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Abstract Background Iron deficiency anaemia is common among pregnant women in Nigeria. The standard treatment is oral iron therapy, which can be sub-optimal due to side effects. Intravenous ferric carboxymaltose (FCM) is an evidenced-based alternative treatment with a more favourable side effect profile requiring administration according to a standardized protocol. In this study, we assessed the fidelity of administering a single dose of FCM according to protocol and identified factors influencing implementation fidelity. Methods We used a mixed-method approach with a sequential explanatory design nested in a clinical trial across 11 facilities in Lagos and Kano States, Nigeria. Guided by a conceptual framework of implementation fidelity, we quantitatively assessed adherence to protocol by directly observing every alternate FCM administration, using an intervention procedure checklist, and compared median adherence by facility and state. Qualitative fidelity assessment was conducted via in-depth interviews with 14 skilled health personnel (SHP) from nine purposively selected health facilities, using a semi-structured interview guide. We analyzed quantitative data using descriptive and inferential statistics in Stata and used thematic analysis to analyze the transcribed interviews in NVivo. Results A total of 254 FCM administrations were observed across the 11 study sites, with the majority in secondary (63%), followed by primary healthcare facilities (PHCs) (30%). Overall, adherence to FCM administration as per protocol was moderate (63%) and varied depending on facility level. The lowest level of adherence was observed in PHCs (36%). Median, adherence level showed significant differences by facility level (p = 0.001) but not by state (p = 0.889). Teamwork and availability of protocols are facilitation strategies that contributed to high fidelity. However, institutional/ logistical barriers are contextual factors that influenced the varied fidelity levels observed in some facilities. Conclusions Collaborative teams and access to operating protocols resulted in high fidelity in some facilities. However, in some PHCs, fidelity to FCM was low due to contextual factors and intervention complexities, thereby influencing the quality of delivery. In Nigeria, scale-up of FCM will require attention to staff strength, teamwork and availability of administration protocols, in order to optimize its impact on anaemia in pregnancy.

Abstract 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

Abstract 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 (

Abstract Background Endometriosis is the presence of active ectopic endometrial glands and stroma at other sites outside the uterine cavity. It is a common cause of chronic pelvic pain which is sometimes debilitating, and inflammation is one of the known triggers of endometriosis. Interleukins 6 and 16 (IL-6 and IL-16) are proinflammatory cytokines which play essential roles in inflammatory diseases. We therefore investigated the relationship between genetic polymorphisms of interleukins 6 and 16, and the development of endometriosis in Nigerian women. Method One hundred and thirty (130) consenting women were consecutively enrolled, sixty-five (65) of whom had endometriosis and 65 age-matched women as reference group, surgically confirmed as not having endometriosis. Spectrophotometric determination of serum concentrations of Interleukins 6 and 16 was carried out and the genotyping of IL-6 (rs1800795) and IL-16 (rs4778889, rs11556218, rs4072111) genes were performed using TaqMan assays. Results Serum IL-16 concentration was significantly higher in women with severe chronic pelvic pain compared to those with mild pain (p = 0.023). The C allele of rs4778889 was associated with endometriosis (OR: 1.80, 95% CI: 1.08 – 3.02, p = 0.024). Conclusion Serum IL-16 and IL-16 rs4778889 may be important markers for endometriosis in Nigerian, and by extension, African women. Multicentre African studies would clarify this.

Objectives The COVID-19 pandemic affected provision and use of maternal health services. This study describes changes in obstetric complications, referrals, stillbirths and maternal deaths during the first year of the pandemic and elucidates pathways to these changes.Design Prospective observational mixed-methods study, combining monthly routine data (March 2019–February 2021) and qualitative data from prospective semi-structured interviews. Data were analysed separately, triangulated during synthesis and presented along three country-specific pandemic periods: first wave, slow period and second wave.Setting Six referral maternities in four sub-Saharan African countries: Guinea, Nigeria, Tanzania and Uganda.Participants 22 skilled health personnel (SHP) working in the maternity wards of various cadres and seniority levels.Results Percentages of obstetric complications were constant in four of the six hospitals. The percentage of obstetric referrals received was stable in Guinea and increased at various times in other hospitals. SHP reported unpredictability in the number of referrals due to changing referral networks. All six hospitals registered a slight increase in stillbirths during the study period, the highest increase (by 30%–40%) was observed in Uganda. Four hospitals registered increases in facility maternal mortality ratio; the highest increase was in Guinea (by 158%), which had a relatively mild COVID-19 epidemic. These increases were not due to mortality among women with COVID-19. The main pathways leading to these trends were delayed care utilisation and disruptions in accessing care, including sub-optimal referral linkages and health service closures.Conclusions Maternal and perinatal survival was negatively affected in referral hospitals in sub-Saharan Africa during COVID-19. Routine data systems in referral hospitals must be fully used as they hold potential in informing adaptations of maternal care services. If combined with information on women’s and care providers’ needs, this can contribute to ensuring continuation of essential care provision during emergency.

