January 2025 Newsletter
Welcome to the January 2025 Edition of Trials & Triumphs: Clinical Research Chronicles!
A new year brings fresh opportunities, and we are excited to continue advancing clinical research in 2025. This month, our Feature Topic explores Hybrid Trials and their role in bridging controlled research with real-world healthcare solutions.
In the Research Highlight section, we explore the Impact of Intravenous vs Oral Iron on Maternal Postpartum Recovery, drawing on key findings from the IVON Trial.
Looking ahead, we are gearing up for key engagements, including the IVON-IS Dissemination Meeting, the LVASA Scientific and Data Analysis Meeting, and the inaugural CAPREMAN Stakeholders Meeting.
Here’s to another year of groundbreaking research and impact. Happy New Year from all of us at CCTRIS!
Sincerely,
Dr. Mobolanle Balogun
Deputy Director (Implementation Science) - CCTRIS
College of Medicine, University of Lagos.
In clinical research, traditional trial designs often operate within fixed boundaries, focusing on either interventional studies (randomised controlled trials) or observational studies. However, hybrid trials have emerged as a powerful approach that combines elements of both, allowing researchers to evaluate interventions while also observing their implementation in real-world settings.
Hybrid trials are designed to address both clinical efficacy and implementation outcomes. They often study how an intervention works in a controlled environment while simultaneously assessing its feasibility, acceptability, or scalability in routine practice. For example, a hybrid trial might evaluate the clinical effectiveness of a new diabetes medication while observing how easily healthcare providers integrate it into their workflows.
There are three common types of hybrid trials:
Hybrid trials are particularly valuable in bridging the gap between research and practice, ensuring that interventions proven effective in controlled settings can be successfully implemented in real-world healthcare systems. This dual focus accelerates the translation of research into practice, reduces delays in adopting new therapies, and generates insights into barriers and facilitators for widespread implementation.
As clinical research evolves, hybrid trials exemplify the importance of designing studies that not only answer “Does it work?” but also “Can it work in the real world?”
Anaemia in pregnancy is a major public health concern, affecting maternal and neonatal outcomes. While intravenous (IV) iron therapy has been shown to replenish iron stores more effectively than oral iron, its role in postpartum recovery—particularly in relation to maternal mental health, breastfeeding, and neonatal well-being—remains unclear. This analysis, an extract from the IVON trial examines how IV ferric carboxymaltose compares with oral ferrous sulphate in influencing key postpartum outcomes among anaemic pregnant women in Nigeria.
This study is part of the IVON trial, a multicentre, open-label, randomised controlled trial conducted across 11 healthcare facilities in Lagos and Kano, Nigeria. A total of 1,056 anaemic pregnant women (Hb <10 g/dL) between 20 and 32 weeks’ gestation were randomly assigned (1:1) to receive either a single IV dose of ferric carboxymaltose (20 mg/kg, max 1000 mg) or oral ferrous sulphate (200 mg thrice daily until six weeks postpartum). Postpartum follow-up visits were conducted at two and six weeks to assess maternal depression using the Edinburgh Postnatal Depression Scale (EPDS), breastfeeding practices, and neonatal health, including immunisation status.
While IV iron was superior in correcting iron deficiency anaemia during pregnancy, it did not significantly impact postpartum depression, breastfeeding rates, or neonatal outcomes compared to oral iron. These findings suggest that while IV iron offers haematological benefits, its influence on broader maternal and neonatal health outcomes requires further investigation.
We are excited to share the findings and lessons learned from the Implementation Research for Intravenous Iron Use in Pregnant and Postpartum Nigerian Women (IVON-IS) project. After three years of implementation, the project has successfully concluded, offering valuable insights into strengthening routine anaemia screening and integrating intravenous iron therapy into maternal healthcare.
The dissemination meeting, scheduled for February 24th, will present key results and discuss the conditions necessary within the health system to ensure effective delivery of intravenous iron to pregnant and postpartum women with moderate to severe anaemia.
In February, we will convene for the LVASA Scientific and Data Analysis Meeting, where we will review findings from the 1,800 Enumeration Areas (EAs) completed, codify collected data, conduct InterVA analysis, and outline the next steps for manuscript development and dissemination. This meeting is scheduled from February 19th to 22nd 2025.
Together with the MRH Research Collective, we are launching the Comprehensive Approach to the Prevention and Management of Maternal Anaemia in Nigeria (CAPREMAN) project, aimed at developing and implementing a comprehensive guideline for maternal anaemia prevention and management. This meeting will provide an opportunity to learn from the IVON-IS experience, introduce the CAPREMAN initiative, and engage key stakeholders—including representatives from the Ministry of Health, Kano, and Kaduna—to drive policy and implementation strategies. This event is scheduled to hold Feb 27th 2025.
Adaptive consent models in clinical research provide a more flexible and participant-centred approach to informed consent, allowing for ongoing engagement and adjustments as a study progresses. Unlike traditional one-time consent, adaptive models enable participants to update their preferences, receive new information as it becomes available, and make informed decisions at different stages of the trial. This approach is particularly useful in long-term studies, precision medicine trials, and research involving emerging technologies, ensuring ethical transparency while enhancing participant autonomy and retention.
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