scholarly journals Protocol for a multicentre, parallel-group, open-label randomised controlled trial comparing ferric carboxymaltose with the standard of care in anaemic Malawian pregnant women: the REVAMP trial

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e053288
Author(s):  
Martin N Mwangi ◽  
Glory Mzembe ◽  
Ernest Moya ◽  
Sabine Braat ◽  
Rebecca Harding ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Research Ethics ◽  
Controlled Trial ◽  
Intravenous Iron ◽  
Standard Of Care ◽  
Ethics Committee ◽  
Oral Iron ◽  
Ferric Carboxymaltose ◽  
Second Trimester ◽  
In Pregnancy

IntroductionAnaemia in pregnancy remains a critical global health problem, affecting 46% of pregnant women in Africa and 49% in Asia. Oral iron therapy requires extended adherence to achieve correction of anaemia and replenishment of iron stores. Ferric carboxymaltose (FCM) is a recently established intravenous iron formulation associated with substantial advantages in safety, speed of delivery and total dose deliverable in a single infusion. We aim to determine whether FCM given once during the second trimester of pregnancy compared with standard oral iron distributed through routine antenatal services is effective and safe for treatment of moderate to severe maternal anaemia in sub-Saharan Africa.Methods and analysisThe randomized controlled trial of the effect of intravenous iron on anaemia in Malawian pregnant women (REVAMP) is a two-arm confirmatory individually randomised trial set in Blantyre and Zomba districts in Malawi. The trial will randomise 862 women in the second trimester of pregnancy with a capillary haemoglobin concentration below 100.0 g/L. The study comprises two arms: (a) intravenous FCM (20 mg/kg up to 1000 mg) given once at randomisation, and (b) standard of care oral iron (65 mg elemental iron two times per day) for 90 days (or the duration of pregnancy, whichever is shorter) provided according to local healthcare practices. Both arms receive sulfadoxine-pyrimethamine as intermittent preventive treatment in pregnancy. The primary outcome is the prevalence of anaemia (Hb <110.0 g/L) at 36 weeks’ gestation. Secondary outcomes include birth weight, gestation duration and safety outcomes, including clinical malaria, serious perinatal events and postpartum haematologic and health-related outcomes in the mother and child.Ethics and disseminationEthical approval was granted by the Research Ethics Committee (COMREC P.02/18/2357) in Malawi and the Human Research Ethics Committee (WEHI: 18/02), Melbourne, Australia. The protocol is registered with the Australian and New Zealand Clinical Trials Registry. The results will be shared with the local community that enabled the research, and also to the international fora.Trial registration numberACTRN12618001268235; Pre-results.

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

Anemia ◽  
2019 ◽  
Vol 2019 ◽  
pp. 1-5
Author(s):  
Saleema Wani ◽  
Mariyam Noushad ◽  
Shabana Ashiq
Keyword(s):  
Retrospective Study ◽  
Iron Deficiency ◽  
Pregnant Women ◽  
Iron Deficiency Anemia ◽  
Oral Iron ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Blood Hemoglobin ◽  
Iv Iron ◽  
In Pregnancy

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.

scholarly journals Changes in Smoking Habits in Pregnant Women During COVID-19 Pandemic. A Comparison of Two Cohorts

2021 ◽  
Author(s):  
Javier Llorca ◽  
Carolina Lechosa-Muñiz ◽  
Veronica Vejo-Iandalia ◽  
Sonia Vilanova-Fernández ◽  
Trinidad Dierssen-Sotos ◽  
...  
Keyword(s):  
Clinical Research ◽  
Pregnant Women ◽  
Research Ethics ◽  
Smoking Prevalence ◽  
Age Groups ◽  
Ethics Committee ◽  
Trial Registration ◽  
Smoking In Pregnancy ◽  
Step Down ◽  
In Pregnancy

