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1. Sociodemographic, living environment and maternal health associations with stillbirth in a tertiary healthcare setting in Kano, Northern Nigeria

Author

Rebecca Milton, Fatima Modibbo, David Gillespie, Fatima Alkali, Aisha Mukaddas, Fatima Sa’ad, Fatima Tukur, Rashida Khalid, Maryam Yahaya Muhammad, Murjanatu Bello, Chinago Precious Edwin, Ese Ogudo, Kenneth Iregbu, Lim Jones, Kerenza Hood, Peter Ghazal, Julia Sanders, Brekhna Hassan, and Timothy Walsh

Subjects
Demography. Population. Vital events, HB848-3697
Abstract

Background Stillbirths are reported as one of the most neglected tragedies in global health, with around 2m stillbirths occurring annually and the majority occurring in low- and middle income countries (LMICs). Many antenatal stillbirths are due to preventable conditions such as maternal infections and non-communicable diseases. Almost half of all stillbirths occur during the intrapartum period, with many linked to obstetric complications. Known risk factors for stillbirths overall include young or advancing maternal age, fetal infection, maternal hypertensive conditions, perinatal asphyxia, history of previous stillbirth, obstetric complications, intrauterine growth restriction and abruptio placenta/placenta praevia. Common non-clinical risk factors include lack of education, socioeconomic deprivation and substandard antenatal care. Methods A single site prospective observational study conducted over three-months was conducted in a tertiary referral hospital in Kano, Nigeria. Eligible participants were mothers presenting at the site in labour and their babies. Demographic and clinical data were collected by paper-based questionnaires. Data were collected on living environment, health and medical history, pregnancy history and pregnancy/birth factors. Each mother answered pre-delivery questions, with potential follow-on questions dependent on birth outcome. Further data points were collected from clinical observations. Photographs were taken of stillborn babies to support data collected and to aid the UK team on classifying degrees of maceration in an attempt to identify antenatal and intrapartum fetal death. Findings Higher odds of stillbirth were associated with low levels of education, a further distance to travel from home to the hospital, living in a shack, maternal hypertension and having had a previous stillbirth after adjusting for all sociodemographic and health features. Higher odds of intrapartum stillbirth included; shoulder presentation, compound presentation and breech presentation compared to cephalic presentation. Other birth related factors associated with higher odds of stillbirth included reported birthing complications, duration of labour being >=18 hours), antepartum haemorrhage, prolonged/obstructed labour, vaginal breech delivery, emergency Caesarean-section delivery, and signs of trauma to the neonate. Conclusions Identified risk factors associated with stillbirths are relatively amenable to intervention and a lot of work has been conducted globally, so the development of intervention with sufficient funding should be a relatively rapid process. For collaborations please contact: Email: miltonrl1@cardiff.ac.uk

Published
2022
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2. Determinants of Stillbirth From Two Observational Studies Investigating Deliveries in Kano, Nigeria

Author

Rebecca Milton, Fatima Zara Modibbo, William John Watkins, David Gillespie, Fatima Ibrahim Alkali, Murjanatu Bello, Chinagozi Precious Edwin, Fatima Habib Sa ad, Kerenza Hood, Kenneth Iregbu, Aishatu Kassim, Rashida Yakubu Khalid, Maryam Yahaya Muhammad, Aisha Sani Mukaddas, Ese Ogudo, Fatima Muhammad Tukur, and Timothy Rutland Walsh

Subjects
stillbirth, stillborn, global health, neonatal, maternal, epidemiology, Gynecology and obstetrics, RG1-991, Women. Feminism, HQ1101-2030.7
Abstract

