Treatment Of Iron Deficiency Anemia In Pregnancy Research Articles

Intravenous versus oral iron for iron deficiency anaemia in pregnant Nigerian women (IVON): study protocol for a randomised hybrid effectiveness-implementation trial

BackgroundAnaemia in pregnancy is highly prevalent in African countries. High-dose oral iron is the current recommended treatment for pregnancy-related iron deficiency anaemia (IDA) in Nigeria and other African countries. This oral regimen is often poorly tolerated and has several side effects. Parenteral iron preparations are now available for the treatment of IDA in pregnancy but not widely used in Africa.The IVON trial is investigating the comparative effectiveness and safety of intravenous ferric carboxymaltose versus oral ferrous sulphate standard-of-care for pregnancy-related IDA in Nigeria. We will also measure the implementation outcomes of acceptability, feasibility, fidelity, and cost-effectiveness for intravenous ferric carboxymaltose.MethodsThis is an open-label randomised controlled trial with a hybrid type 1 effectiveness-implementation design, conducted at 10 health facilities in Kano (Northern) and Lagos (Southern) states in Nigeria. A total of 1056 pregnant women at 20–32 weeks’ gestational age with moderate or severe anaemia (Hb < 10g/dl) will be randomised 1:1 into two groups. The interventional treatment is one 1000-mg dose of intravenous ferric carboxymaltose at enrolment; the control treatment is thrice daily oral ferrous sulphate (195 mg elemental iron daily), from enrolment till 6 weeks postpartum.Primary outcome measures are (1) the prevalence of maternal anaemia at 36 weeks and (2) infant preterm birth (<37 weeks’ gestation) and will be analysed by intention-to-treat. Maternal full blood count and iron panel will be assayed at 4 weeks post-enrolment, 36 weeks’ gestation, delivery, and 6 weeks postpartum. Implementation outcomes of acceptability, feasibility, fidelity, and cost will be assessed with structured questionnaires, key informant interviews, and focus group discussions.DiscussionThe IVON trial could provide both effectiveness and implementation evidence to guide policy for integration and uptake of intravenous iron for treating anaemia in pregnancy in Nigeria and similar resource-limited, high-burden settings. If found effective, further studies exploring different intravenous iron doses are planned.Trial registration ISRCTN registry ISRCTN63484804. Registered on 10 December 2020Clinicaltrials.govNCT04976179. Registered on 26 July 2021The current protocol version is version 2.1 (080/080/2021).

Iron deficiency anemia in pregnancy.

Anemia in pregnancy is associated with increased maternal and neonatal morbidity. There is increasing awareness amongst obstetricians about the need to screen for iron deficiency anemia (IDA), as well as growing literature on diagnosis and treatment. This review aims to summarize causes, consequences, treatment, and evaluation of IDA in pregnancy. National guidelines provide varying guidance on diagnosis and treatment of IDA in pregnancy. Serum ferritin is a helpful adjunct for the diagnosis of IDA. Oral iron remains an option for treatment; absorption is improved with every other day dosing and is effective for patients able to tolerate. Emerging studies on modern generations of intravenous (IV) iron demonstrate shorter infusion times and improved safety profiles. Notably, recent UK guidelines provide consideration for universal IV iron supplementation for treatment of anemia beyond 34 weeks of pregnancy. Iron, in dietary, oral, and IV forms, has been found effective in resolving anemia in pregnancy. Pregnant people with IDA in the third trimester are more likely to benefit from IV iron. Future studies designed and powered to assess maternal and perinatal morbidity indicators and blood transfusion rates can strengthen recommendations.

Pharmacological management of anaemia in pregnancy: a review

AbstractAnaemia in pregnancy is defined as a haemoglobin (Hb) level of &lt;110 g/L before 20 weeks' gestation or &lt;105 g/L at or after 20 weeks' gestation. Anaemia is a common complication of pregnancy and is associated with maternal, foetal and infant morbidity and in rare circumstances mortality. Iron deficiency anaemia (IDA) is the most common cause of anaemia in Australian pregnant women, although other causes should be considered. Prevention of IDA and adequate treatment for all pregnant women with IDA is recommended. First line treatment of IDA in pregnancy is oral iron replacement. Recent knowledge has suggested lower doses of iron supplementation may be as effective as higher doses. Intravenous iron is a second line treatment for IDA. We present a review of the causes of anaemia, a suggested algorithm for investigation of anaemia in pregnancy and a review of treatment options reflecting current understanding of the physiology of iron absorption.

