Intravenous versus oral iron for anaemia among pregnant women in Nigeria (IVON): an open-label, randomised controlled trial.

BACKGROUND: Oral iron for anaemia in pregnancy is often not well tolerated, with poor adherence. Iron administered intravenously might address these tolerance and adherence issues. We investigated the effectiveness and safety of intravenous ferric carboxymaltose versus oral ferrous sulphate on anaemia and iron deficiency among pregnant women in Nigeria. METHODS: We did a multicentre, open-label, parallel, randomised controlled trial of pregnant women (aged 15-49 years) with haemoglobin (Hb) concentrations of less than 10 g/dL at 20-32 weeks' gestation from 11 primary, secondary, or tertiary health facilities in Nigeria (five in Lagos and six in Kano). Exclusion criteria included vaginal bleeding, blood transfusion or major surgery within the past 3 months, symptomatic anaemia, anaemia known to be unrelated to iron deficiency, clinically confirmed malabsorption syndrome, previous hypersensitivity to any form of iron, pre-existing maternal depression or other major psychiatric illness, immune-related diseases, such as systemic lupus erythematosus or rheumatoid arthritis, or severe allergic reactions. Participants were randomly assigned (1:1) by nurses and doctors using a web-based randomisation service to either receive a single dose of intravenous ferric carboxymaltose (20 mg/kg to a maximum of 1000 mg) or oral ferrous sulphate (200 mg; 65 mg elemental iron) three times daily until 6 weeks postpartum. The study was primarily unmasked. Primary outcomes were maternal anaemia (Hb <11 g/dL) at 36 weeks' gestation and preterm birth at before 37 weeks' gestation, with analysis by intention to treat in participants with available data. This study was registered at the ISRCTN registry on Dec 10, 2020 (ISRCTN63484804) and on ClinicalTrials.gov (NCT04976179) on April 7, 2021. FINDINGS: Between Aug 10, 2021, and Dec 15, 2022, 13 724 pregnant women were screened for eligibility. 12 668 were excluded due to ineligibility for inclusion, and 1056 provided consent to participate and were randomly assigned to either the intravenous or oral administration groups. 527 were assigned to the intravenous ferric carboxymaltose group and 529 were assigned to the oral ferrous sulphate group. 518 in the intravenous group were assessed at 36 weeks' gestational age and after 518 deliveries, and 511 completed the 6 weeks postpartum visit. 513 in the oral ferrous sulphate group were assessed at 36 weeks' gestational age and after 512 deliveries, and 501 completed the 6 weeks postpartum visit. No significant difference was found in anaemia at 36 weeks (299 [58%] of 517 in the intravenous group vs 305 [61%] of 503 in the oral group; risk ratio 0·95, 95% CI 0·85-1·06; p=0·36), nor in preterm birth (73 [14%] of 518 vs 77 [15%] of 513; 0·94, 0·70-1·26; p=0·66). There were no significant differences in adverse events. The most common adverse events were diarrhoea (in six participants) and vomiting (in three participants) in the oral group and fatigue (in two participants) and headache (in two participants) in the intravenous group. INTERPRETATION: Although the effect on overall anaemia did not differ, intravenous iron reduced the prevalence of iron deficiency to a greater extent than oral iron and was considered to be safe. We recommend that intravenous iron be considered for anaemic pregnant women in Nigeria and similar settings. FUNDING: Bill & Melinda Gates Foundation.

Prevalence of and risk factors for iron deficiency among pregnant women with moderate or severe anaemia in Nigeria: a cross-sectional study.

