||
|
Total |
92 |
8 |
100 |
100.0 |
||
|
Chi-Square Test & P-value |
|
□2 = 0.175, |
P = 0.932, |
NS |
|
|
Table 4 is showing 43.0% of anemic patients were belongs to upper middle class and 57.0% of patients were belongs to the lower middle class, so according to our study anemia patients were more common in the lower middle class.
Table 5
Correlation between gravidity and severity of anemia
|
Gravidity |
Moderate anemia |
Mild anemia |
No of cases |
% |
||
|
Primi |
33 |
6 |
39 |
39.0% |
||
|
multi |
59 |
2 |
61 |
61.0% |
||
|
Total |
92 |
8 |
100 |
100.0 |
||
|
Chi-Square Test & P-value |
|
□2 = 4.73, |
P = 0.039, |
S |
|
|
Table 5 is showing that anemia was more common in multigravida patients, that were 61.0% and 39.0% patients were primi gravida.
Table 6
Correlation between gestational age and severity of anemia
|
Gestational age in weeks |
Moderate anemia |
Mild anemia |
No. of cases |
% |
|
15-21 |
20 |
- |
20 |
20.0 |
|
22-28 |
56 |
7 |
63 |
63.0 |
|
29-35 |
16 |
1 |
17 |
17.0 |
|
Total |
92 |
8 |
100 |
100.0 |
Table 6 shows that 63.0% of anemic patients were in the gestational age group of 22-28 weeks because of hemodiluation.
Table 7
Distribution of cases according to Hb level
Study observed that, majority of the cases 93 (93.0%) were belongs to the moderate (7-9%) Hb% level and 7 (7.0%) were belongs to the mild Hb% level. There was no statistical significant difference of Hb% level between the groups FCM and Iron sucrose (P>0.05).
Table 8
Distribution of cases according to adverse effect
Study reveals that, there was no statistical significant difference of adverse effects between the groups of FCM and Iron Sucrose (P>0.05).
Table 9
Comparison of mean Hb% level before treatment and after 3 weeks treatment and also comparison between the groups
Study reveals that, there was statistically very highly significant difference of mean Hb% level before and after the treatment in FCM and Iron sucrose groups respectively (P<0.001).
After the treatment the mean HB% level has significantly increased in both the groups, therefore the treatment was effective in both the groups (P<0.001). But FCM group showed more increase the Hb% level as compare to Iron sucrose group.
Discussion
Nutritional anemia in pregnancy is a public health problem especially in developing countries and the commonest is iron deficiency anemia. Anemia in pregnancy is significantly associated with both fetal and maternal morbidity. Rapid improvement of Hb and iron stores in pregnancy will improve the general health status of the patient and decrease complications.
The patients in our study belonged to the age group of 18-35 years. The Majority of them were of the age group of 19-24 years in both study groups. The mean age was found to be slightly lesser in our study (24.8±4.4 and 24.5±3.1 years) when compared to other studies such as Christoph P et al.12 (29 and 29.9 years) and Patel J et al.,13 (29,1±2.4 and 28.4±3.7 yrs). This might suggest early marriage and pregnancy in patients in our study. Other maternal data such as Obstetric Index and gestational age though showed slight variations in either group were not significant as in other studies. Mean body weight (48.6 kg and 49.7 kg) was also significantly lower in our study as compared to prior studies (73.1 and 69.3 kg) by Christoph et al.,12 which suggests that patients in our study were poorly nourished.
Baseline Hb in our study was 7.8±1.2 g/dl in group 1 and 8.7±0.9g/dl in group 2, thus group 2 had anaemia to a slightly lesser degree. However, this did not account for bias as the patients received iron infusion depending on the dose calculated based on their respective Hb levels. The baseline Hb in other studies were slightly higher 9.7±0.9 and 9.5±4.9 g/dl in Christoph P et al., and 8.7±3.1 and 8.9±2.3 g/dl in Patel J et al.,.12, 13 This again suggests that our study population had slightly higher grades of anaemia and required more vigorous management. Serum ferritin levels were however comparable to other studies (12.8±29.1 mcg/L Christoph P et al.,) in group 1,11.2±7.9 mcg/L. Group 2 however owing to a lesser degree of anaemia had raised baseline serum ferritin levels (20.1±13.6 mcg/L versus 7±5.65 mcg/L in Christoph P et al.,).12 Other iron parameters such as serum iron and TIBC were also significantly better in group 2(57.4 mcg/dl and 357.1 mcg/dl respectively).
The mean iron required in group 1 of the present study was significantly higher than group 2 (978.1 versus 882.8 mg). Likewise, the total iron infused was also more in group 1(966.7 versus 743.3mg).
Christoph P et al.12 also showed similar differences in iron infused (933 versus 402 mg). Thus, our study population had iron deficiency and thus anaemia of higher severity.
In regards to the type of anaemia histologically, the majority of our patients had microcytic, hypochromic blood picture in both groups (65%) suggesting that majority had severe grades of iron deficiency.
The present comparative study investigated the efficacy and safety of FCM and iron sucrose in IDA of pregnancy. It was seen that both IV iron preparations were effective in treating IDA in pregnancy. FCM therapy efficiently increased Hb, at the end of 3 weeks following treatment. The Hb rise with FCM was 1.5±0.1g/dl at 3 weeks.
These results are in line with several other studies. A study by Christoph P et al.,12 on 206 pregnant women with IDA showed a Hb increase of 1.5±1.1g/dl at the end of 3 weeks. A similar study by Pels A et al., in the Netherlands showed Hb increase of 2.3 g% in 3 weeks. Patel J et al.,13 had Hb increase of 5.2 g/dl,15 days post treatment whereas the ferritin levels improved by 9.2 mcg/L.
Hb and ferritin values also improved after treatment with iron sucrose. Our study at the end of 3 weeks showed Hb increment of 0.7 -1.4 mg/dl. Christoph P et al.12 showed similar rise in Hb of 1.1g/dl in 4 weeks, whereas Patel J et al.,13 an Indian study, showed a rise of 3.7g/dl in 15 days. The ferritin increase in this previous Indian study was 9.2 mcg/L. Thus, in terms of efficiency, both FCM and iron sucrose showed improved results in our study as compared to several previous studies.
However, our study aimed to also compare the efficacy of FCM therapy to iron sucrose. At the end of 3 weeks, FCM showed significantly increased Hb and ferritin as compared to iron sucrose, post treatment.
Thus, our study shows, that FCM is well tolerated in pregnant women and has fewer number of side effects as compared to iron sucrose even when given as a large dose.
Conclusion
In conclusion, FCM not only offers a rapid correction of Hb levels but also provides replenishment of iron stores in the body, without major adverse effects. Thus, when used in pregnant women in their second or third trimesters the hazard of anaemia is not only tackled in pregnancy but might also be prevented in the post-partum period. At the end, we have a healthy mother with a healthy baby, which is a birth right of every woman. At the national level, this will tremendously reduce the burden of maternal morbidity and mortality and improve the quality of life. Hence, all the health care providers, hospital administration and the government should take measures to make FCM easily available and affordable to the women who are in actual need of it and make use of this boon to eradicate.