Abstract Background: Although smoking in pregnancy has well known deleterious effects, about 50% women who smoked out of the pregnancy continue to smoke while pregnant. The main is to study changes in smoking in pregnancy during covid-19 pandemic.Methods: We compare two cohorts of pregnant women: one recruited in 2018 (pre-pandemic cohort) and one recruited from March 2020 on (pandemic cohort).Results: The percentage of women who smoked decreased from 13% in the pre-pandemic cohort to 8% in the pandemic cohort (p<0.001). This step-down was similar in all age groups and both employed and unemployed/no active women. Among women in the pandemic cohort, those whose pregnancy began after March-2020 (when the pandemic was declared) reported 1% smoking prevalence, which is much lower than smoking prevalence in women whose pregnancy began before the pandemic was declared.Conclusion: Smoking was less frequent in pregnancies during the covid-19 pandemic and even less frequent in women whose pregnancy began after the pandemic was declared. The effect that lockdown, stay-at-home orders or healthier behaviour habits could have had on smoking in pregnancy would require further research.Trial registration: The study was approved by the Clinical Research Ethics Committee of Cantabria (reference: 2020.174).

scholarly journals Evaluation of efficacy of injection ferric carboxymaltose in pregnant women

2020 ◽  
Vol 9 (7) ◽  
pp. 2900
Author(s):  
Rupali M. Sabale ◽  
Reena J. Wani ◽  
Rashmi Jalvee
Keyword(s):  
Iron Deficiency ◽  
Pregnant Women ◽  
Iron Deficiency Anaemia ◽  
Oral Treatment ◽  
Intravenous Iron ◽  
Oral Iron ◽  
Ferric Carboxymaltose ◽  
Iron Group ◽  
Deficiency Anaemia ◽  
Iv Iron

Background: Iron deficiency anaemia (IDA) continues to be a very common problem in developing countries leading to a spectrum of adverse events in pregnant women. The objective of this study was to determine the efficacy, side effects and tolerance of ferric carboxymaltose as compared to available iron preparations for the prophylaxis and treatment of mild to moderate iron deficiency anaemia during pregnancy.Methods: One-year clinical study (from June 2017 to May 2018). A total 100 patients were enrolled after matching inclusion and exclusion criteria. The efficacy assessment was performed during 4, 8, and 12 weeks of starting therapy. If the patient is not responding to therapy in either arm as documented by no rise or fall in haemoglobin levels patients may be removed from study for other therapy. Treatment duration up to 12 weeks. Safety and efficacy follow-up visit at 4, 8 and 12 weeks. Institutional ethics committee permission was taken.Results: On intra-group comparisons there was significant increase in haemoglobin levels at 8 and 12 weeks in oral iron group as compared to day 1 haemoglobin levels while there was significant increase in haemoglobin levels at 4, 8 and 12 weeks in IV iron group as compared to day 1 haemoglobin levels. On intergroup comparisons between oral and IV iron group, there was significant increase in haemoglobin levels at 4, 8 and 12 weeks in IV iron group as compared oral iron group haemoglobin levels.Conclusions: Intravenous iron therapy with ferric carboxymaltose causes significant improvement in haemoglobin more quickly and more effective in correcting iron deficiency anaemia in pregnancy compared to oral treatment in terms of increase in haemoglobin levels at 4, 8 and 12 weeks. Intravenous ferric carboxymaltose is safe and effective option for pregnant women with iron deficiency anaemia.

scholarly journals A Randomized controlled trial of the Effect of intraVenous iron on Anaemia in Malawian Pregnant women (REVAMP): Statistical analysis plan

2021 ◽  
Vol 5 ◽  
pp. 174
Author(s):  
Rebecca Harding ◽  
Ricardo Ataide ◽  
Martin N Mwangi ◽  
Julie A Simpson ◽  
Glory Mzembe ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Statistical Analysis ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intravenous Iron ◽  
Statistical Analysis Plan ◽  
Statistical Analyses ◽  
Second Trimester ◽  
Randomized Controlled ◽  
Detailed Statistical Analysis

Background: Anaemia affects more than half of Africa’s pregnancies. Standard care, with oral iron tablets, often fails to achieve results, with compliance and gastrointestinal side-effects being a significant issue. In recent years, intravenous iron formulations have become safe, effective, and quick to administer, allowing the complete iron requirements of pregnancy to be provided in one 15-minute infusion. The Randomized controlled trial of the Effect of intraVenous iron on Anaemia in Malawian Pregnant women (REVAMP) will evaluate whether a modern intravenous iron formulation, ferric carboxymaltose (FCM), given once during the second trimester is effective and safe in improving maternal and neonatal outcomes for treatment of moderate to severe anaemia in sub-Saharan Africa.   The objective was to publish the detailed statistical analysis plan for the REVAMP trial prior to unblinding the allocated treatments and performing the analysis.   Methods: REVAMP is a multicentre, two-arm, open-label, parallel-group randomized control trial (RCT) in 862 pregnant women in their second trimester. The trial statistician developed the statistical analysis plan in consultation with the trial management team based on the protocol, data collection forms, and study outcomes available in the blinded study database.   Results: The detailed statistical analysis plan will support the statistical analyses and reporting of the REVAMP trial after unblinding the treatment allocations.   Conclusions: A statistical analysis plan allows for transparency as well as reproducibility of reporting and statistical analyses.