BACKGROUND: Anaemia during pregnancy causes adverse outcomes to the woman and the foetus, including anaemic heart failure, prematurity, and intrauterine growth restriction. Iron deficiency anaemia (IDA) is the leading cause of anaemia and oral iron supplementation during pregnancy is widely recommended. However, little focus is directed to dietary intake. This study estimates the contribution of IDA among pregnant women and examines its risk factors (including dietary) in those with moderate or severe IDA in Lagos and Kano states, Nigeria. METHODS: In this cross-sectional study, 11,582 women were screened for anaemia at 20-32 weeks gestation. The 872 who had moderate or severe anaemia (haemoglobin concentration < 10 g/dL) were included in this study. Iron deficiency was defined as serum ferritin level < 30 ng/mL. We described the sociodemographic and obstetric characteristics of the sample and their self-report of consumption of common food items. We conducted bivariate and multivariable logistic regression analysis to identify risk factors associated with IDA. RESULTS: Iron deficiency was observed among 41% (95%CI: 38 - 45) of women with moderate or severe anaemia and the prevalence increased with gestational age. The odds for IDA reduces from aOR: 0.36 (95%CI: 0.13 - 0.98) among pregnant women who consume green leafy vegetables every 2-3 weeks, to 0.26 (95%CI: 0.09 - 0.73) among daily consumers, compared to those who do not eat it. Daily consumption of edible kaolin clay was associated with increased odds of having IDA compared to non-consumption, aOR 9.13 (95%CI: 3.27 - 25.48). Consumption of soybeans three to four times a week was associated with higher odds of IDA compared to non-consumption, aOR: 1.78 (95%CI: 1.12 - 2.82). CONCLUSION: About 4 in 10 women with moderate or severe anaemia during pregnancy had IDA. Our study provides evidence for the protective effect of green leafy vegetables against IDA while self-reported consumption of edible kaolin clay and soybeans appeared to increase the odds of having IDA during pregnancy. Health education on diet during pregnancy needs to be strengthened since this could potentially increase awareness and change behaviours that could reduce IDA among pregnant women with moderate or severe anaemia in Nigeria and other countries.

Equitable abortion care - A challenge for health care providers. Experiences from abortion care encounters with immigrant women in Stockholm, Sweden.

OBJECTIVE: To explore health care providers' experiences of providing care to immigrant women seeking abortion care. METHODS: A qualitative study including interviews with ten midwives and three medical doctors at four abortion clinics in the Stockholm area. Interviews were analysed using thematic analysis. RESULTS: Initially, health care providers were reluctant to make statements concerning the specific needs among immigrant women. Yet, the health care providers sometimes found it challenging to deal with the specific needs among immigrant, mostly non-European, women. Three themes were identified: (1) Reluctance to acknowledge specific needs among immigrant women; (2) Striving to provide contraceptive counselling to immigrant women; (3) Organizational barriers hindering patient-centred abortion care to immigrant women CONCLUSIONS: Health care providers' experiences of the specific needs among non-European, immigrant women are not openly discussed, although they are acknowledged. To achieve equitable access to sexual and reproductive health (SRH), health care providers need to be better equipped when encountering immigrant women in abortion care, especially regarding contraceptive counselling. The potential impact of patients' knowledge, norms and values is not adequately dealt with in the clinical encounter. Moreover, to provide patient-centred care, it is crucial to understand how to develop and implement SRH care that ensures equal access to high-quality care.

Prevention of mother-to-child transmission of HIV in rural Uganda: modelling effectiveness and impact of scaling-up PMTCT services.

BACKGROUND: The reported coverage of any antiretroviral (ARV) prophylaxis for prevention of mother-to-child transmission (PMTCT) has increased in sub-Saharan Africa in recent years, but was still only 60% in 2010. However, the coverage estimate is subject to overestimations since it only considers enrolment and not completion of the PMTCT programme. The PMTCT programme is complex as it builds on a cascade of sequential interventions that should take place to reduce mother-to-child transmission (MTCT) of HIV: starting with antenatal care (ANC), HIV testing, and ARVs for the woman and the baby. OBJECTIVE: The objective was to estimate the number of children infected with HIV in a district population, using empirical data on uptake of PMTCT components combined with data on MTCT rates. DESIGN: This study is based on a population-based cohort of pregnant women recruited in the Iganga-Mayuge Health and Demographic Surveillance Site in rural Uganda 2008-2010. We later modelled different scenarios assuming increased uptake of specific PMTCT components to estimate the impact on MTCT for each scenario. RESULTS: In this setting, HIV infections in children could be reduced by 28% by increasing HIV testing capacity at health facilities to ensure 100% testing among women seeking ANC. Providing ART to all women who received ARV prophylaxis would give an 18% MTCT reduction. CONCLUSIONS: Our results highlight the urgency in scaling-up universal access to HIV testing at all ANC facilities, and the potential gains of early enrolment of all pregnant women on antiretroviral treatment for PMTCT. Further, to determine the effectiveness of PMTCT programmes in different settings, it is crucial to analyse at what stages of the PMTCT cascade that dropouts occur to target interventions accordingly.