Introduction Pregnancy in sickle cell disease is fraught with many complications including pre-eclampsia (PE) and intrauterine growth restriction (IUGR). Previously, we found an abnormality in prostacyclin–thromboxane ratio in sickle cell pregnant women, a situation that is also found in non-sickle pregnancies with PE and unexplained IUGR. Low-dose aspirin (LDA) has been shown to reduce the incidence of PE and IUGR in high-risk women by reducing the vasoconstrictor thromboxane while sparing prostacyclin, in effect ‘correcting’ the ratio. It has been found to be safe for use in pregnancy but has not been tested in sickle cell pregnancy. We hypothesise that LDA will reduce the incidence of IUGR and PE in pregnant haemoglobin SS (HbSS) and haemoglobin SC (HbSC) women.Methods and analysis This is a multisite, double blind, randomised controlled trial, comparing a daily dose of 100 mg aspirin to placebo, from 12 to 16 weeks’ gestation until 36 weeks, in Lagos state, Nigeria. Four hundred and seventy-six eligible pregnant HbSS and HbSC women will be recruited consecutively, randomly assigned to either group and followed from recruitment until delivery. The primary outcome will be the incidence of birth weight below 10th centile for gestational age on INTERGROWTH 21 birth weight charts, or incidence of miscarriage or perinatal death. Secondary outcomes will include PE, maternal death, preterm delivery, perinatal death, number of crises, need for blood transfusion and complications such as infections and placental abruption. Analysis will be by intention to treat and the main treatment effects will be quantified by relative risk with 95% CI, at a 5% significance level.Ethical approval Ethical approval has been granted by the Health Research and Ethics committees of the recruiting hospitals and the National Health Research and Ethics Committee. Study findings will be presented at conferences and published appropriately.Trail registration number PACTR202001787519553; Pre-results.

Introduction: Sickle cell disease in pregnancy carries increased risk of maternal and perinatal morbidity and mortality. Past studies on pregnancy complications in sickle cell disease women were limited by relatively small sample sizes, and use of retrospective and hospital discharge data. Study Design: This prospective case-control study compared booked pregnant Haemoglobin (Hb) SS women with AA controls from two tertiary centres in Lagos, in order to precisely identify their complication and mortality rates and identify associated factors. Eligible pregnant HbSS and HbAA women were recruited from antenatal clinics at booking and follow-up visits. Information was collected on a proforma and data was analyzed using IBM SPSS version 20. Results: We found higher complication rate in HbSS group, commonest complications being vaso-occlusive crisis (RR 1.47, 95% CI 1.22 – 1.78), pregnancy induced hypertension (RR 1.31, 95% CI 1.08 – 1.57), urinary tract infection (RR 1.32, 95% CI 1.12 – 1.57), and intrauterine growth restriction (RR 1.2, 95% CI 1.05 – 1.34). HbSS group had higher systolic and mean arterial blood pressure values in early puerperium compared to HbAA group (p = 0.014 and 0.024 respectively). No maternal death recorded in both group. Incidence of low birth weight

INTRODUCTION: Genetic diseases and congenital anomalies place a significant burden on the health of new-borns and their mothers. Despite the availability of a variety of prenatal screening tests, mothers´ knowledge has been documented to determine uptake. This study aims to assess the knowledge of pregnant women about birth defects and the associated correlates with regard to willingness to do prenatal screening. METHODS: a cross-sectional descriptive study was conducted among 422 antenatal mothers, recruited sequentially as they attended antenatal clinic at the Lagos University Teaching Hospital. An interviewer-administered questionnaire was used to determine their knowledge of congenital birth defects and willingness to do prenatal testing. RESULTS: majority of the participants (92.2%) had at least secondary education. The mean total knowledge score of the respondents was 63%. Age and knowledge scores were not significantly correlated (r=-0.071, p=0.14). Being employed predicted higher knowledge scores (95% CI: 0.09, 2.09, p=0.03). Respondents who had primary school education and those who replied "I don´t know" to willingness to test had significantly lower knowledge scores (95% CI:-15.01, -1.19, p=0.02 and 95% CI:-4.52, -0.68, p=0.01 respectively). Majority (79.1%) of the respondents were willing to undergo testing. Respondents´ level of education was significantly associated with willingness to test (p=0.03). CONCLUSION: the observed knowledge gaps were considerable. There is need for improvement in education, the empowerment of women and access to quality healthcare including prenatal screening.

