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

BackgroundPreterm 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/designThis 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.DiscussionThe 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 registrationClinicalTrials.gov, ID: NCT03112018. Registered on 13 April 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2696-2) contains supplementary material, which is available to authorized users.

Effect of a quality improvement package for intrapartum and immediate newborn care on fresh stillbirth and neonatal mortality among preterm and low-birthweight babies in Kenya and Uganda: a cluster-randomised facility-based trial

“…An unblinded, pair-matched cluster-randomised controlled trial was implemented in public sector facilities in Uganda and public sector facilities in Kenya. 20 All interventions were delivered at the facility level. The study was done in the Busoga region in eastern Uganda (with a population of 3 million) and in Migori County in western Kenya (with a population of 1 million).…”

Neurodevelopmental outcomes of preterm babies during infancy in Eastern Uganda: a prospective cohort study

“…The unit had incubators, oxygen cylinders and concentrators, a phototherapy machine, an improvised continuous positive airway pressure (CPAP) machine and other supplies essential for neonatal care. The hospital was one of the study sites for the Preterm Birth Initiative study (2016 to 2019) which provided some of the equipment and essential supplies at the start of the intervention [ 23 , 24 ]. However, there was no access to surfactant to treat Respiratory Distress Syndrome, and magnesium sulphate was not in use for neonatal brain protection among women with imminent birth.…”

Efficacy of an ultrasound training program for nurse midwives to assess high-risk conditions at labor triage in rural Uganda

“…Based on maternity register data from March 2016 to March 2017, the DH had a delivery volume of approximately 664 births/month, a caesarean section rate of 27% and an estimated 20% of deliveries had one or more of the 6 high risk conditions featured in this training. These data were collected as part of a cluster randomized controlled trial aimed at improving intrapartum and immediate newborn quality of care [16]. Three regional HCs were also included as study sites, with lower delivery volumes (approximately 70 deliveries/month at each HC) and no Cesarean capacity at the time of study initiation.…”

“…Images for Weeks 1-8 were reviewed for all four facilities. Images were scored individually for acceptability based on quality using the American College of Emergency Physicians (ACEP) Quality assurance 5-point grading scale [16] (1 and 2 are uninterpretable, while 3, 4, or 5 are adequate for interpretation), and any measurement errors were categorized individually as reasons to deem images unacceptable. After a relative plateau of acceptable image rate and error rate was achieved, a random selection of cases was chosen for determination of inter-rater reliability between the two QA reviewers.…”