Place of delivery and perinatal mortality in Kenya.

BACKGROUND: Increasing access to skilled birth attendants is a key goal in reducing perinatal mortality. In Kenya, where 40% of births occur at home, efforts toward this goal have focused on providing free maternity services in government facilities and discouraging home births. PURPOSE: To identify trends in facility deliveries and determine the association between delivery location and PM in Kenya. METHODS: We utilized data on 36,375 deliveries from the Kenya site of the Global Network for Women's and Children's Health Research, which maintains a prospective, population-based observational study of pregnancy and neonatal outcomes. We identified temporal trends in facility utilization and perinatal mortality. We then assessed associations between delivery location and PM using generalized linear mixed equations. RESULTS: The percentage of facility births increased from 38.4% in 2009 to 47.6% in 2013, with no change in perinatal mortality. Infants delivered in a facility had a higher risk of perinatal mortality than infants delivered at home (aOR = 1.41, p = 0.005). In stratified analyses, hospital deliveries had a higher adjusted odds of perinatal mortality than home and health center deliveries, with no difference between health center and home deliveries. CONCLUSION: The increase in facility deliveries between 2009 and 2013 was not associated with a decline in perinatal mortality. Infants born in facilities had a 41% greater risk of perinatal mortality than infants born at home. Further research is needed to assess possible explanations for this finding, including delays in referring and caring for complicated pregnancies, higher risk infants delivering at facilities, and poor quality of care in facilities.

Trends of antenatal care during pregnancy in low- and middle-income countries: Findings from the global network maternal and newborn health registry.

BACKGROUND: Antenatal care (ANC) is an important opportunity to diagnose and treat pregnancy-related complications and to deliver interventions aimed at improving health and survival of both mother and the infant. Multiple individual studies and national surveys have assessed antenatal care utilization at a single point in time across different countries, but ANC trends have not often been studied in rural areas of low-middle income countries (LMICs). The objective of this analysis was to study the trends of antenatal care use in LMICs over a seven-year period. METHODS: Using a prospective maternal and newborn health registry study, we analyzed data collected from 2011 to 2017 across five countries (Guatemala, India [2 sites], Kenya, Pakistan, and Zambia). Utilization of any ANC along with use of select services, including vitamins/iron, tetanus toxoid vaccine and HIV testing, were assessed. We used a generalized linear regression model to examine the trends of women receiving at least one and at least four antenatal care visits by site and year, controlling for maternal age, education and parity. RESULTS: Between January 2011 and December 2017, 313,663 women were enrolled and included in the analysis. For all six sites, a high proportion of women received at least one ANC visit across this period. Over the years, there was a trend for an increasing proportion of women receiving at least one and at least four ANC visits in all sites, except for Guatemala where a decline in ANC was observed. Regarding utilization of specific services, in India almost 100% of women reported receiving tetanus toxoid vaccine, vitamins/iron supplementation and HIV testing services for all study years. In Kenya, a small increase in the proportion of women receiving tetanus toxoid vaccine was observed, while for Zambia, tetanus toxoid use declined from 97% in 2011 to 89% in 2017. No trends for tetanus toxoid use were observed for Pakistan and Guatemala. Across all countries an increasing trend was observed for use of vitamins/iron and HIV testing. However, HIV testing remained very low (<0.1%) for Pakistan. CONCLUSION: In a range of LMICs, from 2011 to 2017 nearly all women received at least one ANC visit, and a significant increase in the proportion of women who received at least four ANC visits was observed across all sites except Guatemala. Moreover, there were variations regarding the utilization of preventive care services across all sites except for India where rates were generally high. More research is required to understand the quality and influences of ANC.

Iron in Micronutrient Powder Promotes an Unfavorable Gut Microbiota in Kenyan Infants.

