Comparison of ferric Carboxymaltose and iron sucrose complex for treatment of iron deficiency anemia in pregnancy- randomised controlled trial.
Administration, Intravenous
Adult
Anemia, Iron-Deficiency
/ blood
Erythrocyte Count
Female
Ferric Compounds
/ administration & dosage
Ferric Oxide, Saccharated
/ administration & dosage
Hematinics
/ administration & dosage
Hemoglobins
/ metabolism
Humans
India
Iron
/ blood
Maltose
/ administration & dosage
Pregnancy
Pregnancy Complications
/ blood
Prenatal Care
/ methods
Treatment Outcome
Young Adult
Ferric carboxymaltose
Iron deficiency anemia
Iron sucrose
Pregnancy
Journal
BMC pregnancy and childbirth
ISSN: 1471-2393
Titre abrégé: BMC Pregnancy Childbirth
Pays: England
ID NLM: 100967799
Informations de publication
Date de publication:
04 Feb 2019
04 Feb 2019
Historique:
received:
21
11
2018
accepted:
23
01
2019
entrez:
6
2
2019
pubmed:
6
2
2019
medline:
1
6
2019
Statut:
epublish
Résumé
To evaluate the efficacy and safety of intravenous Ferric Carboxymaltose. (FCM) in comparison with intravenous Iron sucrose complex (ISC) for treatment of iron deficiency anemia in pregnancy. A randomized clinical trial was conducted from (January 2016-August 2017). at a tertiary hospital. Pregnant women diagnosed with moderate to severe iron deficiency anaemia were screened for the study. One hundred patients were randomized to receive either intravenous FCM or ISC. Primary outcome was rise in hemoglobin (Hb) from baseline after 12 weeks. Secondary outcomes were change in RBC indices, serum iron studies, improvement in fatigue scores, number of visits and perinatal outcome. Mean rise in Hb at 12 weeks was significantly higher in FCM group (29 g/L vs 22 g/L; p value < 0.01). FCM was associated with greater improvement in fatigue scores. Number of visits were significantly less in FCM group. No serious adverse events were noted in either group. Treatment with FCM resulted in rapid replenishment of iron stores in pregnant women with significantly higher Hb rise over a 12 week period. The convenient dosing with lesser number of total doses to complete the treatment will lead to better compliance in community setting. CLINICAL TRIAL REGISTRATION ( WWW.CTRI.NIC.IN ): CTRI/2015/09/006224. Registered on 21/07/2017 (Trial registered retrospectively).
Sections du résumé
BACKGROUND
BACKGROUND
To evaluate the efficacy and safety of intravenous Ferric Carboxymaltose. (FCM) in comparison with intravenous Iron sucrose complex (ISC) for treatment of iron deficiency anemia in pregnancy.
METHODS
METHODS
A randomized clinical trial was conducted from (January 2016-August 2017). at a tertiary hospital. Pregnant women diagnosed with moderate to severe iron deficiency anaemia were screened for the study. One hundred patients were randomized to receive either intravenous FCM or ISC. Primary outcome was rise in hemoglobin (Hb) from baseline after 12 weeks. Secondary outcomes were change in RBC indices, serum iron studies, improvement in fatigue scores, number of visits and perinatal outcome.
RESULTS
RESULTS
Mean rise in Hb at 12 weeks was significantly higher in FCM group (29 g/L vs 22 g/L; p value < 0.01). FCM was associated with greater improvement in fatigue scores. Number of visits were significantly less in FCM group. No serious adverse events were noted in either group.
CONCLUSION
CONCLUSIONS
Treatment with FCM resulted in rapid replenishment of iron stores in pregnant women with significantly higher Hb rise over a 12 week period. The convenient dosing with lesser number of total doses to complete the treatment will lead to better compliance in community setting. CLINICAL TRIAL REGISTRATION ( WWW.CTRI.NIC.IN ): CTRI/2015/09/006224. Registered on 21/07/2017 (Trial registered retrospectively).
Identifiants
pubmed: 30717690
doi: 10.1186/s12884-019-2200-3
pii: 10.1186/s12884-019-2200-3
pmc: PMC6360702
doi:
Substances chimiques
Ferric Compounds
0
Hematinics
0
Hemoglobins
0
ferric carboxymaltose
6897GXD6OE
Maltose
69-79-4
Iron
E1UOL152H7
Ferric Oxide, Saccharated
FZ7NYF5N8L
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
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