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

2021 ◽  
Vol 8 (4) ◽  
pp. 448-453
Author(s):  
Vathsala Kamath ◽  
Naimisha Reddy ◽  
Nishita Shettian
Keyword(s):  
Iron Deficiency ◽  
Pregnant Women ◽  
Iron Deficiency Anaemia ◽  
Intravenous Iron ◽  
Post Treatment ◽  
Oral Iron ◽  
Iron Sucrose ◽  
Ferric Carboxymaltose ◽  
Third Trimester ◽  
Deficiency Anaemia

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.

scholarly journals Ferric carboxymaltose vs. oral iron in the treatment of pregnant women with iron deficiency anemia: an international, open-label, randomized controlled trial (FER-ASAP)

2017 ◽  
Vol 45 (4) ◽  
Author(s):  
Christian Breymann ◽  
Nils Milman ◽  
Anna Mezzacasa ◽  
Roubert Bernard ◽  
Joachim Dudenhausen
Keyword(s):  
Iron Deficiency ◽  
Pregnant Women ◽  
Social Functioning ◽  
Iron Deficiency Anemia ◽  
Controlled Trial ◽  
Oral Iron ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
First Line ◽  
Open Label

AbstractObjective:To compare the efficacy and safety of intravenous ferric carboxymaltose (FCM) with first-line oral ferrous sulfate (FS) in pregnant women with iron deficiency anemia (IDA).Materials and methods:Pregnant women (n=252; gestational weeks 16–33) with IDA were randomized 1:1 to FCM (1000–1500 mg iron) or FS (200 mg iron/day) for 12 weeks. The primary objective was to compare efficacy; secondary objectives included safety and quality of life.Results:Hemoglobin (Hb) levels improved at comparable rates across both treatments; however, significantly more women achieved anemia correction with FCM vs. FS [Hb ≥11.0 g/dL; 84% vs. 70%; odds ratio (OR): 2.06, 95% confidence interval (CI): 1.07, 3.97; P=0.031] and within a shorter time frame (median 3.4 vs. 4.3 weeks). FCM treatment significantly improved vitality (P=0.025) and social functioning (P=0.049) prior to delivery. Treatment-related adverse events were experienced by 14 (FCM; 11%) and 19 (FS; 15%) women, with markedly higher rates of gastrointestinal disorders reported with FS (16 women) than with FCM (3 women). Newborn characteristics were similar across treatments.Conclusions:During late-stage pregnancy, FCM may be a more appropriate option than first-line oral iron for rapid and effective anemia correction, with additional benefits for vitality and social functioning.

scholarly journals RAPIDIRON: Reducing Anaemia in Pregnancy in India A 3-Arm, Randomized-Controlled Trial Comparing The Effectiveness of Oral Iron With Single-Dose Intravenous Iron In The Treatment of Iron Deficiency Anaemia In Pregnant Women And Reducing Low Birth Weight Deliveries.

2021 ◽  
Author(s):  
Richard Derman ◽  
Shivaprasad Goudar ◽  
Simal Thind ◽  
Sudhir Bhandari ◽  
Zubair Aghai ◽  
...  
Keyword(s):  
Single Dose ◽  
Iron Deficiency ◽  
Iron Deficiency Anaemia ◽  
Controlled Trial ◽  
Intravenous Iron ◽  
Oral Iron ◽  
Reproductive Age ◽  
Deficiency Anaemia ◽  
Randomized Controlled ◽  
In Pregnancy