Background:Stillbirths are a poignant representation of global inequality. Nigeria is documented to have the second highest rate; yet, the reporting system is inadequate in most Nigerian healthcare facilities. The aim was to identify the determinants of stillbirth among deliveries in the Murtala Muhammad Specialist Hospital (MMSH), Kano, Nigeria.Methods:Two study designs were used: a case-control study (S1) and a prospective cohort study (S2). Both studies were carried out at the MMSH. For S1, stillbirths were retrospectively matched to a livebirth by time (target of 24 hours' time variation) to establish a case-control study with a 1:1 ratio. Eligibility into S2 included all mothers who were presented at the MMSH in labour regardless of birth outcome. Both were based on recruitment durations, not sample sizes (3 months and 2 months, respectively, 2017–2018). The demographic and clinical data were collected through paper-based questionnaires. Univariable logistic regression was used. Multivariable logistic regression was used to explore relationships between area type and other specific factors.Findings:Stillbirth incidence in S2 was 180/1,000 births. Stillbirth was associated with the following factors; no maternal education, previous stillbirth(s), prematurity, living in both semi-rural and rural settings, and having extended time periods between rupture of membranes and delivery. Findings of the multivariable analysis (S1 and S2) indicated that the odds of stillbirth, for those living in a rural area, were further exacerbated in those mothers who had no education, lived in a shack, or had any maternal disease.Interpretation:This research identifies the gravity of this situation in this area and highlights the need for action. Further understanding of some of the findings and exploration into associations are required to inform intervention development.Funding:This collaboration was partially supported by funding from Health and Care Research Wales.

Published
2022
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3. Neonatal sepsis and mortality in low-income and middle-income countries from a facility-based birth cohort: an international multisite prospective observational study

Author

Rebecca Milton, David Gillespie, Calie Dyer, Khadijeh Taiyari, Maria J Carvalho, Kathryn Thomson, Kirsty Sands, Edward A R Portal, Kerenza Hood, Ana Ferreira, Thomas Hender, Nigel Kirby, Jordan Mathias, Maria Nieto, William J Watkins, Delayehu Bekele, Mahlet Abayneh, Semaria Solomon, Sulagna Basu, Ranjan K Nandy, Bijan Saha, Kenneth Iregbu, Fatima Z Modibbo, Stella Uwaezuoke, Rabaab Zahra, Haider Shirazi, Syed U Najeeb, Jean-Baptiste Mazarati, Aniceth Rucogoza, Lucie Gaju, Shaheen Mehtar, Andre N H Bulabula, Andrew C Whitelaw, Timothy R Walsh, Grace J Chan, Oludare Odumade, Rozina Ambachew, Zenebe Gebre Yohannes, Gesit Metaferia, Redeat Workneh, Tefera Biteye, Yahya Zekaria Mohammed, Alula M Teklu, Balkachew Nigatu, Wendimagegn Gezahegn, Partha Sarathi Chakravorty, Sharmi Naha, Anuradha Mukherjee, Khairiyya Muhammad Umar, Asunugwo Vivian Akunna, Queen Nsude, Ifeoma Uke, Mary-Joe Okenu, Chinenye Akpulu, Chukwuemeka Mmadueke, Samuel Yakubu, Lamidi Audu, Nura Idris, Safiya Gambo, Jamila Ibrahim, Edwin Chinago, Ashiru Yusuf, Shamsudden Gwadabe, Adeola Adeleye, Muhammad Aliyu, Amina Muhammad, Aishatu Kassim, Aisha Sani Mukaddas, Rashida Yakubu Khalid, Fatima Ibrahim Alkali, Maryam Yahaya Muhammad, Fatima Muhammad Tukur, Surayya Mustapha Muhammad, Adeola Shittu, Murjanatu Bello, Fatima Habib Sa ad, Shaheed Zulfiqar, Adil Muhammad, Muhammad Hilal Jan, and Lauren Paterson

Subjects
Pregnancy, Sepsis, Infant Mortality, Infant, Newborn, Humans, Premature Birth, Female, General Medicine, Prospective Studies, Neonatal Sepsis, Developing Countries
Abstract

