Acceptability of IV iron treatment for iron deficiency anaemia in pregnancy in Nigeria: a qualitative study with pregnant women, domestic decision-makers, and health care providers.

BACKGROUND: Anaemia in pregnancy causes a significant burden of maternal morbidity and mortality in sub-Saharan Africa, with prevalence ranging from 25 to 45% in Nigeria. The main treatment, daily oral iron, is associated with suboptimal adherence and effectiveness. Among pregnant women with iron deficiency, which is a leading cause of anaemia (IDA), intravenous (IV) iron is an alternative treatment in moderate or severe cases. This qualitative study explored the acceptability of IV iron in the states of Kano and Lagos in Nigeria. METHODS: We purposively sampled various stakeholders, including pregnant women, domestic decision-makers, and healthcare providers (HCPs) during the pre-intervention phase of a hybrid clinical trial (IVON trial) in 10 healthcare facilities across three levels of the health system. Semi-structured topic guides guided 12 focus group discussions (140 participants) and 29 key informant interviews. We used the theoretical framework of acceptability to conduct qualitative content analysis. RESULTS: We identified three main themes and eight sub-themes that reflected the prospective acceptability of IV iron therapy. Generally, all stakeholders had a positive affective attitude towards IV iron based on its comparative advantages to oral iron. The HCPs noted the effectiveness of IV iron in its ability to evoke an immediate response and capacity to reduce anaemia-related complications. It was perceived as a suitable alternative to blood transfusion for specific individuals based on ethicality. However, to pregnant women and the HCPs, IV iron could present a higher opportunity cost than oral iron for the users and providers as it necessitates additional time to receive and administer it. To all stakeholder groups, leveraging the existing infrastructure to facilitate IV iron treatment will stimulate coherence and self-efficacy while strengthening the existing trust between pregnant women and HCPs can avert misconceptions. Finally, even though high out-of-pocket costs might make IV iron out of reach for poor women, the HCPs felt it can potentially prevent higher treatment fees from complications of IDA. CONCLUSIONS: IV iron has a potential to become the preferred treatment for iron-deficiency anaemia in pregnancy in Nigeria if proven effective. HCP training, optimisation of information and clinical care delivery during antenatal visits, uninterrupted supply of IV iron, and subsidies to offset higher costs need to be considered to improve its acceptability. Trial registration ISRCTN registry ISRCT N6348 4804. Registered on 10 December 2020 Clinicaltrials.gov NCT04976179. Registered on 26 July 2021.

Low blood level in pregnancy is of public health importance and with common occurrence worldwide, but with a higher rate in low resource settings where its burden greatly affects both the mother and her baby. This low blood level is usually caused by poor intake of an iron-rich diet. It could lead to fatigue, decreased work capacity, and dizziness if not detected. Without treatment, this condition could affect the baby, possibly leading to its sudden demise in the womb, immediately after birth, or even the woman's death.The use of oral iron has been the primary treatment; however, it is associated with significant side effects, which have led to poor compliance. Fortunately, an alternative therapy in the form of a drip has been shown to overcome these challenges. However, it is not routinely used in countries like Nigeria. Moreover, being effective is different from being utilised. Therefore, this study was conducted to understand the factors that will make this treatment widely accepted.We interviewed pregnant women, family support and health care providers in 10 health facilities in Lagos and Kano States, Nigeria. Our findings revealed good attitudes to iron drip. However, its inclusion into routine antenatal health talk, training of health care providers, availability of space, drugs and health workers who will provide this care, and ensuring this drug is of low cost are some of the efforts needed for this treatment to be accepted.

Evidence-based obstetric management of women with sickle cell disease in low-income countries.

Pregnancy in women with sickle cell disease (SCD) is fraught with complications, some of which are life-threatening. Managing pregnancy in these women can be challenging, especially with poor resources, which is often the case in low-income countries. In Nigeria, for instance, up to 90% of patients pay out of pocket for medical care due to the poorly developed health insurance system, and this worsens the morbidity and mortality associated with this condition. We describe a pragmatic approach to routinely managing pregnant women with SCD in the antenatal period, showing the feasibility of effective management of these high-risk pregnancies in limited-resource settings. We also present the case of a pregnant Nigerian woman with SCD who has intrauterine growth restriction (IUGR) and acute chest syndrome (ACS), conditions that are life-threatening for the fetus and the mother, respectively, and require prompt intervention. We highlight how we successfully managed this woman in a cost-effective manner by employing relatively inexpensive tests for diagnosis and treating her effectively with oxygen, appropriate antibiotics and manual exchange blood transfusion for the ACS, and finger pulse oximeters to monitor oxygen saturation. We explore pathophysiological concepts to IUGR in women with SCD and briefly discuss the appropriate mode of delivery, including the options for pain relief in labor.

Intravenous versus oral iron for iron deficiency anaemia in pregnant Nigerian women (IVON): study protocol for a randomised hybrid effectiveness-implementation trial.