REGAIN STUDY: Retrospective Study to Assess the Effectiveness, Tolerability, and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia in Pregnant Women.

Iron deficiency anemia (IDA) during pregnancy arises because of preexisting inadequate stores or complex physiological changes and can lead to serious maternal and fetal complications. Oral iron, either as iron sulfate or fumarate, with or without folic acid, is the most commonly used treatment for IDA in pregnancy. Intravenous (IV) iron has a role in the treatment of IDA in pregnancy, particularly in women who present late, display severe anemia (Hb ≤ 9 g/dL), or risk factors, and are intolerant/noncompliant of oral iron. Previously, administration of IV iron was minimal, owing to potentially serious anaphylactic reactions. Recently, new IV iron products have been developed, offering better compliance, tolerability, efficacy, and a good safety profile. Our study aimed to assess the effectiveness, safety, and tolerability of IV ferric carboxymaltose (FCM) in the treatment of IDA in pregnant women in the UAE. Data from 1001 pregnant women who received at least one administration of FCM (500, 1000, or 1500 mg) during their second or third trimester of pregnancy (2 years backward from study initiation) were collected retrospectively from electronic medical records at Corniche Hospital, Abu Dhabi, UAE. Results showed that 41.4% of the women were able to achieve an increase of ≥2 g/dL in blood hemoglobin overall. A change of ≥2 g/dL was achieved by 27.5% of women administered a dose of 500 mg, 39.2% of women administered a dose of 1000 mg, and 63.9% of women administered a dose of 1500 mg of IV FCM. This indicates a directly proportional relationship between increasing IV FCM dose and the increase of ≥2 g/dL in blood hemoglobin. A total of 7 (0.7%) women reported mild, nonserious adverse events during the study. Within the limits of this retrospective study, IV FCM therapy was safe and effective in increasing the mean hemoglobin of pregnant women with IDA.

A Prospective Randomised Controlled Trial of a Single Intravenous Infusion of Ferric Carboxymaltose vs Single Intravenous Iron Polymaltose or Daily Oral Ferrous Sulphate in the Treatment of Iron Deficiency Anaemia in Pregnancy

Iron deficiency anaemia (IDA) is the most common nutritional deficiency affecting pregnant women worldwide. This study aims to compare the efficacy and safety of a newly available intravenous (IV) iron preparation, ferric carboxymaltose (FCM), against IV iron polymaltose (IPM), and standard oral iron (ferrous sulphate) for the treatment of IDA in pregnancy. This is an open-labelled prospective randomised controlled trial (RCT) with intention-to-treat analysis conducted at a primary health care facility with a single tertiary referral centre in Launceston. Tasmania, Australia. A 3-arm randomised controlled trial was conducted comparing a single IV infusion of 1000mg of FCM (n = 83 patients) over 15 minutes against a single IV infusion of 1000mg of IPM (n = 82) over 2 hours against 325mg daily oral ferrous sulphate (n = 81) until delivery, for the treatment of IDA in pregnancy. A total of 246 consecutive pregnant women were recruited between September 2013 and July 2014. The median age was 28 years, with a median and mean gestation of 27 weeks. The median serum ferritin was 9µg/L, with a mean of 13µg/L. The mean haemoglobin (Hb) was 114g/L. The primary outcome was the change in ferritin and Hb levels at 4 weeks after intervention. Secondary outcomes included ferritin and Hb improvements at predelivery, safety, tolerability, quality of life (QoL), cost utility, and fetal outcomes. The mean Hb level differences between the baseline intervention time point and 4 weeks thereafter were significantly higher in the FCM versus the oral group by 4.35g/L (95% CI: 1.64-7.05; P = 0.0006) and in the IPM vs the oral group by 4.08g/L (95% CI: 1.57-6.60; P = 0.0005), but not different between the FCM and IPM groups (0.26g/L; 95% CI: −2.59 to 3.11; P = 0.9740). The mean ferritin level differences were significantly higher at 4 weeks in the FCM vs oral iron group by 166µg/L (95% CI: 138-194; P < 0.0001) and in the IPM vs oral iron group by 145µg/L (95% CI: 109-1180, P < 0.0001), but not between the 2 IV groups (21.5µg/L; 95% CI: −23.9 to 66.9; P = 0.4989). Administration of IV FCM during pregnancy was safe and better tolerated than IV IPM or oral iron. Compliance to oral iron was the lowest amongst treatment groups with one-third of the patients missing doses of daily iron tablets. Significant improvement in overall QoL scores was observed in both IV iron supplement groups by achieving normal ferritin following effective and prompt repletion of iron stores, compared to the oral iron group (P = 0.04, 95% CI: 21.3, 1.8). The overall cost utility of IV FCM and IV IPM appear to be similar to oral iron. There were no differences in the fetal outcomes between the 3 trial arms.In conclusion, this study demonstrates that a single IV iron infusion is an effective and safe option for treatment of IDA during pregnancy. FCM was more convenient than other treatments. Rapid parenteral iron repletion can improve iron stores, Hb levels and QoL in pregnant women, with ongoing benefits until delivery. Integration of IV iron for IDA in pregnancy can potentially improve pregnancy outcomes for the mother. Update of guidelines to integrate the use of new IV iron preparations in pregnancy is warranted.

