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Strengthening intrapartum and immediate newborn care to reduce morbidity and mortality of preterm infants born in health facilities in Migori County, Kenya and Busoga Region, Uganda: a study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Preterm birth (birth before 37 weeks of gestation) and its complications are the leading contributors to neonatal and under-5 mortality. The majority of neonatal deaths in Kenya and Uganda occur during the intrapartum and immediate postnatal period. This paper describes our study protocol for implementing and evaluating a package of facility-based interventions to improve care during this critical window. METHODS/DESIGN:This is a pair-matched, cluster randomized controlled trial across 20 facilities in Eastern Uganda and Western Kenya. The intervention facilities receive four components: (1) strengthening of routine data collection and data use activities; (2) implementation of the WHO Safe Childbirth Checklist modified for preterm birth; (3) PRONTO simulation training and mentoring to strengthen intrapartum and immediate newborn care; and (4) support of quality improvement teams. The control facilities receive both data strengthening and introduction of the modified checklist. The primary outcome for this study is 28-day mortality rate among preterm infants. The denominator will include all live births and fresh stillbirths weighing greater than 1000 g and less than 2500 g; all live births and fresh stillbirths weighing between 2501 and 3000 g with a documented gestational age less than 37 weeks. DISCUSSION:The results of this study will inform interventions to improve personnel and facility capacity to respond to preterm labor and delivery, as well as care for the preterm infant. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT03112018 . Registered on 13 April 2017.

SUBMITTER: Otieno P

PROVIDER: S-EPMC5989441 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Strengthening intrapartum and immediate newborn care to reduce morbidity and mortality of preterm infants born in health facilities in Migori County, Kenya and Busoga Region, Uganda: a study protocol for a randomized controlled trial.

Otieno Phelgona P Waiswa Peter P Butrick Elizabeth E Namazzi Gertrude G Achola Kevin K Santos Nicole N Keating Ryan R Lester Felicia F Walker Dilys D

Trials 20180605 1

<h4>Background</h4>Preterm birth (birth before 37 weeks of gestation) and its complications are the leading contributors to neonatal and under-5 mortality. The majority of neonatal deaths in Kenya and Uganda occur during the intrapartum and immediate postnatal period. This paper describes our study protocol for implementing and evaluating a package of facility-based interventions to improve care during this critical window.<h4>Methods/design</h4>This is a pair-matched, cluster randomized control ...[more]

PMID: 29871696

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Project description:BackgroundIn spite of considerable improvement in maternal and neonatal outcomes over the past decade in India, the current maternal mortality ratio and neonatal mortality rate are far from the Sustainable Development Goal targets due to suboptimal quality of maternity care. A package of interventions for improving quality of intrapartum and immediate postpartum care was co-designed with the Ministry of Health as the Dakshata program and implemented in public sector health facilities in selected districts in the state of Rajasthan of India since June 2015. This article describes the key strategies, interventions, results and challenges from four years of Dakshata program implementation.MethodsWe have conducted secondary analysis of program data (government data) collected from 202 public facilities across 20 districts of Rajasthan state. The data collected between June-August 2015 (baseline) and the data collected between May-August 2019 (latest) were analyzed. The data sources included: facility assessments, service statistics, monthly progress reports.ResultsDuring the period of program implementation, there were 17,94,249 deliveries accounting for 70% of institutional deliveries in intervention districts. As a result of the intervention, there was a notable increase in competency of health care providers, availability of essential resources, achievement of labour room standards and adherence to evidence-based clinical standards. We also observed reductions in the proportion of referrals for pre-eclampsia/eclampsia, postpartum hemorrhage and neonatal asphyxia by 11, 8 and 3 percentage points respectively. Similarly, data revealed a reduction in stillbirth rates in Dakshata intervention facilities (19.3 vs 15.3) compared to non-Dakshata facilities (21.8 vs 18).ConclusionsOur experience and findings indicate that the quality of intrapartum and immediate postpartum care can be improved in low- and middle-income countries with the approach presented in this paper.

Project description:BACKGROUND:Although gains in newborn survival have been achieved in many low-income and middle-income countries, reductions in stillbirth and neonatal mortality have been slow. Prematurity complications are a major driver of stillbirth and neonatal mortality. We aimed to assess the effect of a quality improvement package for intrapartum and immediate newborn care on stillbirth and preterm neonatal survival in Kenya and Uganda, where evidence-based practices are often underutilised. METHODS:This unblinded cluster-randomised controlled trial was done in western Kenya and eastern Uganda at facilities that provide 24-h maternity care with at least 200 births per year. The study assessed outcomes of low-birthweight and preterm babies. Eligible facilities were pair-matched and randomly assigned (1:1) into either the intervention group or the control group. All facilities received maternity register data strengthening and a modified WHO Safe Childbirth Checklist; facilities in the intervention group additionally received provider mentoring using PRONTO simulation and team training as well as quality improvement collaboratives. Liveborn or fresh stillborn babies who weighed between 1000 g and 2500 g, or less than 3000 g with a recorded gestational age of less than 37 weeks, were included in the analysis. We abstracted data from maternity registers for maternal and birth outcomes. Follow-up was done by phone or in person to identify the status of the infant at 28 days. The primary outcome was fresh stillbirth and 28-day neonatal mortality. This trial is registered with ClinicalTrials.gov, NCT03112018. FINDINGS:Between Oct 1, 2016, and April 30, 2019, 20 facilities were randomly assigned to either the intervention group (n=10) or the control group (n=10). Among 5343 eligible babies in these facilities, we assessed outcomes of 2938 newborn and fresh stillborn babies (1447 in the intervention and 1491 in the control group). 347 (23%) of 1491 infants in the control group were stillborn or died in the neonatal period compared with 221 (15%) of 1447 infants in the intervention group at 28 days (odds ratio 0·66, 95% CI 0·54-0·81). No harm or adverse effects were found. INTERPRETATION:Fresh stillbirth and neonatal mortality among low-birthweight and preterm babies can be decreased using a package of interventions that reinforces evidence-based practices and invests in health system strengthening. FUNDING:Bill & Melinda Gates Foundation.