Abstract Background: Anaemia is a worldwide problem and iron deficiency is the most common cause. In pregnancy, anaemia increases the risk of adverse maternal, foetal and neonatal outcomes.India’s anaemia rate is among the highest in the world with India’s National Family Health Survey indicating over 50% of pregnant women were affected by anaemia. India’s Anaemia Mukt Bharat-Intensified National Iron Plus Initiative aims to reduce the prevalence of anaemia among reproductive-age women, adolescents and children by 3% per year and facilitate the achievement of a Global World Health Assembly 2025 objective to achieve a 50% reduction of anaemia among women of reproductive age. However, preliminary results of the NFHS-5 survey completed in 2020 indicate that anaemia rates are increasing in some states and these targets are unlikely to be achieved. With oral iron being the first-line treatment for iron deficiency anaemia (IDA) in pregnancy, these results are likely to be impacted by the side effects, poor adherence to tablet ingestion and low therapeutic impact of oral iron. These reports suggest a new approach to treating IDA, specifically the importance of single-dose intravenous iron infusions, may be the key to India effectively reaching its targets for anaemia reduction. Methods: This 3-arm, randomized controlled trial is powered to report two primary outcomes. The first is to assess whether a single dose of two different intravenous formulations administered early in the second trimester of pregnancy to women with moderate IDA will result in a higher percentage of participants achieving a normal for pregnancy Hb concentration at 30-34 weeks’ gestation or just prior to delivery when compared to participants taking standard doses of oral iron. The second is a clinical outcome of low birth weight (LBW) (< 2500 grams), with a hypothesis that the risk of LBW delivery will be lower in the intravenous iron arms when compared to the oral iron arm. Discussion: The RAPIDIRON trial will provide evidence to determine if a single-dose intravenous iron infusion is more effective and economically feasible in reducing IDA in pregnancy than the current standard of care.Trial registration: Clinical Trials Registry – India: CTRI/2020/09/027730. Registered 10 September 2020, http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=46801&EncHid=&userName=anemia%20in%20pregnancy

scholarly journals RAPIDIRON: Reducing Anaemia in Pregnancy in India—a 3-arm, randomized-controlled trial comparing the effectiveness of oral iron with single-dose intravenous iron in the treatment of iron deficiency anaemia in pregnant women and reducing low birth weight deliveries

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Richard J. Derman ◽  
Shivaprasad S. Goudar ◽  
Simal Thind ◽  
Sudhir Bhandari ◽  
Zubair Aghai ◽  
...  
Keyword(s):  
Single Dose ◽  
Iron Deficiency ◽  
Iron Deficiency Anaemia ◽  
Controlled Trial ◽  
Intravenous Iron ◽  
Oral Iron ◽  
Reproductive Age ◽  
Deficiency Anaemia ◽  
Randomized Controlled ◽  
In Pregnancy

Abstract Background Anaemia is a worldwide problem and iron deficiency is the most common cause. In pregnancy, anaemia increases the risk of adverse maternal, foetal and neonatal outcomes. India’s anaemia rate is among the highest in the world with India’s National Family Health Survey indicating over 50% of pregnant women were affected by anaemia. India’s Anaemia Mukt Bharat-Intensified National Iron Plus Initiative aims to reduce the prevalence of anaemia among reproductive-age women, adolescents and children by 3% per year and facilitate the achievement of a Global World Health Assembly 2025 objective to achieve a 50% reduction of anaemia among women of reproductive age. However, preliminary results of the NFHS-5 survey completed in 2020 indicate that anaemia rates are increasing in some states and these targets are unlikely to be achieved. With oral iron being the first-line treatment for iron deficiency anaemia (IDA) in pregnancy, these results are likely to be impacted by the side effects, poor adherence to tablet ingestion and low therapeutic impact of oral iron. These reports suggest a new approach to treating IDA, specifically the importance of single-dose intravenous iron infusions, may be the key to India effectively reaching its targets for anaemia reduction. Methods This 3-arm, randomized controlled trial is powered to report two primary outcomes. The first is to assess whether a single dose of two different intravenous formulations administered early in the second trimester of pregnancy to women with moderate IDA will result in a higher percentage of participants achieving a normal for pregnancy Hb concentration at 30–34 weeks’ gestation or just prior to delivery when compared to participants taking standard doses of oral iron. The second is a clinical outcome of low birth weight (LBW) (< 2500 g), with a hypothesis that the risk of LBW delivery will be lower in the intravenous iron arms when compared to the oral iron arm. Discussion The RAPIDIRON trial will provide evidence to determine if a single-dose intravenous iron infusion is more effective and economically feasible in reducing IDA in pregnancy than the current standard of care. Trial registration Clinical Trials Registry – India CTRI/2020/09/027730. Registered on 10 September 2020, http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=46801&EncHid=&userName=anemia%20in%20pregnancy

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