Iron supplementation may have adverse health effects in infants, probably through manipulation of the gut microbiome. Previous research in low-resource settings have focused primarily on anemic infants. This was a double blind, randomized, controlled trial of home fortification comparing multiple micronutrient powder (MNP) with and without iron. Six-month-old, non- or mildly anemic, predominantly-breastfed Kenyan infants in a rural malaria-endemic area were randomized to consume: (1) MNP containing 12.5 mg iron (MNP+Fe, n = 13); (2) MNP containing no iron (MNP-Fe, n = 13); or (3) Placebo (CONTROL, n = 7), from 6-9 months of age. Fecal microbiota were profiled by high-throughput bacterial 16S rRNA gene sequencing. Markers of inflammation in serum and stool samples were also measured. At baseline, the most abundant phylum was Proteobacteria (37.6% of rRNA sequences). The proteobacterial genus Escherichia was the most abundant genus across all phyla (30.1% of sequences). At the end of the intervention, the relative abundance of Escherichia significantly decreased in MNP-Fe (-16.05 ± 6.9%, p = 0.05) and CONTROL (-19.75 ± 4.5%, p = 0.01), but not in the MNP+Fe group (-6.23 ± 9%, p = 0.41). The second most abundant genus at baseline was Bifidobacterium (17.3%), the relative abundance of which significantly decreased in MNP+Fe (-6.38 ± 2.5%, p = 0.02) and CONTROL (-8.05 ± 1.46%, p = 0.01), but not in MNP-Fe (-4.27 ± 5%, p = 0.4445). Clostridium increased in MNP-Fe only (1.9 ± 0.5%, p = 0.02). No significant differences were observed in inflammation markers, except for IL-8, which decreased in CONTROL. MNP fortification over three months in non- or mildly anemic Kenyan infants can potentially alter the gut microbiome. Consistent with previous research, addition of iron to the MNP may adversely affect the colonization of potential beneficial microbes and attenuate the decrease of potential pathogens.

Helping Babies Breathe (HBB) training: What happens to knowledge and skills over time?

BACKGROUND: The first minutes after birth are critical to reducing neonatal mortality. Helping Babies Breathe (HBB) is a simulation-based neonatal resuscitation program for low resource settings. We studied the impact of initial HBB training followed by refresher training on the knowledge and skills of the birth attendants in facilities. METHODS: We conducted HBB trainings in 71 facilities in the NICHD Global Network research sites (Nagpur and Belgaum, India and Eldoret, Kenya), with a 6:1 ratio of facility trainees to Master Trainers (MT). Because of staff turnover, some birth attendants (BA) were trained as they joined the delivery room staff, after the initial training was completed (catch-up initial training). We compared pass rates for skills and knowledge pre- and post- initial HBB training and following refresher training among active BAs. An Objective Structured Clinical Examination (OSCE) B tested resuscitation skill retention by comparing post-initial training performance with pre-refresher training performance. We identified factors associated with loss of skills in pre-refresher training performance using multivariable logistic regression analysis. Daily bag and mask ventilation practice, equipment checks and supportive supervision were stressed as part of training. RESULTS: One hundred five MT (1.6 MT per facility) conducted initial and refresher HBB trainings for 835 BAs; 76% had no prior resuscitation training. Initial training improved knowledge and skills: the pass percentage for knowledge tests improved from 74 to 99% (p < 0.001). Only 5% could ventilate a newborn mannequin correctly before initial training but 97% passed the post-initial ventilation training test (p < 0.0001) and 99% passed the OSCE B resuscitation evaluation. During pre-refresher training evaluation, a mean of 6.7 (SD 2.49) months after the initial training, 99% passed the knowledge test, but the successful completion rate fell to 81% for the OSCE B resuscitation skills test. Characteristics associated with deterioration of resuscitation skills were BAs from tertiary care facilities, no prior resuscitation training, and the timing of training (initial vs. catch-up training). CONCLUSIONS: HBB training significantly improved neonatal resuscitation knowledge and skills. However, skills declined more than knowledge over time. Ongoing skills practice and monitoring, more frequent retesting, and refresher trainings are needed to maintain neonatal resuscitation skills. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01681017 ; 04 September 2012, retrospectively registered.

Self-reported practices among traditional birth attendants surveyed in western Kenya: a descriptive study.

BACKGROUND: The high rate of home deliveries conducted by unskilled birth attendants in resource-limited settings is an important global health issue because it is believed to be a significant contributing factor to maternal and newborn mortality. Given the large number of deliveries that are managed by unskilled or traditional birth attendants outside of health facilities, and the fact that there is on-going discussion regarding the role of traditional birth attendants in the maternal newborn health (MNH) service continuum, we sought to ascertain the practices of traditional birth attendants in our catchment area. The findings of this descriptive study might help inform conversations regarding the roles that traditional birth attendants can play in maternal-newborn health care. METHODS: A structured questionnaire was used in a survey that included one hundred unskilled birth attendants in western Kenya. Descriptive statistics were employed. RESULTS: Inappropriate or outdated practices were reported in relation to some obstetric complications and newborn care. Encouraging results were reported with regard to positive relationships that traditional birth attendants have with their local health facilities. Furthermore, high rates of referral to health facilities was reported for many common obstetric emergencies and similar rates for reporting of pregnancy outcomes to village elders and chiefs. CONCLUSIONS: Potentially harmful or outdated practices with regard to maternal and newborn care among traditional birth attendants in western Kenya were revealed by this study. There were high rates of traditional birth attendant referrals of pregnant mothers with obstetric complications to health facilities. Policy makers may consider re-educating and re-defining the roles and responsibilities of traditional birth attendants in maternal and neonatal health care based on the findings of this survey.

