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IOSR Journal of Dental and Medical Sciences (IOSR-JDMS)
e-ISSN: 2279-0853, p-ISSN: 2279-0861.Volume 14, Issue 12 Ver. II (Dec. 2015), PP 95-97
www.iosrjournals.org
DOI: 10.9790/0853-141229597 www.iosrjournals.org 95 | Page
Comparative Study of Parentral Iron Sucrose Vs Oral Ferrous
Ascorbate for Prophylactic Iron Therapy in Pregnancy
(Dr. Sajana Gogineni1
, Dr. Prashanthi Vemulapalli 2
)
1
(PROFESSOR & HOD, Department of OBG, Dr. PSIMS & RF, Chinoutpalli, Gannavaram, Krishna Dt, AP,
India)
2
(ASSISTANT PROFESSOR, Department of OBG, Dr. PSIMS & RF, Chinoutpalli, Gannavaram, Krishna Dt,
AP, India)
Abstract: Nutritional requirements increase many fold in pregnancy. Of the nutrients iron supplementation
requires special attention to meet the growing demands of pregnancy. Oral iron therapy has poor compliance
due to gastric side effects. Iron sucrose has been proved safe and efficacious in pregnancy. The aim of our study
is to compare iron sucrose with ferrous ascorbate for prophylactic iron therapy in pregnancy in terms of Hb%
rise, side effects, compliance and cost of therapy.
Methodology: 100 pregnant women fulfilling the inclusion criteria between 20-24 weeks were selected &
divided into 2 groups 50 each. Group A was allocated to use 3 doses of Iron sucrose, each dose 200 mg in 100
ml normal saline as infusion over 15 – 20 min at 20 – 27, 28 – 32, & 33 – 36 weeks respectively & Group B was
allocated to use oral ferrous ascorbate 100 mg tablet once daily at bed time. All pregnant mothers were
followed till 40 weeks.
Results: Commonest age distribution was 21 – 25 years & multigravidas were more common in both groups.
Mean Hb % rise in Group A was 0.3±0.18 & Group B was 0.12 ± 0.88 with ( P 0.13) which was statistically not
significant. 4% of cases in Group A had rash and pain at injection site where as 66% had gastric side effects in
Group B. 4% lost compliance in group A as compared to 40% in group B.Cost of therapy was comparable in
both Groups.
Conclusion: Iron sucrose is safe to use in pregnancy.Though oral iron is easy to administer & non invasive it
is associated with gastric side effects resulting in poor compliance, therefore parentral iron sucrose is a safe
alternative for prophylactic iron therapy in pregnancy.
Keywords: Iron sucrose, ferrous ascorbate, prophylactic iron therapy, iron therapy in pregnancy.
I. Introduction
Pregnancy is a demand state in terms of nutrition, rest and medical care. Of the nutrients required iron
intake needs a special attention, the reason being the demands increase drastically in pregnancy.
Total iron requirement in pregnancy is around 800 – 1000 mg1
of which 200 mg is saved by pregnancy
amenorrhoea and partially to an extent by diet. Unlike the westeners most Indian women enter pregnancy with
poor iron stores2
. Therefore there is a need to supplement iron in pregnancy to meet the growing needs. It is a
well known fact that there is no ideal iron preparation which is totally effective and devoid of side effects3
. The
gastric side effects of oral iron preparations add up to existing gastritis of pregnancy resulting in poor
compliance. Safety issues related to parental iron preparations in terms of anaphylaxis and teratogenicity has
limited their use. Therefore there is a need for iron preparation which is tolerated well and has minimal side
effects, has good bioavailability & compliance. Iron sucrose has proved beyond doubt about its safety and
efficacy in pregnancy4
. Ferrous ascorbate has best bioavailability (40%)(5-8)
among oral iron preparations and
has least gastric side effects hence used in our study.
AIM:
To compare intravenous iron sucrose and oral ferrous ascorbate in terms of: Clinical efficacy (Hb% rise), side
effects, compliance, cost of therapy and
To analyse if iron sucrose can be substituted for oral iron preparations for iron prophylaxis in pregnancy.