Background\udNeonatal sepsis is a primary cause of neonatal mortality and is an urgent global health concern, especially within low-income and middle-income countries (LMICs), where 99% of global neonatal mortality occurs. The aims of this study were to determine the incidence and associations with neonatal sepsis and all-cause mortality in facility-born neonates in LMICs.\udMethods\udThe Burden of Antibiotic Resistance in Neonates from Developing Societies (BARNARDS) study recruited mothers and their neonates into a prospective observational cohort study across 12 clinical sites from Bangladesh, Ethiopia, India, Pakistan, Nigeria, Rwanda, and South Africa. Data for sepsis-associated factors in the four domains of health care, maternal, birth and neonatal, and living environment were collected for all mothers and neonates enrolled. Primary outcomes were clinically suspected sepsis, laboratory-confirmed sepsis, and all-cause mortality in neonates during the first 60 days of life. Incidence proportion of livebirths for clinically suspected sepsis and laboratory-confirmed sepsis and incidence rate per 1000 neonate-days for all-cause mortality were calculated. Modified Poisson regression was used to investigate factors associated with neonatal sepsis and parametric survival models for factors associated with all-cause mortality.\udFindings\udBetween Nov 12, 2015 and Feb 1, 2018, 29 483 mothers and 30 557 neonates were enrolled. The incidence of clinically suspected sepsis was 166·0 (95% CI 97·69–234·24) per 1000 livebirths, laboratory-confirmed sepsis was 46·9 (19·04–74·79) per 1000 livebirths, and all-cause mortality was 0·83 (0·37–2·00) per 1000 neonate-days. Maternal hypertension, previous maternal hospitalisation within 12 months, average or higher monthly household income, ward size (>11 beds), ward type (neonatal), living in a rural environment, preterm birth, perinatal asphyxia, and multiple births were associated with an increased risk of clinically suspected sepsis, laboratory-confirmed sepsis, and all-cause mortality. The majority (881 [72·5%] of 1215) of laboratory-confirmed sepsis cases occurred within the first 3 days of life.\udInterpretation\udFindings from this study highlight the substantial proportion of neonates who develop neonatal sepsis, and the high mortality rates among neonates with sepsis in LMICs. More efficient and effective identification of neonatal sepsis is needed to target interventions to reduce its incidence and subsequent mortality in LMICs.\udFunding\udBill & Melinda Gates Foundation.

Published
2022

4. Effects of antibiotic resistance, drug target attainment, bacterial pathogenicity and virulence, and antibiotic access and affordability on outcomes in neonatal sepsis: an international microbiology and drug evaluation prospective substudy (BARNARDS)