BACKGROUND: Anaemia in pregnancy is highly prevalent in African countries. High-dose oral iron is the current recommended treatment for pregnancy-related iron deficiency anaemia (IDA) in Nigeria and other African countries. This oral regimen is often poorly tolerated and has several side effects. Parenteral iron preparations are now available for the treatment of IDA in pregnancy but not widely used in Africa. The IVON trial is investigating the comparative effectiveness and safety of intravenous ferric carboxymaltose versus oral ferrous sulphate standard-of-care for pregnancy-related IDA in Nigeria. We will also measure the implementation outcomes of acceptability, feasibility, fidelity, and cost-effectiveness for intravenous ferric carboxymaltose. METHODS: This is an open-label randomised controlled trial with a hybrid type 1 effectiveness-implementation design, conducted at 10 health facilities in Kano (Northern) and Lagos (Southern) states in Nigeria. A total of 1056 pregnant women at 20-32 weeks' gestational age with moderate or severe anaemia (Hb < 10g/dl) will be randomised 1:1 into two groups. The interventional treatment is one 1000-mg dose of intravenous ferric carboxymaltose at enrolment; the control treatment is thrice daily oral ferrous sulphate (195 mg elemental iron daily), from enrolment till 6 weeks postpartum. Primary outcome measures are (1) the prevalence of maternal anaemia at 36 weeks and (2) infant preterm birth (<37 weeks' gestation) and will be analysed by intention-to-treat. Maternal full blood count and iron panel will be assayed at 4 weeks post-enrolment, 36 weeks' gestation, delivery, and 6 weeks postpartum. Implementation outcomes of acceptability, feasibility, fidelity, and cost will be assessed with structured questionnaires, key informant interviews, and focus group discussions. DISCUSSION: The IVON trial could provide both effectiveness and implementation evidence to guide policy for integration and uptake of intravenous iron for treating anaemia in pregnancy in Nigeria and similar resource-limited, high-burden settings. If found effective, further studies exploring different intravenous iron doses are planned. TRIAL REGISTRATION: ISRCTN registry ISRCTN63484804 . Registered on 10 December 2020 Clinicaltrials.gov NCT04976179 . Registered on 26 July 2021 The current protocol version is version 2.1 (080/080/2021).

Analysis of serum placental growth factor levels in preeclamptic and normotensive pregnant women in Lagos, Nigeria: a worthwhile screening tool?

The clinical usefulness of serum placental growth factor (PlGF) as a predictive biomarker of preeclampsia is currently being examined. However, there are still conflicting results in the literature. We assessed the association between maternal low PlGF levels and the occurrence and severity of preeclampsia. This was an analytical cross-sectional study conducted among 60 women with preeclampsia, and an equal number of matched normotensive pregnant women. PlGF concentrations were analysed using the ELISA method. Bivariate and multivariate analysis was used to test for the association between low maternal PlGF levels and the occurrence of preeclampsia and its severity. Statistical significance was reported at p < .05. The study showed that having a low maternal PlGF level (Adjusted OR 14.23; 95%CI 8.06, 29.71) together with being primigravid (Adjusted OR 3.97; 95%CI 1.03, 6.18) and having an unbooked pregnancy (Adjusted OR 8.07; 95%CI 2.06, 19.40) were independently associated with preeclampsia. We established an association between low maternal PlGF levels and preeclampsia, but no similar association with severe preeclampsia. The use of PlGF as a potential predictive marker and a reliable screening tool may have a profound implication on the prevention of preeclampsia and the subsequent reduction in its associated morbidity and mortality.Impact statementWhat is already known on this subject? The utility of serum placental growth factor (PlGF) as a predictive biomarker of preeclampsia is currently being examined, however, there are conflicting results of its clinical usefulness in the literature.What do the results of this study add? This study that assessed the association between maternal low PlGF levels and the occurrence and severity of preeclampsia showed that having a low maternal PlGF level together with being primigravid and having an unbooked pregnancy were independently associated with the occurrence of preeclampsia. However, we were unable to establish any significant relationship between maternal PlGF and the severity of preeclampsia.What are the implications of these findings for clinical practice and/or further research? We opined that the use of PlGF as a potential predictive marker and a reliable screening tool may have a profound clinical implication on the prevention and reduction in the associated morbidity and mortality of preeclampsia. However, there is an urgent need for more robust longitudinal studies to define the regulation of placental vascular development and the clinical usefulness of maternal serum PlGF and other placental biomarkers as potential screening tools for preeclampsia among black African women.

Sexually transmitted infections in pregnancy - An update on Chlamydia trachomatis and Neisseria gonorrhoeae.

Routine screening for Chlamydia and gonococcal infection in pregnancy is not widespread, especially in low- and middle-income countries (LMICs), despite their potential adverse consequences on pregnancy outcome. We conducted a systematic literature search of three major databases to review current literature surrounding Chlamydia trachomatis and Neisseria gonorrhoeae infections in pregnancy. We discuss the epidemiology and burden of both infections, detection methods, potential adverse feto-maternal and infant outcomes and provide an overview of treatment options. A total of 67 articles met the inclusion criteria. The prevalence of C. trachomatis and N. gonorrhoeae across all trimesters ranged between 1.0%-36.8% and 0-14.2% worldwide, respectively. The most common diagnostic method is the Nucleic acid amplification test (NAAT). In pregnancy, chlamydia is associated with preterm birth, spontaneous miscarriage, stillbirth and neonatal conjunctivitis, while gonorrhoea is mainly associated with preterm birth and stillbirth. Amoxicillin, erythromycin and azithromycin showed similar efficacy in the treatment of chlamydia in pregnancy, while ceftriaxone and cefixime were effective in treating gonorrhoea in pregnancy. Being largely asymptomatic infections in women, we opine that detection strategies with locally appropriate tools should be combined with the syndromic approach in LMICs, where there is a high burden of disease.

Good clinical practice advice for the management of pregnant women with suspected or confirmed COVID-19 in Nigeria.

The impact on healthcare services in settings with under-resourced health systems, such as Nigeria, is likely to be substantial in the coming months due to the COVID-19 pandemic, and maternity services still need to be prioritized as an essential core health service. The healthcare system should ensure the provision of safe and quality care to women during pregnancy, labor, and childbirth, and at the same time, maternity care providers including obstetricians and midwives must be protected and prioritized to continue providing care to childbearing women and their babies during the pandemic. This practical guideline was developed for the management of pregnant women with suspected or confirmed COVID-19 in Nigeria and other low-resource countries.