Objective Data regarding low maternal haemoglobin concentration and severe maternal morbidity (SMM) are limited and potentially biased. This study evaluated the relation between early maternal haemoglobin concentration and SMM or maternal mortality. Design Population-based cohort study. Setting Ontario, Canada, in a public healthcare system. Population 737 393 births with a routine outpatient haemoglobin measured at a calculated gestational age of 2-16 weeks. Methods The relation between early-pregnancy outpatient blood haemoglobin concentration and each study outcome was expressed as adjusted relative risks (aRR) and absolute risk differences (aRD), with 95% confidence intervals (CI), generated by modified Poisson regression. Main outcome measures The primary outcome was SMM or maternal mortality, from 23 weeks' gestation to 42 days postpartum. Results The mean (SD) haemoglobin concentration was 126.9 (9.3) g/l. Overall, SMM or death occurred in 13 514 pregnancies (1.8%). Relative to a haemoglobin level of 125-129 g/l, the aRR was 1.07 (95% CI 1.02-1.13) and aRD (0.09%, 95% CI 0.01-0.18) at 120-124 g/l; aRR 1.31 (95% CI 1.17-1.46) and aRD 0.47% (95% CI 0.24-0.69) at 105-109 g/l; and aRR 4.53 (95% CI 3.59-5.72) and aRD 5.94% (95% CI 4.12-7.76) at <90 g/l. In all, 5961 women (0.8%) required red cell transfusion, with significantly higher risks at all haemoglobin concentrations below 125-129 g/l, peaking at a haemoglobin level <90 g/l (aRR 11.82, 95% CI 9.30-15.03). Conclusion There is a gradual increase in the risk of SMM or death, as well as red cell transfusion, starting from the lower level of the normal range of haemoglobin of non-pregnant women.
Objective Data regarding low maternal haemoglobin concentration and severe maternal morbidity (SMM) are limited and potentially biased. This study evaluated the relation between early maternal haemoglobin concentration and SMM or maternal mortality. Design Population-based cohort study. Setting Ontario, Canada, in a public healthcare system. Population 737 393 births with a routine outpatient haemoglobin measured at a calculated gestational age of 2-16 weeks. Methods The relation between early-pregnancy outpatient blood haemoglobin concentration and each study outcome was expressed as adjusted relative risks (aRR) and absolute risk differences (aRD), with 95% confidence intervals (CI), generated by modified Poisson regression. Main outcome measures The primary outcome was SMM or maternal mortality, from 23 weeks' gestation to 42 days postpartum. Results The mean (SD) haemoglobin concentration was 126.9 (9.3) g/l. Overall, SMM or death occurred in 13 514 pregnancies (1.8%). Relative to a haemoglobin level of 125-129 g/l, the aRR was 1.07 (95% CI 1.02-1.13) and aRD (0.09%, 95% CI 0.01-0.18) at 120-124 g/l; aRR 1.31 (95% CI 1.17-1.46) and aRD 0.47% (95% CI 0.24-0.69) at 105-109 g/l; and aRR 4.53 (95% CI 3.59-5.72) and aRD 5.94% (95% CI 4.12-7.76) at <90 g/l. In all, 5961 women (0.8%) required red cell transfusion, with significantly higher risks at all haemoglobin concentrations below 125-129 g/l, peaking at a haemoglobin level <90 g/l (aRR 11.82, 95% CI 9.30-15.03). Conclusion There is a gradual increase in the risk of SMM or death, as well as red cell transfusion, starting from the lower level of the normal range of haemoglobin of non-pregnant women.
“…An advantage of intravenous iron therapy is that it corrects Hb/Hct and iron stores concurrently and rapidly. Recent systematic reviews indicate that intravenous iron therapy in pregnancy allows more complete achievement of desired Hb concentrations [105,106]. A number of intravenous iron preparations are available, with different dosing schedules, and a detailed discussion of these is outside the scope of the current review.…”
Section: Approach To Iron Administration In Pregnancymentioning
A normal pregnancy consumes 500-800 mg of iron from the mother. Premenopausal women have a high incidence of marginal iron stores or iron deficiency (ID), with or without anemia, particularly in the less developed world. Although pregnancy is associated with a "physiologic" anemia largely related to maternal volume expansion; it is paradoxically associated with an increase in erythrocyte production and erythrocyte mass/kg. ID is a limiting factor for this erythrocyte mass expansion and can contribute to adverse pregnancy outcomes. This review summarizes erythrocyte and iron balance observed in pregnancy; its implications and impact on mother and child; and provides an overview of approaches to the recognition of ID in pregnancy and its management, including clinically relevant questions for further investigation.
“…In contrast, the use of intravenous iron bypasses these hepcidin-mediated pathways and can result in improvements in haemoglobin concentration, functional performance, and quality of life in patients with anaemia of chronic disease seen with kidney failure, 7 heart failure, 8 inflammatory bowel disease, 9 and women's health. 10 , 11 …”
Summary
Background
Preoperative anaemia affects a high proportion of patients undergoing major elective surgery and is associated with poor outcomes. We aimed to test the hypothesis that intravenous iron given to anaemic patients before major open elective abdominal surgery would correct anaemia, reduce the need for blood transfusions, and improve patient outcomes.
Methods
In a double-blind, parallel-group randomised trial, we recruited adult participants identified with anaemia at preoperative hospital visits before elective major open abdominal surgery at 46 UK tertiary care centres. Anaemia was defined as haemoglobin less than 130 g/L for men and 120 g/L for women. We randomly allocated participants (1:1) via a secure web-based service to receive intravenous iron or placebo 10–42 days before surgery. Intravenous iron was administered as a single 1000 mg dose of ferric carboxymaltose in 100 mL normal saline, and placebo was 100 mL normal saline, both given as an infusion over 15 min. Unblinded study personnel prepared and administered the study drug; participants and other clinical and research staff were blinded to treatment allocation. Coprimary endpoints were risk of the composite outcome of blood transfusion or death, and number of blood transfusions from randomisation to 30 days postoperatively. The primary analysis included all randomly assigned patients with data available for the primary endpoints; safety analysis included all randomly assigned patients according to the treatment received. This study is registered, ISRCTN67322816, and is closed to new participants.
Findings
Of 487 participants randomly assigned to placebo (n=243) or intravenous iron (n=244) between Jan 6, 2014, and Sept 28, 2018, complete data for the primary endpoints were available for 474 (97%) individuals. Death or blood transfusion occurred in 67 (28%) of the 237 patients in the placebo group and 69 (29%) of the 237 patients in the intravenous iron group (risk ratio 1·03, 95% CI 0·78–1·37; p=0·84). There were 111 blood transfusions in the placebo group and 105 in the intravenous iron group (rate ratio 0·98, 95% CI 0·68–1·43; p=0·93). There were no significant differences between the two groups for any of the prespecified safety endpoints.
Interpretation
Preoperative intravenous iron was not superior to placebo to reduce need for blood transfusion when administered to patients with anaemia 10–42 days before elective major abdominal surgery.
Funding
UK National Institute of Health Research Health Technology Assessment Program.
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