Frequency to Non-Compliance to Oral Iron Therapy in Pregnancy and Common Factors Leading to it

OBJECTIVES: The objective of this study was to determine frequency of non-compliance to oral iron therapy in pregnancy and common factors leading to it. METHODOLOGY: It was a cross-sectional study done in the Department of Obstetrics and Gynecology of Lady Willington Hospital Lahore, Pakistan. The duration of this study was six months i.e., 3rd October 2019 to 2nd March 2020. All antenatal patients between ages of 18 to 45 years presented in the obstetrics outdoors or admitted in the ward were included in this study. A total of 245 patients were included in this study by consecutive non-probability sampling. Patients with gynecological problems, patients dependent on others for their medication cost, patients with psychiatric illness or physical disability were excluded. Post stratification Chi-square test was applied keeping P-value ≤0.05 as significant RESULTS: Among 245 patients, mean age was 27±2.16 years. Iron supplement used by 245 patients was analyzed as 159 (65%) patients had used the iron supplement while 86 (35%) patients didn’t use iron supplements (P-value 0.001). Iron supplement used by 245 patients was analyzed and only 93 (38%) patients had used the iron supplement while 152 (62%) patients didn’t use iron supplements. CONCLUSION: The coverage of antenatal iron and folic acid supplements is very low in the surveyed districts of Pakistan due to lack of parental education and older aged women belonging to poor households.

A COMPARATIVE STUDY OF INTRAVENOUS IRON SUCROSE VERSUS ORAL IRON THERAPY IN IRON DEFICIENCY ANEMIA DURING POSTPARTUM PERIOD

Introduction: Anemia is the commonest major contributing factor in maternal mortality and morbidity in developing countries and according to World Health Organization (WHO) criteria, it contributes to 20% of maternal deaths. Anemia in pregnancy defined as hemoglobin level <11 gm/dl (7.45 mmol/L) and hematocrit less than 33% (WHO). Aim: To compare the efficacy of oral iron ferrous sulphate therapy with intravenous iron sucrose therapy in the treatment of iron deficiency anemia during postpartum period. Material & Methods: This was a prospective randomized comparative clinical trial single center study conducted on 200 postpartum women aged >18 years (after normal delivery or LSCS) within 10 days of delivery with Hb level more or equal to 6 gm/dl but less than 10 gm/dl were included in the study. This was a one year study conducted during 1st December 2018 to 30th November 2019. Results : There was a significant increase in the hemoglobin level in both the groups i.e. in IV iron group, from 8.26 ±1.03gm/dl on day 1 to 11.62±0.94gm/dl on day 45 as compared to oral iron group, from 8.24±1.09gm/dl on day 1 to 11.07±1.14gm/dl on day 45; and serum ferritin level from 41.69±40.45ng/ml on day 1 to 77.34±41.60ng/ml on day 45 in IV iron group as compared to the oral iron group from 22.20±8.82ng/ml on day 1 to 31.72±9.72 ng/ml on day 45. So, there was a rapid increase in both hemoglobin and serum ferritin levels in IV iron group as compared to the oral iron group. Conclusion: Intravenous iron sucrose administration increases the hemoglobin level and serum ferritin more rapidly in compare to the oral intake of ferrous sulphate in women with iron deficiency anemia in postpartum women in our study. Keywords: Iron deficiency anemia, Intravenous iron sucrose, Serum ferritin, Maternal mortality.

Intravenous versus Oral iron for Iron-Deficiency Anemia in Pregnancy (IVIDA): A Randomized Controlled Trial

Objective Iron-deficiency anemia (IDA) can have serious consequences for mothers and babies. Iron supplementation is recommended, but the administration route is controversial. We sought to conduct a randomized controlled trial (RCT) testing the effectiveness and safety of intravenous (IV) iron compared with oral iron on perinatal outcomes in pregnant women with IDA. Study Design This open-label RCT randomized patients with IDA (hemoglobin [hgb] <10 g/dL and ferritin <30 ng/mL) at 24 to 34 weeks' to oral iron or single 1,000-mg dose of IV low-molecular weight iron dextran over one hour. The primary outcome was maternal anemia at delivery (hgb < 11 g/dL). Secondary outcomes were mild/moderate or severe adverse reactions, maternal hgb and ferritin at delivery, blood transfusion, gestational age at delivery, birth weight, neonatal hgb and ferritin, and composite neonatal morbidity. Analysis was as per protocol. Results The trial was stopped early for logistical reasons, and the data analyzed as preliminary data to inform a larger, potentially externally funded, definitive trial. Of 55 patients approached, 38 consented. Of these, 15 were withdrawn: 5 received IV iron from their primary obstetrician after being randomized to oral iron and 10 declined to receive IV iron. Of the remaining 23 patients, who were included in the analytic population, 13 received oral iron and 10 received IV iron. The rate of maternal anemia at delivery (hgb < 11 g/dL) was high overall but significantly reduced with IV iron (40 vs. 85%, p = 0.039). Rates of maternal hgb < 10 g/dL were significantly lower in the IV iron group (10 vs. 54%, p = 0.029). There were no severe adverse reactions and similar rates of mild/moderate reactions between groups. Conclusion IV iron reduces rates of anemia at the time of admission for delivery, supporting a larger RCT comparing IV versus oral iron for the treatment of IDA of pregnancy powered for definitive clinical outcomes. However, issues uncovered in this RCT suggest that patient, clinician, and systems-level barriers associated with different IDA treatment modalities must be considered prior to conducting a larger RCT. This study is registered with clinicaltrials.gov with identifier no.: NCT03438227. Key Points

