Abstract

Anaemia in pregnancy increases risks for both maternal and neonatal complications, including death, preterm birth, and low birth weight. Iron tablets are the recommended standard treatment but are often poorly tolerated and adhered to. Intravenous (IV) iron offers an effective and practical alternative with faster replenishment of iron stores and fewer side effects. A randomised controlled trial in Malawi evaluated the safety and efficacy of IV iron compared to standard oral iron supplementation for pregnant women with moderate to severe anaemia in the third trimester (REVAMP-TT). Our qualitative study, embedded within the trial, aimed to explore the factors affecting access to and utilisation of IV iron to treat anaemia in pregnancy within the primary healthcare system of Malawi.

Methodology We conducted in-depth interviews (n=16) and focus group discussions (n=3) with pregnant women who participated in the REVAMP-TT trial, those who withdrew, and their husbands and caregivers. All interviews and discussions were audio-recorded, transcribed, and coded in NVivo 12. We iteratively used reflexive thematic analysis to develop the themes mapped across the supply and demand domains of the Patient-Centered Access to Healthcare framework.

Results We identified five key themes under supply-side barriers, including i) lack of transparency in REVAMP-TT trial procedures and processes, ii) lack of continued community sensitisation about IV iron, iii) long distances from home to the health facilities, iv) long waiting times for procedures and IV iron administration, and v) pregnant women non-compliance with appointments. Four demand-side obstacles were highlighted, including i) myths and misconceptions about IV iron, ii) prevailing cultural norms like concealing pregnancy, iii) lack of social and financial support from husbands, and iv) physical discomfort when receiving IV iron. Five facilitators emerged from the supply side, including the i) availability of clear information about anaemia and antenatal care outreach services, ii) pregnant women were not pressured to participate in the REVAMP-TT trial, iii) flexible health facility opening hours and appointment mechanism, iv) perceived effectiveness and benefits of IV iron and v) healthcare providers’ interpersonal quality and skills. Four demand-side enablers included i) health literacy about anaemia, ii) social value and a sense of autonomy, iii) peer support, iv) available social and financial support from family or husband, and iv) caregiver support.

Conclusion In conclusion, our study underscores the potential of IV iron therapy to address anaemia in pregnancy in LMICs like Malawi. Patient-centred approaches, improved health literacy, and strengthening health systems are vital for optimising intervention uptake and ensuring equitable access to antenatal care interventions, ultimately improving the health outcomes for mother and child.

Contributions to literature Our study demonstrates the practical aspects and challenges of implementing an IV iron intervention in a low-resource setting, including how the Malawian healthcare system could be strengthened to effectively deliver IV iron in local healthcare facilities. It provides a blueprint for implementation in similar contexts to integrate this treatment into existing healthcare delivery structures.

Our study offers insights into how cultural norms and beliefs shape health-seeking behaviour and practices, contributing to our understanding of how to tailor health interventions to cultural contexts. Additionally, it highlights facilitators, such as local health facilities, that can improve the uptake of IV iron therapy in rural and underserved areas, showcasing how these approaches can be scaled up to enhance maternal health.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

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Clinical Protocols

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Funding Statement

The Bill and Melinda Gates Foundation supported this research program under the REVAMP-TT TRIAL [INV-004505]. However, the funders had no role in study design, data collection and analysis, publication decisions, or manuscript preparation.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Not Applicable

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

We received ethics approval (P.08/20/3114) from the University of Malawi’s College of Medicine Research and Ethics Committee. All participants signed the informed consent form.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Not Applicable

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Not Applicable

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Not Applicable

Data Availability

The datasets generated and analysed during the current study could be available from the corresponding author on reasonable request with permission from the College of Medicine Research Ethics Committee (comrecmedcol.mw)

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AbbreviationsDHODistrict Health OfficeFGDFocus group discussionFCMFerric carboxymaltoseHICHigh-income countryIDIIn-depth interviewIVIntravenousLMICLow-middle-income countryMRIMagnetic Resonance ImagingPCAHPatient-Centred Access to HealthcareREVAMP-ISRandomised controlled trial on the effect of intravenous iron on moderate and severe anaemia in pregnant women in the third trimester – Implementation ScienceREVAMP-TTRandomised controlled trial on the effect of intravenous iron on moderate and severe anaemia in pregnant women in the third trimesterRTAReflexive thematic analysisSDGSustainable Development Goals