Burden and outcomes of postpartum haemorrhage in Nigerian referral-level hospitals.

OBJECTIVE: To determine the prevalence of primary postpartum haemorrhage (PPH), risk factors, and maternal and neonatal outcomes in a multicentre study across Nigeria. DESIGN: A secondary data analysis using a cross-sectional design. SETTING: Referral-level hospitals (48 public and six private facilities). POPULATION: Women admitted for birth between 1 September 2019 and 31 August 2020. METHODS: Data collected over a 1-year period from the Maternal and Perinatal Database for Quality, Equity and Dignity programme in Nigeria were analysed, stratified by mode of delivery (vaginal or caesarean), using a mixed-effects logistic regression model. MAIN OUTCOME MEASURES: Prevalence of PPH and maternal and neonatal outcomes. RESULTS: Of 68 754 women, 2169 (3.2%, 95% CI 3.07%-3.30%) had PPH, with a prevalence of 2.7% (95% CI 2.55%-2.85%) and 4.0% (95% CI 3.75%-4.25%) for vaginal and caesarean deliveries, respectively. Factors associated with PPH following vaginal delivery were: no formal education (aOR 2.2, 95% CI 1.8-2.6, P < 0.001); multiple pregnancy (aOR 2.7, 95% CI 2.1-3.5, P < 0.001); and antepartum haemorrhage (aOR 11.7, 95% CI 9.4-14.7, P < 0.001). Factors associated with PPH in a caesarean delivery were: maternal age of >35 years (aOR 1.7, 95% CI 1.5-2.0, P < 0.001); referral from informal setting (aOR 2.4, 95% CI 1.4-4.0, P = 0.002); and antepartum haemorrhage (aOR 3.7, 95% CI 2.8-4.7, P < 0.001). Maternal mortality occurred in 4.8% (104/2169) of deliveries overall, and in 8.5% (101/1182) of intensive care unit admissions. One-quarter of all infants were stillborn (570/2307), representing 23.9% (429/1796) of neonatal intensive care unit admissions. CONCLUSIONS: A PPH prevalence of 3.2% can be reduced with improved access to skilled birth attendants.

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.

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.

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.

Foeto-placental parameters in normal pregnancy and factors affecting them.

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.

Screening for bacterial vaginosis before intrauterine device insertion at a family planning clinic in south-west Nigeria.

AIM: This study determined the prevalence of bacterial vaginosis (BV) among clients before insertion of intrauterine device (IUD) and compared the incidence of complications between participants who were positive and negative for BV. PATIENTS AND METHODS: This was an observational cohort study that was performed between May 2014 and September 2014. A total of 360 women were recruited and followed up for 1 month. High vaginal swabs were obtained from each participant pre-insertion of the IUD and 1 month post-insertion. BV was diagnosed using Nugent's scoring. Data were collected, collated and analysed using frequency distributions and Chi-square test as appropriate. The level of statistical significance was P< 0.05. RESULTS: The prevalence of BV was 33.3%. The complication rate was 23.9% in which 30.5% complication rate was seen among participants positive for BV and 22.5% among participants negative for BV (P = 0.192). This was done with respect to four primary clinical outcomes. The incidence of BV one month after IUD insertion was 11.5%. CONCLUSION: The prevalence of BV was within the range reported in other populations. The complication rate appeared high; however, the differences in proportion between women positive and negative for BV were not statistically significant.

In-vitro fertilization, gamete donation and surrogacy: perceptions of women attending an infertility clinic in Ibadan, Nigeria.

Infertility affects 20% of couples in Nigeria. Assisted reproductive techniques (ART) offered in Nigeria include in-vitro fertilization (IVF), gamete donation and surrogacy. This cross-sectional questionnaire study aimed at assessing the acceptability of ART to women seeking infertility treatment at the University College Hospital, Ibadan, Nigeria. Of the 307 respondents, 58.3% were aware of IVF and 59.3% would accept it as treatment; 35.2% would accept donor eggs and 24.7% would accept donor sperms-a smaller proportion anticipated acceptability by their husbands. Thirty five percent were aware of surrogacy, 37.8% would accept it as treatment; most preferring a stranger as a surrogate. Most felt surrogates should not be paid. Acceptance of ART was associated with older age, longer duration of infertility, previous failed treatment and women without other children. As chances of successful pregnancy are improved in younger individuals, counselling towards overcome barriers to accepting gamete donation and surrogacy should be instituted early.

Serum Vitamin D Deficiency and Male Infertility: A Relationship?