A comparative study of efficacy, safety and compliance of intravenous ferric carboxymaltose versus iron sucrose in the treatment of iron deficiency anaemia of pregnancy

Iron deficiency is the most common cause of anaemia worldwide and is associated with significant maternal and fetal morbidity. Current options for treatment include oral iron supplementation which can be ineffective and poorly tolerated, intravenous iron which can be used in patients who are intolerant to or unresponsive to oral iron and red blood cell transfusions which carry an inherent risk because of which it should be avoided. Intravenous iron therapy may reduce the requirement for allogenic blood transfusion. Ferric carboxymaltose is a new intravenous iron formulation promising to be more effective and as safe as iron sucrose. It may even have a better compliance as it offers the administration of a much higher iron dosage at a time.The study was designed to compare the efficacy and safety of IV ferric carboxymaltose versus iron sucrose in the treatment of iron deficiency anaemia of pregnant women with moderate anaemia in the second and third trimester.A hospital based randomized prospective study was done from July 2013 to June 2015 in the department of Obstetrics and Gynaecology, A.J. Institute of Medical Sciences, Mangalore. Baseline haemoglobin, peripheral smear and serum ferritin levels were measured to diagnose iron deficiency anaemia. 60 pregnant women who met the inclusion criteria and who formed the study subjects were randomly allocated into two groups comprising of 30 in Group C (Received ferric carboxymaltose) and 30 in Group S (Received iron sucrose). Outcome was assessed by measuring haemoglobin 3 weeks after treatment and a comparison of the safety and efficacy between the two groups was made. In the present study the commonest age group was 21 to 30 years: 80% in group C and 73.3% in group S and mean age of the study population in group C and S was comparable (25.2±3.54 vs 24.8±4.58 years). The socio demographic characteristics, obstetric history, vitals and pretreatment haemoglobin were comparable in both the groups (p&#62;0.050). The post treatment haemoglobin levels in 63.3% of the women in group C compared to 46.7% in group S were found to be 11 or more and mean post treatment haemoglobin levels were comparable in group C and group S (11.016±0.789 vs 10.73±0.821 gm%; p=0.174). In the present study, post treatment mean increase in haemoglobin levels was noted between 2.0 to 2.5 gm% in 43.3% of the women in group C compared to 50.0% in group S. Ferric carboxymaltose administration in pregnant women in the second and third trimesters is well tolerated and is not associated with any clinical safety concerns. Both ferric carboxymaltose and iron sucrose have a comparable safety profile even when ferric carboxymaltose was administered in a much higher dosage compared to iron sucrose. Ferric carboxymaltose should be considered as the drug of choice, if i.v. iron treatment becomes necessary in the second or third trimester of pregnancy.

FERALGINE™ a New Oral iron Compound

Management of iron deficiency (ID) and iron deficiency anemia (IDA) is primarily focused to remove, when possible, the underlying cause of ID; subsequently its treatment is primary focused on iron stores repletion. Ferrous sulphate (FS) remains the mainstay of treatment and it is recommended as the first-line treatment of ID and IDA in children as in adults by all guidelines of scientific societies. However the effectiveness of FS is largely compromised by increased adverse effects, poor compliance and discontinuation of treatment. A new oral iron source named FERALGINE™ (FBC-A) has been recently developed. This new molecule is a patented co-processed one-to-one ratio compound between Ferrous Bysglicinate Chelate (FBC) and Sodium Alginate (AA), obtained by using a spray drying technology. The data presented in this short review highlight the efficacy and safety of the treatment with FBC-A and support its use in adult patients with IDA. Furthermore the present review also provides preliminary evidence to suggest FBC-A as first-line treatment for ID/IDA in patients with celiac disease (CD) or inflammatory bowel diseases (IBD).

Variability in Oral Iron Prescription and the Effect on Spanish Mothers’ Health: A Prospective Longitudinal Study

Background: No consensus exists regarding the hemoglobin (Hb) values that define postpartum anemia. Knowledge is currently lacking regarding prescription and consumption practices, which prevents evaluating the rational use of iron supplementation postpartum. Aim: In this study, our objective was to describe this practice and analyze its association with maternal health outcomes. Methods: A prospective observational study was conducted with 1010 women aged between 18 and 50. The hemoglobin value on the first postpartum day; the prescription schedule at hospital discharge; iron consumption; and data on hemoglobin, serum ferritin, maternal fatigue, type of breastfeeding, and perceived health six weeks after delivery were collected. Findings: Oral iron was prescribed to 98.1% of mothers with anemia and 75.8% without anemia. At the same Hb value, the maximum amount of total iron prescribed was between 8 and 10 times greater than the minimum amount. Iron intake was significantly lower than prescribed (p < 0.01). At six weeks, anemic mothers who took iron presented a 3.6-, 3-, and 2.4-times lower probability of iron deficiency, anemia, and abandoning breastfeeding, respectively. Discussion: Postpartum iron intake shows a protective effect on iron deficiency and anemia at six weeks, but not on fatigue or self-perceived health level. Conclusion: We conclude that there is wide variability in the prescription regimen. Oral iron supplementation can benefit mothers with anemia and harm those without. Subsequent studies should further explore the Hb figure that better discriminates the need for postpartum iron.