II. Methodology
It was a prospective study. Institutional ethical clearance was taken. Study included 100 pregnant
women between 20 – 24 wks of gestation who gave consent for study and fulfilled the inclusion criteria of Hb%
> 10.5 gm% and ruled out exclusion criteria of multiple pregnancy, medical & pregnancy complications.
Pregnant women were divided into two groups by random colour coin method. Tab albendazole 400 mg was
given at beginning of study to all pregnant mothers. Group A consisted of 50 women who were allocated to use
3 doses of iron sucrose 200 mg in 100 ml normal saline as infusion over 15 – 20 min at 20 – 27, 28 – 32, 33 – 36
Comparative Study of Parentral Iron Sucrose Vs Oral Ferrous Ascorbate for Prophylactic Iron...
DOI: 10.9790/0853-141229597 www.iosrjournals.org 96 | Page
weeks respectively. Group B was allocated to use oral ferrous ascorbate every day 100 mg at bed time one hour
prior to food. Hb% was estimated at 28, 32, 36 & 40 weeks. Women who developed pregnancy complications
in the course of study were excluded. Pregnant women were given questionnaire related to side effects of
respective drugs at 40 wks & analysed. Outcome in terms of Hb% rise, side effects, compliance & cost of
treatment were analysed.
III. Results
Age distribution in both Groups were comparable commonest being 21 – 25 yrs. Gravidity was also
comparable commonest being multigravidas.Mean Hb% difference in Group A was 0.3 with SD 0.18 as
compared to 0.12 with SD of 0.88 in Group B. Mann Whitney U test was used to compare the Hb% rise in both
groups. P value obtained was 0.13 which showed that there was no statistically significant difference in both
groups in terms of Hb% rise. 6% in Group A developed anaemia as compared to 18% in Group B, both the
Groups it was mild anaemia. In Group A, 2% of cases had minor rash following iron sucrose infusion, 6% had
pain during infusion. 92% of cases did not experience any significant side effects. In Group B 12% of patients
experienced constipation, 24% gastritis, 30% nausea & vomiting, only 34% were symptom free. 4% lost
compliance in Group A as compared to 40% loss of compliance in Group B. Cost of therapy in Group A was
1600/- for three doses as compared to 1500/- for Group B which was comparable.
Side effects
group A
fever
rash/itching
no side
effects
group B
constipation
gastritis
nausea/vomi
ting
no side
effects
2%
6%
92%
12%
24%
30%
34%
IV. Discussion
Iron supplementation is mandatory in pregnancy In India unlike westerners who have better iron stores
and supplementation is optional. Though oral iron preparations are easy to administer & cost effective
compliance is a concern due to gastric side effects. There are several studies comparing iron sucrose Vs oral iron
for treatment of anaemia in pregnancy9-13
but very few studies are available for prophylactic iron therapy.
Bencovia G14
conducted similar study on 260 pregnant women and results were comparable to our
study in terms of efficacy. Mean age of recruitment in our study was comparable with other studies(9-14)
. There
was no significant difference in parity & comparable with other studies10
. There was no statistically significant
increase in Hb% in both the Groups (P 0.13), the outcome was similar in other studies14
. Side effects were seen
in 40% of oral iron Group in our study in contrast to 32 – 50% in other studies14
(chisquare test was used).
Compliance was better in iron sucrose Group and results were comparable with other studies(9-15)
. Ferritin levels
were not measured in our study which would be a better parameter to assess iron stores.
V. Conclusion
Iron supplementation is essential to meet the growing needs of pregnancy as most Indian mothers enter
pregnancy with poor iron stores. Oral Iron preparation though safe are associated with gastric side effects
resulting in poor compliance. More than 50% of pregnant women stop iron intake due to related side effects
resulting in anaemia & poor feto maternal outcomes. Several studies have proved the safety & efficacy of iron
sucrose in pregnancy. It is tolerated well & has no major side effect, therefore can be used as a substitute for oral
preparations. In our study there were no major side effects with iron sucrose & had better compliance so can be
safely used in pregnancy. Yet larger trials are required to conclude that parentral preparation can be substituted
for oral preparations.
0
5
10
15
20
25
Group
A
Group
B
4%
40%
Lost
compliance
Comparative Study of Parentral Iron Sucrose Vs Oral Ferrous Ascorbate for Prophylactic Iron...