Opt-out HIV testing during antenatal care: experiences of pregnant women in rural Uganda.

Two years after the introduction of provider-initiated, opt-out HIV counselling and testing during antenatal care (ANC) in Uganda, HIV testing uptake is still low. This study was carried out to explore pregnant women's experiences of, and views on, the policies for opt-out, and couple HIV testing, and to understand how the policy implementation could be improved in order to increase access to prevention of mother-to-child-transmission (PMTCT) services. The study was conducted at three ANC health facilities at different levels of care in rural eastern Uganda. Data were collected through sit-in observations during ANC and 18 semi-structured interviews with pregnant women receiving ANC, and thereafter analysed using latent content analysis. Pregnant women who received ANC from facilities that provided HIV testing on-site perceived HIV testing as compulsory without actually fully realizing the benefits of HIV testing and PMTCT. No referral for HIV testing or information about testing was given at ANC facilities that lacked HIV testing on-site. A major challenge of couple HIV testing was that pregnant women were made responsible for recruiting their spouses for testing, a precarious dilemma for many women who tried to fulfil health workers' requests without having the power to do so. In order to increase uptake of PMTCT services, the pre-test counselling in groups that precedes the provider-initiated HIV testing should be adjusted to inform women about the benefits of PMTCT. Further, if testing is perceived as compulsory it could potentially deter some women from seeking ANC services. In order to increase HIV testing of male partners new strategies are needed, for example peer-sensitization and male clinics. Moreover, to achieve the desired outcomes of the PMTCT programme, monitoring and evaluation should be built into the programme.

Mistrust in marriage--reasons why men do not accept couple HIV testing during antenatal care- a qualitative study in eastern Uganda.

BACKGROUND: A policy for couple HIV counseling and testing was introduced in 2006 in Uganda, urging pregnant women and their spouses to be HIV tested together during antenatal care (ANC). The policy aims to identify HIV-infected pregnant women to prevent mother-to-child transmission of HIV through prophylactic antiretroviral treatment, to provide counseling, and to link HIV-infected persons to care. However, the uptake of couple testing remains low. This study explores men's views on, and experiences of couple HIV testing during ANC. METHODS: The study was conducted at two time points, in 2008 and 2009, in the rural Iganga and Mayuge districts of eastern Uganda. We carried out nine focus group discussions, about 10 participants in each, and in-depth interviews with 13 men, all of whom were fathers. Data were collected in the local language, Lusoga, audio-recorded and thereafter translated and transcribed into English and analyzed using content analysis. RESULTS: Men were fully aware of the availability of couple HIV testing, but cited several barriers to their use of these services. The men perceived their marriages as unstable and distrustful, making the idea of couple testing unappealing because of the conflicts it could give rise to. Further, they did not understand why they should be tested if they did not have symptoms. Finally, the perceived stigmatizing nature of HIV care and rude attitudes among health workers at the health facilities led them to view the health facilities providing ANC as unwelcoming. The men in our study had several suggestions for how to improve the current policy: peer sensitization of men, make health facilities less stigmatizing and more male-friendly, train health workers to meet men's needs, and hold discussions between health workers and community members. CONCLUSIONS: In summary, pursuing couple HIV testing as a main avenue for making men more willing to test and support PMTCT for their wives, does not seem to work in its current form in this region. HIV services must be better adapted to local gender systems taking into account that incentives, health-seeking behavior and health system barriers differ between men and women.