Management of Iron Deficiency Anemia in Pregnancy in India.

Iron deficiency anemia (IDA) continues to be the commonest etiology of anemia in pregnancy. The prevalence of iron deficiency (ID) in pregnant Indian women is amongst the highest in the world. Untreated iron deficiency (ID) has significant adverse feto-maternal consequences. Plethora of investigations are available for diagnosis of IDA, each having specific advantages and disadvantages when used in the pregnancy setting. Therapy for ID includes dietary modification, oral iron supplementation, intravenous iron and blood transfusion. Newer parenteral iron preparations are safe and there is mounting evidence to suggest their use in frontline settings for pregnancy associated IDA in the second and third trimester. Through this review, we suggest an algorithm for diagnosis and treatment of IDA in pregnancy depending on the severity of anemia and period of gestation suited for widespread use in resource limited settings. Also, we recommend ways for increasing public awareness and tackling this health issue including the observance of "National Anemia Awareness and Treatment Day."

A comparative prospective study to assess the efficacy and safety of iron sucrose versus iron sorbitol citric acid in pregnant women with iron deficiency anemia in a tertiary care hospital

Background: The prevalence of iron deficiency anemia (IDA) is 58% among pregnant women in developing countries. According to the recent national guidelines, intramuscular iron sorbitol citric acid (ISCA) complex is one of the firstline drugs for treating moderate IDA in pregnancy. A novel intravenous preparation, iron sucrose promises to be more effective as it causes faster replenishment of iron stores and rapid rise of hemoglobin (Hb). Aims and Objective: The aim of this study is to evaluate the efficacy and safety of iron sucrose versus ISCA complex in IDA of pregnant women. Materials and Methods: A total of 127 pregnant women whose Hb between 7 and 9 g/dl were recruited in the study. They were randomized into two groups to receive iron sucrose (intravenous) and ISCA (I.M), respectively. Hematological parameters were measured at baseline, 4 weeks and 8 weeks of treatment. Results: Mean rise in Hb and serum ferritin from baseline was 3.15 ± 0.08 (P < 0.0001) and 14.1 ± 2.6 (P < 0.0001) at the end of 8 weeks, respectively, with ISCA. Mean rise in Hb and serum ferritin from baseline was 3.36 ± 0.06 (P < 0.0001) and 16.28 ± 3.1 (P < 0.0001) at the end of 8 weeks with iron sucrose. 18% and 42% of pregnant women in iron sucrose and ISCA group experienced side effects, respectively. Conclusion: The rise in hemoglobin and serum ferritin was significant in iron sucrose group with fewer adverse effects. Hence, iron sucrose can be a safe and effective agent in the treatment of IDA in pregnancy.