Zinc absorption from micronutrient powder is low but is not affected by iron in Kenyan infants.

Interference with zinc absorption is a proposed explanation for adverse effects of supplemental iron in iron-replete children in malaria endemic settings. We examined the effects of iron in micronutrient powder (MNP) on zinc absorption after three months of home fortification with MNP in maize-based diets in rural Kenyan infants. In a double blind design, six-month-old, non-anemic infants were randomized to MNP containing 5 mg zinc, with or without 12.5 mg of iron (MNP + Fe and MNP − Fe, respectively); a control (C) group received placebo powder. After three months, duplicate diet collections and zinc stable isotopes were used to measure intake from MNP + non-breast milk foods and fractional absorption of zinc (FAZ) by dual isotope ratio method; total absorbed zinc (TAZ, mg/day) was calculated from intake × FAZ. Mean (SEM) TAZ was not different between MNP + Fe (n = 10) and MNP - Fe (n = 9) groups: 0.85 (0.22) and 0.72 (0.19), respectively, but both were higher than C (n = 9): 0.24 (0.03) (p = 0.04). Iron in MNP did not significantly alter zinc absorption, but despite intakes over double estimated dietary requirement, both MNP groups' mean TAZ barely approximated the physiologic requirement for age. Impaired zinc absorption may dictate need for higher zinc doses in vulnerable populations.

Implementation and evaluation of the Helping Babies Breathe curriculum in three resource limited settings: does Helping Babies Breathe save lives? A study protocol.

BACKGROUND: Neonatal deaths account for over 40% of all under-5 year deaths; their reduction is increasingly critical for achieving Millennium Development Goal 4. An estimated 3 million newborns die annually during their first month of life; half of these deaths occur during delivery or within 24 hours. Every year, 6 million babies require help to breathe immediately after birth. Resuscitation training to help babies breathe and prevent/manage birth asphyxia is not routine in low-middle income facility settings. Helping Babies Breathe (HBB), a simulation-training program for babies wherever they are born, was developed for use in low-middle income countries. We evaluated whether HBB training of facility birth attendants reduces perinatal mortality in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's Global Network research sites. METHODS/DESIGN: We hypothesize that a two-year prospective pre-post study to evaluate the impact of a facility-based training package, including HBB and essential newborn care, will reduce all perinatal mortality (fresh stillbirth or neonatal death prior to 7 days) among the Global Network's Maternal Neonatal Health Registry births ≥1500 grams in the study clusters served by the facilities. We will also evaluate the effectiveness of the HBB training program changing on facility-based perinatal mortality and resuscitation practices. Seventy-one health facilities serving 52 geographically-defined study clusters in Belgaum and Nagpur, India, and Eldoret, Kenya, and 30,000 women will be included. Primary outcome data will be collected by staff not involved in the HBB intervention. Additional data on resuscitations, resuscitation debriefings, death audits, quality monitoring and improvement will be collected. HBB training will include training of MTs, facility level birth attendants, and quality monitoring and improvement activities. DISCUSSION: Our study will evaluate the effect of a HBB/ENC training and quality monitoring and improvement package on perinatal mortality using a large multicenter design and approach in 71 resource-limited health facilities, leveraging an existing birth registry to provide neonatal outcomes through day 7. The study will provide the evidence base, lessons learned, and best practices that will be essential to guiding future policy and investment in neonatal resuscitation. TRIAL REGISTRATION: Trial registration ClinicalTrials.gov Identifier: NCT01681017.

First look: a cluster-randomized trial of ultrasound to improve pregnancy outcomes in low income country settings.