Background Male infertility is one of the major reproductive health concerns, causing a lot of distress for couples globally. Others have looked into its connection to vitamin D deficiency, but their findings are conflicting. Aim This study aimed to determine the relationship between male infertility and vitamin D deficiency among Nigerians. Method This analytical cross-sectional study was conducted among 132 men. A purposive sampling technique was employed to recruit 66 participants in the study (men with infertility) and control groups (men with proven fertility). Descriptive statistics were conducted, while the association between vitamin D level and sperm parameters was assessed using bivariate and regression modeling. A two-tailed test of the hypothesis was assumed, and the level of statistical significance was set at a P-value < 0.05. Results None of the participants had a serum vitamin D deficiency. However, the overall serum vitamin D insufficiency rate was 15%. The median vitamin D level for the total study population (both fertile and infertile) was 37.52 ng/ml (IQR: 32.1 - 51.69). This study demonstrated no association between serum vitamin D levels and male infertility, as well as no association between serum vitamin D levels and the quality of semen parameters. Conclusion There was no significant association between vitamin D levels, male infertility, and seminal fluid parameters. However, larger multi-center studies are recommended to provide further insights into this conclusion.

A continuous quality improvement strategy to strengthen screening practices and facilitate the routine use of intravenous iron for treating anaemia in pregnant and postpartum women in Nigeria: a study protocol.

BACKGROUND: Pregnancy-related anaemia is a public health challenge across Africa. Over 50% of pregnant women in Africa get diagnosed with this condition, and up to 75% of these are caused by iron deficiency. The condition is a significant contributor to the high maternal deaths across the continent and, in particular, Nigeria, which accounts for about 34% of global maternal deaths. Whereas oral iron is the mainstay treatment for pregnancy-related anaemia in Nigeria, this treatment is not very effective given the slow absorption of the medication, and its gastrointestinal adverse effects which lead to poor compliance by women. Intravenous iron is an alternative therapy which can rapidly replenish iron stores, but fears of anaphylactic reactions, as well as several misconceptions, have inhibited its routine use. Newer and safer intravenous iron formulations, such as ferric carboxymaltose, present an opportunity to overcome some concerns relating to adherence. Routine use of this formulation will, however, require addressing misconceptions and systemic barriers to adoption in the continuum of care of obstetric women from screening to treatment. This study aims to test the options to strengthen routine screening for anaemia during and immediately after pregnancy, as well as evaluate and improve conditions necessary to deliver ferric carboxymaltose to pregnant and postpartum women with moderate to severe anaemia. METHODS: This study will be conducted in a cluster of six health facilities in Lagos State, Nigeria. The study will employ continuous quality improvement through the Diagnose-Intervene-Verify-Adjust framework and Tanahashi's model for health system evaluation to identify and improve systemic bottlenecks to the adoption and implementation of the intervention. Participatory Action Research will be employed to engage health system actors, health services users, and other stakeholders to facilitate change. Evaluation will be guided by the consolidated framework for implementation research and the normalisation process theory. DISCUSSION: We expect the study to evolve transferable knowledge on barriers and facilitators to the routine use of intravenous iron that will inform scale-up across Nigeria, as well as the adoption of the intervention and strategies in other countries across Africa.

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).

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.

Effects of selenium supplementation on pregnancy outcome and disease progression in HIV-infected pregnant women in Lagos, Nigeria: Study protocol for a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Micronutrient deficiencies are common during pregnancy, especially in pregnant women from economically disadvantaged settings where diets with low content of minerals and vitamins are consumed. Selenium is a non-metallic chemical element of great importance to human health. This study will assess the effect of selenium supplementation on major pregnancy outcomes and disease progression among HIV-infected pregnant women in Lagos, Nigeria. METHODS: A randomized, double-blind, placebo-controlled trial involving confirmed HIV-positive pregnant women at the Lagos University Teaching Hospital (LUTH) between September 2018 and February 2019. Eligible participants are HIV-infected pregnant women aged 15 to 49 years and have a singleton gestation at 14 to 27 weeks' gestation. At enrolment, 90 women will be randomly assigned into each intervention arm to receive either a daily tablet of 200 µg elemental selenium or placebo. Relevant participants' data will be collected at enrolment and at delivery. Statistical analyses will be carried out using SPSS version 23.0 for Windows. The associations between any 2 groups of continuous variables will be tested using the t test or the Mann-Whitney U test and that of 2 groups of categorical variables with chi-square or Fishers exact test where appropriate. A series of multivariable analyses will also be carried out to identify and control for several possible confounders of the major pregnancy outcomes and HIV disease progression. Statistical significance will be defined as P < .05. Ethical approval for the study was obtained from the LUTH's Health Research and Ethics Committee (Approval number: ADM/DCST/HREC/APP/2438; 30th August 2018). DISCUSSION: This trial will assess the effect of selenium supplementation on pregnancy outcome and HIV disease progression among HIV-infected pregnant women in Lagos. This will help to determine if routine selenium supplementation in HIV-infected pregnant women will contribute to the improvement in the major adverse pregnancy outcomes such as preterm birth and low birth weight and the HIV disease surrogate markers such as CD4+ cells count and viral load. TRIAL REGISTRATION: PACTR, PACTR201809756724274. Registered on 3rd September 2018, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3571.