Author

Kathryn M Thomson, Calie Dyer, Feiyan Liu, Kirsty Sands, Edward Portal, Maria J Carvalho, Matthew Barrell, Ian Boostrom, Susanna Dunachie, Refath Farzana, Ana Ferreira, Francis Frayne, Brekhna Hassan, Ellis Jones, Lim Jones, Jordan Mathias, Rebecca Milton, Jessica Rees, Grace J Chan, Delayehu Bekele, Abayneh Mahlet, Sulagna Basu, Ranjan K Nandy, Bijan Saha, Kenneth Iregbu, Fatima Modibbo, Stella Uwaezuoke, Rabaab Zahra, Haider Shirazi, Najeeb U Syed, Jean-Baptiste Mazarati, Aniceth Rucogoza, Lucie Gaju, Shaheen Mehtar, Andre N H Bulabula, Andrew Whitelaw, Johan G C van Hasselt, Timothy R Walsh, Samir Saha, Maksuda Islam, Zabed Bin-Ahmed, Wazir Ahmed, Taslima Begum, Mitu Chowdhury, Shaila Sharmin, Chumki Rani Dey, null Uttam, Abdul Matin, Sowmitra Ranjan Chakraborty, Sadia Tasmin, Dipa Rema, Rashida Khatun, Liza Nath, Nigatu Balkachew, Katherine Schaughency, Semaria Solomon, Zenebe Gebreyohanes, Rozina Ambachew, Oludare Odumade, Misgana Haileselassie, Grace Chan, Abigail Russo, Redeat Workneh, Gesit Metaferia, Mahlet Abayneh, Yahya Zekaria Mohammed, Tefera Biteye, Alula Teklu, Wendimagegn Gezahegn, Partha Sarathi Chakravorty, Anuradha Mukherjee, Ranjan Kumar Nandy, Samarpan Roy, Anuradha Sinha, Sharmi Naha, Sukla Saha Malakar, Siddhartha Bose, Monaki Majhi, Subhasree Sahoo, Putul Mukherjee, Sumitra Kumari Routa, Chaitali Nandi, Pinaki Chattopadhyay, Fatima Zara Isa Modibbo, Dilichukwu Meduekwe, Khairiyya Muhammad, Queen Nsude, Ifeoma Ukeh, Mary-Joe Okenu, Akpulu Chinenye, Samuel Yakubu, Vivian Asunugwo, Folake Aina, Isibong Issy, Dolapo Adekeye, Adiele Eunice, Abdulmlik Amina, R Oyewole, I Oloton, BC Nnaji, M Umejiego, PN Anoke, S Adebayo, GO Abegunrin, OB Omotosho, R Ibrahim, B Igwe, M Abroko, K Balami, L Bayem, C Anyanwu, H Haruna, J Okike, K Goroh, M Boi-Sunday, Augusta Ugafor, Maryam Makama, Kaniba Ndukwe, Anastesia Odama, Hadiza Yusuf, Patience Wachukwu, Kachalla Yahaya, Titus Kalade Colsons, Mercy Kura, Damilola Orebiyi, Kenneth C. Iregbu, Chukwuemeka Mmadueke, Lamidi Audu, Nura Idris, Safiya Gambo, Jamila Ibrahim, Edwin Precious, Ashiru Hassan, Shamsudden Gwadabe, Adeola Adeleye Falola, Muhammad Aliyu, Amina Ibrahim, Aisha Sani Mukaddas, Rashida Yakubu Khalid, Fatima Ibrahim Alkali, Maryam Yahaya Muhammad, Fatima Mohammad Tukur, Surayya Mustapha Muhammad, Adeola Shittu, Murjanatu Bello, Muhammad Abubakar Hassan, Fatima Habib Sa ad, Aishatu Kassim, Adil Muhammad, Syed Najeeb Ullah, Muhammad Hilal Jan, Rubina Kamran, null Sajana, Jazba Saeed, Noreen Maqsood, Maria Zafar, Saraeen Sadiq, Sumble Ahsan, Madiha Tariq, Sidra Sajid, Hasma Mustafa, Anees-ur Rehman, Atif Muhammad, Gahssan Mehmood, Mahnoor Nisar, Shermeen Akif, Tahira Yasmeen, Sabir Nawaz, Anam Shanal Atta, Mian Laiq-ur-Rehman, Robina Kousar, Kalsoom Bibi, Kosar Waheed, Zainab Majeed, Ayesha Jalil, Espoir Kajibwami, Innocent Nzabahimana, Mazarati Jean-Baptiste, Kankundiye Riziki, Brigette Uwamahoro, Rachel Uwera, Eugenie Nyiratuza, Kumwami Muzungu, Violette Uwitonze, Marie C Horanimpundu, Francine Nzeyimana, Prince Mitima, Angela Dramowski, Lauren Paterson, Mary Frans, Marvina Johnson, Eveline Swanepoel, Zoleka Bojana, Mieme du Preez, Andre Bulabula, Johan GC van Hasselt, Timothy Walsh, Maria Carvalho, Kathryn Thomson, Robert Andrews, John Watkins, David Gillespie, Kerry Hood, Katie Taiyai, Nigel Kirby, Maria Nieto, Thomas Hender, Patrick Hogan, Habiba Saif, Brad Spiller, Julian Parkhill, Apollo - University of Cambridge Repository, and Group, BARNARDS

Subjects
medicine.medical_specialty, Staphylococcus aureus, medicine.drug_class, Antibiotics, Sepsis, Cohort Studies, Antibiotic resistance, Enterobacteriaceae, Internal medicine, medicine, Humans, Developing Countries, Poverty, Neonatal sepsis, Virulence, business.industry, Enterobacteriaceae Infections, Infant, Newborn, Drug Resistance, Microbial, Articles, Amoxicillin, Staphylococcal Infections, medicine.disease, Anti-Bacterial Agents, Infectious Diseases, Amikacin, Colistin, Gentamicin, Drug Therapy, Combination, Neonatal Sepsis, business, medicine.drug
Abstract