BACKGROUND: In high-resource settings, obstetric ultrasound is a standard component of prenatal care used to identify pregnancy complications and to establish an accurate gestational age in order to improve obstetric care. Whether or not ultrasound use will improve care and ultimately pregnancy outcomes in low-resource settings is unknown. METHODS/DESIGN: This multi-country cluster randomized trial will assess the impact of antenatal ultrasound screening performed by health care staff on a composite outcome consisting of maternal mortality and maternal near-miss, stillbirth and neonatal mortality in low-resource community settings. The trial will utilize an existing research infrastructure, the Global Network for Women's and Children's Health Research with sites in Pakistan, Kenya, Zambia, Democratic Republic of Congo and Guatemala. A maternal and newborn health registry in defined geographic areas which documents all pregnancies and their outcomes to 6 weeks post-delivery will provide population-based rates of maternal mortality and morbidity, stillbirth, neonatal mortality and morbidity, and health care utilization for study clusters. A total of 58 study clusters each with a health center and about 500 births per year will be randomized (29 intervention and 29 control). The intervention includes training of health workers (e.g., nurses, midwives, clinical officers) to perform ultrasound examinations during antenatal care, generally at 18-22 and at 32-36 weeks for each subject. Women who are identified as having a complication of pregnancy will be referred to a hospital for appropriate care. Finally, the intervention includes community sensitization activities to inform women and their families of the availability of ultrasound at the antenatal care clinic and training in emergency obstetric and neonatal care at referral facilities. DISCUSSION: In summary, our trial will evaluate whether introduction of ultrasound during antenatal care improves pregnancy outcomes in rural, low-resource settings. The intervention includes training for ultrasound-naïve providers in basic obstetric ultrasonography and then enabling these trainees to use ultrasound to screen for pregnancy complications in primary antenatal care clinics and to refer appropriately. TRIAL REGISTRATION: Clinicaltrials.gov (NCT # 01990625).

Home birth attendants in low income countries: who are they and what do they do?

BACKGROUND: Nearly half the world's babies are born at home. We sought to evaluate the training, knowledge, skills, and access to medical equipment and testing for home birth attendants across 7 international sites. METHODS: Face-to-face interviews were done by trained interviewers to assess level of training, knowledge and practices regarding care during the antenatal, intrapartum and postpartum periods. The survey was administered to a sample of birth attendants conducting home or out-of-facility deliveries in 7 sites in 6 countries (India, Pakistan, Guatemala, Democratic Republic of the Congo, Kenya and Zambia). RESULTS: A total of 1226 home birth attendants were surveyed. Less than half the birth attendants were literate. Eighty percent had one month or less of formal training. Most home birth attendants did not have basic equipment (e.g., blood pressure apparatus, stethoscope, infant bag and mask manual resuscitator). Reporting of births and maternal and neonatal deaths to government agencies was low. Indian auxilliary nurse midwives, who perform some home but mainly clinic births, were far better trained and differed in many characteristics from the birth attendants who only performed deliveries at home. CONCLUSIONS: Home birth attendants in low-income countries were often illiterate, could not read numbers and had little formal training. Most had few of the skills or access to tests, medications and equipment that are necessary to reduce maternal, fetal or neonatal mortality.

Impact of early and high amino acid supplementation on ELBW infants at 2 years.

OBJECTIVE: The aim of the present study was to examine the effects of early and high intravenous (IV) amino acid (AA) supplementation on growth, health, and neurodevelopment of extremely-low-birth-weight (ELBW) infants throughout their first 2 years of life. METHODS: Infants were prospectively randomized in a double-masked fashion and treated for 7 days with either IV AA starting at 0.5 g · kg (-1) · day(-1) and increased by 0.5 g · kg(-1) every day to 3 g · kg(-1)· day(-) or starting at 2 g · kg (-1) · day(-1) of IV AA and advanced by 1 g · kg(-1) every day to 4 g · kg (-1) · day(-1). Plasma AA concentrations were determined by reverse-phase high-performance liquid chromatography. Survivors were longitudinally assessed with Bayley II Scales of Infant Development and physical, social, and global health. RESULTS: Forty-three of 51 survivors were studied. Mental Developmental Index (MDI) and Psychomotor Developmental Index were similar between groups; however, the early and high AA group had a lower MDI at 18 months. This difference disappeared at 2 years of age. The early and high AA group z score means for weight, length, and head circumferences were significantly lower than the standard AA group at most visits. Cumulative and single plasma AA concentrations correlated negatively with MDI and postnatal growth. CONCLUSIONS: ELBW infants who received early and high IV AA during the first week of life were associated with poor overall growth at 2 years.

Epidemiology of stillbirth in low-middle income countries: a Global Network Study.