Project description:BackgroundGlobal neonatal mortality remains unacceptably high. Health workers who attend to prenatal and postnatal mothers need to be knowledgeable in preventive and curative care for pregnant women and their newborn babies. This study aimed to determine the level of knowledge related to prenatal and immediate newborn care among primary healthcare workers in Masindi, Uganda.MethodsA cross-sectional study was conducted. Interviews comprised of 25 multiple-choice questions were administered to health workers who were deployed to offer prenatal and postnatal care in Masindi in November 2011. Questions were related to four domains of knowledge: prenatal care, immediate newborn care, management of neonatal infections and identifying and stabilizing Low-Birth Weight (LBW) babies. Corresponding composite variables were derived; level of knowledge among health workers dichotomized as 'adequate' or 'inadequate'. The chi-square statistic test was used to examine associations with independent variables including level of training (nursing assistant, general nurse or midwife), level of care (hospital/health centre level IV or health centre level III/II) and years of service (five years or less, six years or more).Results183 health workers were interviewed: general nurses (39.3%), midwives (21.9%) and nursing assistants (38.8%). Respectively, 53.6%, 46.5%, 7.1% and 56.3% were considered to have adequate knowledge in prenatal care, newborn care, management of neonatal infections and identifying/stabilizing LBW babies. Being a general nurse was significantly associated with having adequate knowledge in identifying and stabilizing LBW babies (p < 0.001) compared to being a nursing assistant. Level of care being hospital/health centre level IV was not significantly associated with having adequate knowledge in prenatal or newborn care with reference to health centres of level III/II.ConclusionKnowledge regarding prenatal and newborn care among primary healthcare workers in Masindi was very low. The highest deficit of knowledge was in management of neonatal infections. Efforts are needed to orientate health workers regarding prenatal and newborn care especially the offer of infection management among newborns. Similar levels of knowledge between health workers deployed to hospital/health centre level IV and health centres of level III/II raise important implementation questions for the referral system which is crucial for maternal and newborn survival.

Project description:BACKGROUND:Neonatal mortality is a major health burden in Bungoma County with the rate estimated at 31 per 1000 live births and is above the national average of 22 per 1000. Nonetheless, out of the nine sub county hospitals, only two are fairly equipped with necessary infrastructure and skilled personnel to manage neonatal complications such as prematurity, neonatal sepsis, neonatal jaundice, birth asphyxia and respiratory distress syndrome. Additionally, with more than 50% of neonates delivered without skilled attendance, in below par hygiene environments such as home and on the roadsides, with non-existent community based referral system, the situation is made worse. The study aims to evaluate the progress made by an intervention "Collaborative Newborn Support Project" geared towards reducing neonatal mortality rate by 30% between October 2015 and December 2018 in Bungoma County, Kenya. METHODS/DESIGN:This intervention will take a quasi-experimental design approach with experimental and control sites. The project will involve pre- and post-intervention data collection with comparison group to assess intervention effects. The primary outcome will be the percentage reduction of neonatal mortality in Bungoma County. Secondary outcomes include; a) Percentage of mothers or care givers able to identify at least three danger signs in neonates in the project area, b) Proportion of neonates with complications referred to specialized neonatal centers, through the call center, c) Percentage of health providers in neonatal care units who adhere to expected neonatal standards of care (rapid and complete application of standard protocols), d) Percentage increase in neonates with severe complications in the specialized neonatal units and e) Percentage of neonates who stay in neonatal care units beyond 5 days. DISCUSSION:We outline implementation details of the ongoing 'Collaborative Newborn Support Project' in Bungoma County, Kenya. This includes strategies in the operations of the telehealth platform, call centre service, community engagement and measuring of the outputs and outcomes. The funding and ethical approvals have been obtained and the study commenced. TRIAL REGISTRATION:PACTR201712002802638 Retrospectively registered on 5th December 2017 at Pan African Clinical Trials Registry.

Dataset Information

Strengthening intrapartum and immediate newborn care to reduce morbidity and mortality of preterm infants born in health facilities in Migori County, Kenya and Busoga Region, Uganda: a study protocol for a randomized controlled trial.

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Strengthening intrapartum and immediate newborn care to reduce morbidity and mortality of preterm infants born in health facilities in Migori County, Kenya and Busoga Region, Uganda: a study protocol for a randomized controlled trial.

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