Background Sepsis is a major contributor to neonatal mortality, particularly in low-income and middle-income countries (LMICs). WHO advocates ampicillin–gentamicin as first-line therapy for the management of neonatal sepsis. In the BARNARDS observational cohort study of neonatal sepsis and antimicrobial resistance in LMICs, common sepsis pathogens were characterised via whole genome sequencing (WGS) and antimicrobial resistance profiles. In this substudy of BARNARDS, we aimed to assess the use and efficacy of empirical antibiotic therapies commonly used in LMICs for neonatal sepsis. Methods In BARNARDS, consenting mother–neonates aged 0–60 days dyads were enrolled on delivery or neonatal presentation with suspected sepsis at 12 BARNARDS clinical sites in Bangladesh, Ethiopia, India, Pakistan, Nigeria, Rwanda, and South Africa. Stillborn babies were excluded from the study. Blood samples were collected from neonates presenting with clinical signs of sepsis, and WGS and minimum inhibitory concentrations for antibiotic treatment were determined for bacterial isolates from culture-confirmed sepsis. Neonatal outcome data were collected following enrolment until 60 days of life. Antibiotic usage and neonatal outcome data were assessed. Survival analyses were adjusted to take into account potential clinical confounding variables related to the birth and pathogen. Additionally, resistance profiles, pharmacokinetic–pharmacodynamic probability of target attainment, and frequency of resistance (ie, resistance defined by in-vitro growth of isolates when challenged by antibiotics) were assessed. Questionnaires on health structures and antibiotic costs evaluated accessibility and affordability. Findings Between Nov 12, 2015, and Feb 1, 2018, 36 285 neonates were enrolled into the main BARNARDS study, of whom 9874 had clinically diagnosed sepsis and 5749 had available antibiotic data. The four most commonly prescribed antibiotic combinations given to 4451 neonates (77·42%) of 5749 were ampicillin–gentamicin, ceftazidime–amikacin, piperacillin–tazobactam–amikacin, and amoxicillin clavulanate–amikacin. This dataset assessed 476 prescriptions for 442 neonates treated with one of these antibiotic combinations with WGS data (all BARNARDS countries were represented in this subset except India). Multiple pathogens were isolated, totalling 457 isolates. Reported mortality was lower for neonates treated with ceftazidime–amikacin than for neonates treated with ampicillin–gentamicin (hazard ratio [adjusted for clinical variables considered potential confounders to outcomes] 0·32, 95% CI 0·14–0·72; p=0·0060). Of 390 Gram-negative isolates, 379 (97·2%) were resistant to ampicillin and 274 (70·3%) were resistant to gentamicin. Susceptibility of Gram-negative isolates to at least one antibiotic in a treatment combination was noted in 111 (28·5%) to ampicillin–gentamicin; 286 (73·3%) to amoxicillin clavulanate–amikacin; 301 (77·2%) to ceftazidime–amikacin; and 312 (80·0%) to piperacillin–tazobactam–amikacin. A probability of target attainment of 80% or more was noted in 26 neonates (33·7% [SD 0·59]) of 78 with ampicillin–gentamicin; 15 (68·0% [3·84]) of 27 with amoxicillin clavulanate–amikacin; 93 (92·7% [0·24]) of 109 with ceftazidime–amikacin; and 70 (85·3% [0·47]) of 76 with piperacillin–tazobactam–amikacin. However, antibiotic and country effects could not be distinguished. Frequency of resistance was recorded most frequently with fosfomycin (in 78 isolates [68·4%] of 114), followed by colistin (55 isolates [57·3%] of 96), and gentamicin (62 isolates [53·0%] of 117). Sites in six of the seven countries (excluding South Africa) stated that the cost of antibiotics would influence treatment of neonatal sepsis. Interpretation Our data raise questions about the empirical use of combined ampicillin–gentamicin for neonatal sepsis in LMICs because of its high resistance and high rates of frequency of resistance and low probability of target attainment. Accessibility and affordability need to be considered when advocating antibiotic treatments with variance in economic health structures across LMICs. Funding The Bill & Melinda Gates Foundation.

Published
2020

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