OBJECTIVE: To determine population-based stillbirth rates and to determine whether the timing and maturity of the stillbirths suggest a high proportion of potentially preventable deaths. DESIGN: Prospective observational study. SETTING: Communities in six low-income countries (Democratic Republic of Congo, Kenya, Zambia, Guatemala, India, and Pakistan) and one site in a mid-income country (Argentina). POPULATION: Pregnant women residing in the study communities. METHODS: Over a five-year period, in selected catchment areas, using multiple methodologies, trained study staff obtained pregnancy outcomes on each delivery in their area. MAIN OUTCOME MEASURES: Pregnancy outcome, stillbirth characteristics. RESULTS: Outcomes of 195,400 deliveries were included. Stillbirth rates ranged from 32 per 1,000 in Pakistan to 8 per 1,000 births in Argentina. Three-fourths (76%) of stillbirth offspring were not macerated, 63% were ≥ 37 weeks and 48% weighed 2,500 g or more. Across all sites, women with no education, of high and low parity, of older age, and without access to antenatal care were at significantly greater risk for stillbirth (p<0.001). Compared to those delivered by a physician, women delivered by nurses and traditional birth attendants had a lower risk of stillbirth. CONCLUSIONS: In these low-middle income countries, most stillbirth offspring were not macerated, were reported as ≥ 37 weeks' gestation, and almost half weighed at least 2,500 g. With access to better medical care, especially in the intrapartum period, many of these stillbirths could likely be prevented.

Early changes in plasma amino acid concentrations during aggressive nutritional therapy in extremely low birth weight infants.

OBJECTIVE: To examine the changes in plasma amino acid (AA) concentrations over time when extremely low birth weight infants are provided either a standard intravenous AA supplementation (standard AA) or an early and high supplementation regimen (early and high AA). STUDY DESIGN: Sixty-two infants were enrolled at birth in a randomized, double-masked, prospective fashion and treated for 7 days. The infants with standard AA concentrations received intravenous AA starting at 0.5 g/kg/d and increased by 0.5 g/kg every day to a maximum of 3 g/kg/d. Infants in the early and high AA group received 2 g/kg/d of intravenous AA soon after birth and advanced by 1 g/kg every day to 4 g/kg/d. Plasma AA concentrations were determined by high-pressure liquid chromatography on days 1, 3, and 7. RESULTS: Total AA concentrations, total essential AA concentrations, and total nonessential AA concentrations were significantly higher in the infants in the early and high AA group; essential AA concentrations and total AA concentrations were higher at 1 and 3 days, and nonessential AA concentrations were different only on day 3. There were significant differences between standard AA and early and high AA groups for all AA concentrations except the nonessential AAs Glu, Asn, Gly, Gln, Ala, and Tyr and the conditionally essential AA Cys. CONCLUSION: Infants who received early and higher parenteral AA had higher plasma AA concentrations.

Communities, birth attendants and health facilities: a continuum of emergency maternal and newborn care (the Global Network's EmONC trial).

BACKGROUND: Maternal and newborn mortality rates remain unacceptably high, especially where the majority of births occur in home settings or in facilities with inadequate resources. The introduction of emergency obstetric and newborn care services has been proposed by several organizations in order to improve pregnancy outcomes. However, the effectiveness of emergency obstetric and neonatal care services has never been proven. Also unproven is the effectiveness of community mobilization and community birth attendant training to improve pregnancy outcomes. METHODS/DESIGN: We have developed a cluster-randomized controlled trial to evaluate the impact of a comprehensive intervention of community mobilization, birth attendant training and improvement of quality of care in health facilities on perinatal mortality in low and middle-income countries where the majority of births take place in homes or first level care facilities. This trial will take place in 106 clusters (300-500 deliveries per year each) across 7 sites of the Global Network for Women's and Children's Health Research in Argentina, Guatemala, India, Kenya, Pakistan and Zambia. The trial intervention has three key elements, community mobilization, home-based life saving skills for communities and birth attendants, and training of providers at obstetric facilities to improve quality of care. The primary outcome of the trial is perinatal mortality. Secondary outcomes include rates of stillbirth, 7-day neonatal mortality, maternal death or severe morbidity (including obstetric fistula, eclampsia and obstetrical sepsis) and 28-day neonatal mortality. DISCUSSION: In this trial, we are evaluating a combination of interventions including community mobilization and facility training in an attempt to improve pregnancy outcomes. If successful, the results of this trial will provide important information for policy makers and clinicians as they attempt to improve delivery services for pregnant women and newborns in low-income countries. TRIAL REGISTRATION: ClinicalTrials.gov NCT01073488.