DOI: 10.9790/0853-141229597 www.iosrjournals.org 97 | Page
Acknowledgements
Department of OBG
Dr. PSIMS & RF,CHINNAOUTAPALLI, GANNAVARAM, AP
References
[1]. Arias F, Daftary SN, Bhide AG. Haematological Disorders in Pregnancy. In: Arias F, Daftary SN, Bhide AG (eds). Practical Guide
to High-risk Pregnancy and Delivery Third edition. Haryana, Elsevier India Pvt Ltd; 2010:465-488.
[2]. Raymond J P, Christopher E M et al, Amj clin nutrition July 200 Vol. 72, No. 1, 5-14
[3]. Khalafallah AA, Dennis AE, Ogden K, Robertson I, Charlton RH, Bellette JM, et al.Three-year follow-up of a randomised clinical
trial of intravenous versus oral iron for anaemia in pregnancy. BMJ Open. 2012; 2(5). pii: e000998. doi: 10.1136/bmjopen-2012-
000998. Print 2012.
[4]. Goodman and Gilman’s “The Pharmacological basis of therapeutics”, McGraw – Hill, 10h Edition, 1947.
[5]. Plug Cm, Dekkar D, Bult A, “ Complex stability of Ferrous ascorbate in aquesous solution and its significance for iron absorption”,
Pharm weekbl Sci., 1984 Dec 14;6(6): 245 – 8.
[6]. Agarwal MB, Rathi SA. An open label, randomized, comparative clinical study to assess the efficacy and tolerability of ferrous
ascorbate versus carbonyl iron in the treatment of iron deficiency anaemia. Int J Gynecol and Obstet – India, July – August, 2005;8
(4): 23-30.
[7]. HERS Study Group, India. The HERS Trial Report: A prospective, open – label study on efficacy and tolerability of Ferrous
Ascorbate (Orofer – XT Tablet). Inj J Gynecol and Obstet – India, July- August,2005;8(4): 23 – 30.
[8]. Kuropteva ZV, Kudryavtsev ME. Ferrous-ascorbate complexes as carriers of nitric oxide. Gen Physical Biophys. 1997 Mar;16
(1):91 – 6.
[9]. al-Momen AK, al-Meshari A, al-Nuaim L, Saddique A, Abotalib Z, Khashogji T, et al. Intravenous iron sucrose complex in the
treatment of iron deficiency anemia during pregnancy. Eur J Obstet Gynecol Reprod Biol. 1996 Nov; 69(2): 121-4.
[10]. Ragip A, Unlubilgin E, Kandemir O, Yalvac S, Cakir L, Haberal A. Intravenous versus oral iron treatment of anaemia in pregnancy:
a randomized trial. Obstet Gynaecol. 2005; 106:1335-1340.
[11]. Bayoumeu F, Subiran C, Baka NE, Legagneur H, Monnier P, Laxenaire MC. Iron therapy in iron deficiency anaemia in pregnancy:
Intravenous versus oral route. Am J Obstet Gynecol. 2002; 88:3-10.
[12]. Froessler B, Cocchiaro C, Saadat-Gilani K, Hodyl N, Dekker G.Intravenous iron sucrose versus oral iron ferrous sulfate for
antenatal and post-partum iron deficiency anaemia: a randomised trial. J Matern Fetal Neonatal Med.2012.
[13]. Kochhar PK, Kaundal A, Ghosh P. Intravenous iron sucrose versus oral iron in treatment of iron deficiency anemia in pregnancy: A
randomized clinical trial. J Obstet Gynaecol Res. 2012 Aug 26. doi: 10.1111/j. 1447-0756.2012.01982.x.
