Addition of oral iron bisglycinate to intravenous iron sucrose for the treatment of postpartum anemia-randomized controlled trial.


Journal

American journal of obstetrics and gynecology
ISSN: 1097-6868
Titre abrégé: Am J Obstet Gynecol
Pays: United States
ID NLM: 0370476

Informations de publication

Date de publication:
12 2021
Historique:
received: 03 03 2021
revised: 11 06 2021
accepted: 17 06 2021
pubmed: 26 6 2021
medline: 18 12 2021
entrez: 25 6 2021
Statut: ppublish

Résumé

Studies that have compared the effectiveness of oral with intravenous iron supplements to treat postpartum anemia have shown mixed results. The superiority of one mode of treatment vs the other has yet to be demonstrated. Therefore, despite guidelines and standards of care, treatment approaches vary across practices. A single 500 mg dose of iron sucrose, which is higher than what is usually administered, has not been evaluated to treat postpartum moderate to severe anemia. This study aimed to compare the efficacy of intravenous iron sucrose alone with intravenous iron sucrose in combination with oral iron bisglycinate supplementation in treating moderate to severe postpartum anemia. A randomized controlled trial was conducted between February 2015 and June 2020. Women with postpartum hemoglobin level of ≤9.5 g/dL were treated with 500 mg intravenous iron sucrose after an anemia workup, which ruled out other causes for anemia. In addition to receiving intravenous iron, women were randomly allocated to receive either 60 mg of oral iron bisglycinate for 45 days or no further iron supplementation. The primary outcome was hemoglobin level at 6 weeks after delivery. Secondary outcomes were iron storage parameters and quality of life. Of 158 patients who participated, 63 women receiving intravenous and oral iron, and 44 women receiving intravenous iron-only, completed the study and were included in the analysis. Baseline and obstetrical characteristics were similar between the study cohorts. Although statistically significant, postpartum hemoglobin levels were only 0.4 g/dL higher in the intravenous and oral iron than intravenous iron-only cohort (12.4 g/dL vs 12.0 g/dL, respectively; P=.03), with a respective increase from baseline of 4.2 g/dL vs 3.7 g/dL (P=.03). There was no difference in the rate of women with hemoglobin level of <12.0 or 11.0 g/dL. Iron storage and health quality were not different between the cohorts. Oral iron treatment was associated with 29% rate of adverse effects. Compliance and satisfaction from treatment protocol were high in both cohorts. Intravenous 500 mg iron sucrose treatment alone is sufficient to treat postpartum anemia without the necessity of adding oral iron treatment.

Sections du résumé

BACKGROUND
Studies that have compared the effectiveness of oral with intravenous iron supplements to treat postpartum anemia have shown mixed results. The superiority of one mode of treatment vs the other has yet to be demonstrated. Therefore, despite guidelines and standards of care, treatment approaches vary across practices. A single 500 mg dose of iron sucrose, which is higher than what is usually administered, has not been evaluated to treat postpartum moderate to severe anemia.
OBJECTIVE
This study aimed to compare the efficacy of intravenous iron sucrose alone with intravenous iron sucrose in combination with oral iron bisglycinate supplementation in treating moderate to severe postpartum anemia.
STUDY DESIGN
A randomized controlled trial was conducted between February 2015 and June 2020. Women with postpartum hemoglobin level of ≤9.5 g/dL were treated with 500 mg intravenous iron sucrose after an anemia workup, which ruled out other causes for anemia. In addition to receiving intravenous iron, women were randomly allocated to receive either 60 mg of oral iron bisglycinate for 45 days or no further iron supplementation. The primary outcome was hemoglobin level at 6 weeks after delivery. Secondary outcomes were iron storage parameters and quality of life.
RESULTS
Of 158 patients who participated, 63 women receiving intravenous and oral iron, and 44 women receiving intravenous iron-only, completed the study and were included in the analysis. Baseline and obstetrical characteristics were similar between the study cohorts. Although statistically significant, postpartum hemoglobin levels were only 0.4 g/dL higher in the intravenous and oral iron than intravenous iron-only cohort (12.4 g/dL vs 12.0 g/dL, respectively; P=.03), with a respective increase from baseline of 4.2 g/dL vs 3.7 g/dL (P=.03). There was no difference in the rate of women with hemoglobin level of <12.0 or 11.0 g/dL. Iron storage and health quality were not different between the cohorts. Oral iron treatment was associated with 29% rate of adverse effects. Compliance and satisfaction from treatment protocol were high in both cohorts.
CONCLUSION
Intravenous 500 mg iron sucrose treatment alone is sufficient to treat postpartum anemia without the necessity of adding oral iron treatment.

Identifiants

pubmed: 34171389
pii: S0002-9378(21)00704-3
doi: 10.1016/j.ajog.2021.06.069
pii:
doi:

Substances chimiques

Ferrous Compounds 0
Hematinics 0

Banques de données

ClinicalTrials.gov
['NCT02458625']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

668.e1-668.e9

Informations de copyright

Copyright © 2021 Elsevier Inc. All rights reserved.

Auteurs

Enav Yefet (E)

Department of Obstetrics and Gynecology, Emek Medical Center, Afula, Israel; Department of Obstetrics and Gynecology, The Baruch Padeh Medical Center, Poriya, Tiberias, Israel; Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel. Electronic address: enavy1@gmail.com.

Sobhiya Mruat Rabah (S)

Department of Obstetrics and Gynecology, Emek Medical Center, Afula, Israel; Department of Obstetrics and Gynecology, Nazareth Hospital EMMS, Nazareth, Israel.

Nitzan Dana Sela (ND)

Department of Obstetrics and Gynecology, Emek Medical Center, Afula, Israel.

Sally Hosary Mhamed (S)

Department of Obstetrics and Gynecology, Emek Medical Center, Afula, Israel.

Avishag Yossef (A)

Department of Obstetrics and Gynecology, Emek Medical Center, Afula, Israel.

Zohar Nachum (Z)

Department of Obstetrics and Gynecology, Emek Medical Center, Afula, Israel; The Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.

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