Objective: The aim of this study was to evaluate foeto-placental (F/P) parameters, namely foetal birth weight, placental weight (PW) and F/P weight ratio, in normal pregnancy and factors affecting them. Methodology: A retrospective study was conducted on labour ward data obtained over a period of 3 years (2015–2017). Only deliveries above 28-week gestational age which met other selection criteria were included in the study. Their sociodemographic parameters, PW, foetal birth weight, foetal outcome and Apgar scores were extracted from the delivery registers. The F/P weight ratio was calculated from the values obtained. All data collected were subjected to statistical analysis using SPSS version 20. Results: The mean age ± standard error of mean of parturient was 31.84 ± 0.18 years. A larger proportion, 1455 (80.7%) of the women were booked. The mean gestational age ± standard deviation at delivery was 37.81 ± 2.72 weeks. Foetal weight (FW), PW and F/P weight ratio rise progressively with advancing gestational age in normal pregnancy, the FW rising faster than the placenta which gains weight slowly. The F/P ratio rises steadily initially and then abruptly from 42-week gestational age as the foetus outgrows the placenta, after which there is a sharp decline from 43-week gestational age. FW, PW and F/P ratio are significantly affected by gestational age and booking status (P = 0.000). Parity and foetal sex were found to have significant influence on FW alone (P = 0.026 and P = 0.000, respectively). Conclusion: This study clarifies the need to avoid undue prolongation of pregnancy beyond 42 weeks to avert adverse consequences which may be related to the differential growth in the foetus and placenta.

Introduction Postpartum anaemia is often caused by iron deficiency with onset during the antepartum period and can be exacerbated by excessive blood loss at birth. Its prevalence is estimated as 50–80% in low-income and middle-income countries. It poses adverse consequences on the mother and negatively impacts her ability to care for her newborn. Prompt treatment of postpartum anaemia is thus important. Adherence to oral iron is reportedly low in Nigeria due to its side effects and forgetfulness by the mothers. Intravenous iron such as ferric carboxymaltose, given as a single dose, might help overcome adherence issues, but investigation in a high-quality randomised control trial in Nigeria is first required while evaluation of challenges around its implementation is also warranted.Objective To determine the clinical effectiveness, tolerability and safety, of using intravenous ferric carboxymaltose (intervention) vs oral ferrous sulphate (control) for treating moderate to severe iron deficiency anaemia in postpartum women and to evaluate implementation of ferric carboxymaltose in treating postpartum anaemia in Nigeria.Methods and analysis This study is an open-label randomised controlled trial with a concurrent implementation study. It is a hybrid type 1 effectiveness-implementation design conducted in four states across Northern and Southern Nigeria. A total of 1400 eligible and consenting women with postpartum moderate to severe anaemia (haemoglobin concentration

Abstract 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

Abstract Objective To determine if genetic polymorphism of VEGF is associated with the development of endometriosis in Nigerian women. Study design Case control study of 100 women (50 healthy controls and 50 with endometriosis). Serum VEGF concentration of participants were determined using enzyme-linked immunosorbent assay (ELISA) technique. Genomic DNAs were isolated from peripheral blood samples and quantified by nanodrop spectrophotometer one. Single nucleotide polymorphisms genotyping was carried out by polymerase chain reaction and restriction fragment length polymorphism (PCR–RFLP). Results Mean age of participants was 32.96 ± 6.91 years for control and 32.04 ± 7.56 years for cases. VEGF levels in case and control groups were not statistically different (82.68 pg/ml [69.11–121.11 pg/ml] vs. 82.81 pg/ml [72.90–113.82 pg/ml] respectively; p = 0.967). All four genotypes examined were in Hardy–Weinberg equilibrium. Minor allele frequency of − 460T > C, − 1154G > A, + 936C > T and + 2578C > A were 24%, 8%, 6% and 10% in the control and 19%, 9%, 5% and 14% in endometriosis patients. However, allele and genotype distributions of − 460T > C, − 1154G > A, + 936C > T and + 2578C > A VEGF polymorphisms in endometriosis patients and control were not significantly different (p > 0.05). Conclusion Our preliminary findings revealed no association between endometriosis and − 460T > C, − 1154G > A, + 936C > T and + 2578C > A of VEGF genes among Nigerian women.