[14]. Bencaiova G, Von Mandach U, Zimmermann R Iron prophylaxis in Pregnancy in Preganncy: intravenous route vs oral route. Eur,
obstet Gynaecol reprod boil 2009:vol 144:135-9
[15]. Abhilashini G.D. Hasitha S, Reddi R. Intravenous Iron sucrose and oral iron for the treatment of iron deficiency anaemia in
pregnancy. Journal of clinical and diagnostic research 2014;Vol May 8:5
[16]. Kripalani A Reeta M et al. Iron Sucrose therapy for anaemia Indian J med Res July 2013;138:78-82

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Comparative Study of Parentral Iron Sucrose Vs Oral Ferrous Ascorbate for Prophylactic Iron Therapy in Pregnancy

  • 1. IOSR Journal of Dental and Medical Sciences (IOSR-JDMS) e-ISSN: 2279-0853, p-ISSN: 2279-0861.Volume 14, Issue 12 Ver. II (Dec. 2015), PP 95-97 www.iosrjournals.org DOI: 10.9790/0853-141229597 www.iosrjournals.org 95 | Page Comparative Study of Parentral Iron Sucrose Vs Oral Ferrous Ascorbate for Prophylactic Iron Therapy in Pregnancy (Dr. Sajana Gogineni1 , Dr. Prashanthi Vemulapalli 2 ) 1 (PROFESSOR & HOD, Department of OBG, Dr. PSIMS & RF, Chinoutpalli, Gannavaram, Krishna Dt, AP, India) 2 (ASSISTANT PROFESSOR, Department of OBG, Dr. PSIMS & RF, Chinoutpalli, Gannavaram, Krishna Dt, AP, India) Abstract: Nutritional requirements increase many fold in pregnancy. Of the nutrients iron supplementation requires special attention to meet the growing demands of pregnancy. Oral iron therapy has poor compliance due to gastric side effects. Iron sucrose has been proved safe and efficacious in pregnancy. The aim of our study is to compare iron sucrose with ferrous ascorbate for prophylactic iron therapy in pregnancy in terms of Hb% rise, side effects, compliance and cost of therapy. Methodology: 100 pregnant women fulfilling the inclusion criteria between 20-24 weeks were selected & divided into 2 groups 50 each. Group A was allocated to use 3 doses of Iron sucrose, each dose 200 mg in 100 ml normal saline as infusion over 15 – 20 min at 20 – 27, 28 – 32, & 33 – 36 weeks respectively & Group B was allocated to use oral ferrous ascorbate 100 mg tablet once daily at bed time. All pregnant mothers were followed till 40 weeks. Results: Commonest age distribution was 21 – 25 years & multigravidas were more common in both groups. Mean Hb % rise in Group A was 0.3±0.18 & Group B was 0.12 ± 0.88 with ( P 0.13) which was statistically not significant. 4% of cases in Group A had rash and pain at injection site where as 66% had gastric side effects in Group B. 4% lost compliance in group A as compared to 40% in group B.Cost of therapy was comparable in both Groups. Conclusion: Iron sucrose is safe to use in pregnancy.Though oral iron is easy to administer & non invasive it is associated with gastric side effects resulting in poor compliance, therefore parentral iron sucrose is a safe alternative for prophylactic iron therapy in pregnancy. Keywords: Iron sucrose, ferrous ascorbate, prophylactic iron therapy, iron therapy in pregnancy. I. Introduction Pregnancy is a demand state in terms of nutrition, rest and medical care. Of the nutrients required iron intake needs a special attention, the reason being the demands increase drastically in pregnancy. Total iron requirement in pregnancy is around 800 – 1000 mg1 of which 200 mg is saved by pregnancy amenorrhoea and partially to an extent by diet. Unlike the westeners most Indian women enter pregnancy with poor iron stores2 . Therefore there is a need to supplement iron in pregnancy to meet the growing needs. It is a well known fact that there is no ideal iron preparation which is totally effective and devoid of side effects3 . The gastric side effects of oral iron preparations add up to existing gastritis of pregnancy resulting in poor compliance. Safety issues related to parental iron preparations in terms of anaphylaxis and teratogenicity has limited their use. Therefore there is a need for iron preparation which is tolerated well and has minimal side effects, has good bioavailability & compliance. Iron sucrose has proved beyond doubt about its safety and efficacy in pregnancy4 . Ferrous ascorbate has best bioavailability (40%)(5-8) among oral iron preparations and has least gastric side effects hence used in our study. AIM: To compare intravenous iron sucrose and oral ferrous ascorbate in terms of: Clinical efficacy (Hb% rise), side effects, compliance, cost of therapy and To analyse if iron sucrose can be substituted for oral iron preparations for iron prophylaxis in pregnancy. II. Methodology It was a prospective study. Institutional ethical clearance was taken. Study included 100 pregnant women between 20 – 24 wks of gestation who gave consent for study and fulfilled the inclusion criteria of Hb% > 10.5 gm% and ruled out exclusion criteria of multiple pregnancy, medical & pregnancy complications. Pregnant women were divided into two groups by random colour coin method. Tab albendazole 400 mg was given at beginning of study to all pregnant mothers. Group A consisted of 50 women who were allocated to use 3 doses of iron sucrose 200 mg in 100 ml normal saline as infusion over 15 – 20 min at 20 – 27, 28 – 32, 33 – 36
  • 2. Comparative Study of Parentral Iron Sucrose Vs Oral Ferrous Ascorbate for Prophylactic Iron... DOI: 10.9790/0853-141229597 www.iosrjournals.org 96 | Page weeks respectively. Group B was allocated to use oral ferrous ascorbate every day 100 mg at bed time one hour prior to food. Hb% was estimated at 28, 32, 36 & 40 weeks. Women who developed pregnancy complications in the course of study were excluded. Pregnant women were given questionnaire related to side effects of respective drugs at 40 wks & analysed. Outcome in terms of Hb% rise, side effects, compliance & cost of treatment were analysed. III. Results Age distribution in both Groups were comparable commonest being 21 – 25 yrs. Gravidity was also comparable commonest being multigravidas.Mean Hb% difference in Group A was 0.3 with SD 0.18 as compared to 0.12 with SD of 0.88 in Group B. Mann Whitney U test was used to compare the Hb% rise in both groups. P value obtained was 0.13 which showed that there was no statistically significant difference in both groups in terms of Hb% rise. 6% in Group A developed anaemia as compared to 18% in Group B, both the Groups it was mild anaemia. In Group A, 2% of cases had minor rash following iron sucrose infusion, 6% had pain during infusion. 92% of cases did not experience any significant side effects. In Group B 12% of patients experienced constipation, 24% gastritis, 30% nausea & vomiting, only 34% were symptom free. 4% lost compliance in Group A as compared to 40% loss of compliance in Group B. Cost of therapy in Group A was 1600/- for three doses as compared to 1500/- for Group B which was comparable. Side effects group A fever rash/itching no side effects group B constipation gastritis nausea/vomi ting no side effects 2% 6% 92% 12% 24% 30% 34% IV. Discussion Iron supplementation is mandatory in pregnancy In India unlike westerners who have better iron stores and supplementation is optional. Though oral iron preparations are easy to administer & cost effective compliance is a concern due to gastric side effects. There are several studies comparing iron sucrose Vs oral iron for treatment of anaemia in pregnancy9-13 but very few studies are available for prophylactic iron therapy. Bencovia G14 conducted similar study on 260 pregnant women and results were comparable to our study in terms of efficacy. Mean age of recruitment in our study was comparable with other studies(9-14) . There was no significant difference in parity & comparable with other studies10 . There was no statistically significant increase in Hb% in both the Groups (P 0.13), the outcome was similar in other studies14 . Side effects were seen in 40% of oral iron Group in our study in contrast to 32 – 50% in other studies14 (chisquare test was used). Compliance was better in iron sucrose Group and results were comparable with other studies(9-15) . Ferritin levels were not measured in our study which would be a better parameter to assess iron stores. V. Conclusion Iron supplementation is essential to meet the growing needs of pregnancy as most Indian mothers enter pregnancy with poor iron stores. Oral Iron preparation though safe are associated with gastric side effects resulting in poor compliance. More than 50% of pregnant women stop iron intake due to related side effects resulting in anaemia & poor feto maternal outcomes. Several studies have proved the safety & efficacy of iron sucrose in pregnancy. It is tolerated well & has no major side effect, therefore can be used as a substitute for oral preparations. In our study there were no major side effects with iron sucrose & had better compliance so can be safely used in pregnancy. Yet larger trials are required to conclude that parentral preparation can be substituted for oral preparations. 0 5 10 15 20 25 Group A Group B 4% 40% Lost compliance
  • 3. Comparative Study of Parentral Iron Sucrose Vs Oral Ferrous Ascorbate for Prophylactic Iron... DOI: 10.9790/0853-141229597 www.iosrjournals.org 97 | Page Acknowledgements Department of OBG Dr. PSIMS & RF,CHINNAOUTAPALLI, GANNAVARAM, AP References [1]. Arias F, Daftary SN, Bhide AG. Haematological Disorders in Pregnancy. In: Arias F, Daftary SN, Bhide AG (eds). Practical Guide to High-risk Pregnancy and Delivery Third edition. Haryana, Elsevier India Pvt Ltd; 2010:465-488. [2]. Raymond J P, Christopher E M et al, Amj clin nutrition July 200 Vol. 72, No. 1, 5-14 [3]. Khalafallah AA, Dennis AE, Ogden K, Robertson I, Charlton RH, Bellette JM, et al.Three-year follow-up of a randomised clinical trial of intravenous versus oral iron for anaemia in pregnancy. BMJ Open. 2012; 2(5). pii: e000998. doi: 10.1136/bmjopen-2012- 000998. Print 2012. [4]. Goodman and Gilman’s “The Pharmacological basis of therapeutics”, McGraw – Hill, 10h Edition, 1947. [5]. Plug Cm, Dekkar D, Bult A, “ Complex stability of Ferrous ascorbate in aquesous solution and its significance for iron absorption”, Pharm weekbl Sci., 1984 Dec 14;6(6): 245 – 8. [6]. Agarwal MB, Rathi SA. An open label, randomized, comparative clinical study to assess the efficacy and tolerability of ferrous ascorbate versus carbonyl iron in the treatment of iron deficiency anaemia. Int J Gynecol and Obstet – India, July – August, 2005;8 (4): 23-30. [7]. HERS Study Group, India. The HERS Trial Report: A prospective, open – label study on efficacy and tolerability of Ferrous Ascorbate (Orofer – XT Tablet). Inj J Gynecol and Obstet – India, July- August,2005;8(4): 23 – 30. [8]. Kuropteva ZV, Kudryavtsev ME. Ferrous-ascorbate complexes as carriers of nitric oxide. Gen Physical Biophys. 1997 Mar;16 (1):91 – 6. [9]. al-Momen AK, al-Meshari A, al-Nuaim L, Saddique A, Abotalib Z, Khashogji T, et al. Intravenous iron sucrose complex in the treatment of iron deficiency anemia during pregnancy. Eur J Obstet Gynecol Reprod Biol. 1996 Nov; 69(2): 121-4. [10]. Ragip A, Unlubilgin E, Kandemir O, Yalvac S, Cakir L, Haberal A. Intravenous versus oral iron treatment of anaemia in pregnancy: a randomized trial. Obstet Gynaecol. 2005; 106:1335-1340. [11]. Bayoumeu F, Subiran C, Baka NE, Legagneur H, Monnier P, Laxenaire MC. Iron therapy in iron deficiency anaemia in pregnancy: Intravenous versus oral route. Am J Obstet Gynecol. 2002; 88:3-10. [12]. Froessler B, Cocchiaro C, Saadat-Gilani K, Hodyl N, Dekker G.Intravenous iron sucrose versus oral iron ferrous sulfate for antenatal and post-partum iron deficiency anaemia: a randomised trial. J Matern Fetal Neonatal Med.2012. [13]. Kochhar PK, Kaundal A, Ghosh P. Intravenous iron sucrose versus oral iron in treatment of iron deficiency anemia in pregnancy: A randomized clinical trial. J Obstet Gynaecol Res. 2012 Aug 26. doi: 10.1111/j. 1447-0756.2012.01982.x. [14]. Bencaiova G, Von Mandach U, Zimmermann R Iron prophylaxis in Pregnancy in Preganncy: intravenous route vs oral route. Eur, obstet Gynaecol reprod boil 2009:vol 144:135-9 [15]. Abhilashini G.D. Hasitha S, Reddi R. Intravenous Iron sucrose and oral iron for the treatment of iron deficiency anaemia in pregnancy. Journal of clinical and diagnostic research 2014;Vol May 8:5 [16]. Kripalani A Reeta M et al. Iron Sucrose therapy for anaemia Indian J med Res July 2013;138:78-82