INTERGROWTH-21st Gestational Dating and Fetal and Newborn Growth Standards in Peri-Urban Nairobi, Kenya: Quasi-Experimental Implementation Study Protocol.

Kathryn Millar,Aris T Papageorghiou,Rachel M Jones,Nick Pearson,Jose Villar,Faith Muigai,Mary Nell Wegner,Suha Patel,Meghan Munson,Ana Langer,Linda Vesel,Catherine Ongeti,Shalini Subbiah,Sarah Little

doi:10.2196/10293

Abstract

BackgroundThe burden of preterm birth, fetal growth impairment, and associated neonatal deaths disproportionately falls on low- and middle-income countries where modern obstetric tools are not available to date pregnancies and monitor fetal growth accurately. The INTERGROWTH-21st gestational dating, fetal growth monitoring, and newborn size at birth standards make this possible.ObjectiveTo scale up the INTERGROWTH-21st standards, it is essential to assess the feasibility and acceptability of their implementation and their effect on clinical decision-making in a low-resource clinical setting.MethodsThis study protocol describes a pre-post, quasi-experimental implementation study of the standards at Jacaranda Health, a maternity hospital in peri-urban Nairobi, Kenya. All women with viable fetuses receiving antenatal and delivery services, their resulting newborns, and the clinicians caring for them from March 2016 to March 2018 are included. The study comprises a 12-month preimplementation phase, a 12-month implementation phase, and a 5-month post-implementation phase to be completed in August 2018. Quantitative clinical and qualitative data collected during the preimplementation and implementation phases will be assessed. A clinician survey was administered eight months into the implementation phase, month 20 of the study. Implementation outcomes include quantitative and qualitative analyses of feasibility, acceptability, adoption, appropriateness, fidelity, and penetration of the standards. Clinical outcomes include appropriateness of referral and effect of the standards on clinical care and decision-making. Descriptive analyses will be conducted, and comparisons will be made between pre- and postimplementation outcomes. Qualitative data will be analyzed using thematic coding and compared across time. The study was approved by the Amref Ethics and Scientific Review Committee (Kenya) and the Harvard University Institutional Review Board. Study results will be shared with stakeholders through conferences, seminars, publications, and knowledge management platforms.ResultsFrom October 2016 to February 2017, over 90% of all full-time Jacaranda clinicians (26/28) received at least one of the three aspects of the INTERGROWTH-21st training: gestational dating ultrasound, fetal growth monitoring ultrasound, and neonatal anthropometry standards. Following the training, implementation and evaluation of the standards in Jacaranda Health’s clinical workflow will take place from March 2017 through March 5, 2018. Data analysis will be finalized, and results will be shared by August 2018.ConclusionsThe findings of this study will have major implications on the national and global scale up of the INTERGROWTH-21st standards and on the process of scaling up global standards in general, particularly in limited-resource settings.Registered Report IdentifierRR1-10.2196/10293

Highlights

BackgroundThe neonatal period is the most vulnerable time for an infant’s survival
From October 2016 to February 2017, over 90% of all full-time Jacaranda clinicians (26/28) received at least one of the three aspects of the INTERGROWTH-21st training: gestational dating ultrasound, fetal growth monitoring ultrasound, and neonatal anthropometry standards
A common condition associated with preterm birth is low birth weight (LBW;

Summary

Introduction

BackgroundThe neonatal period (first 28 days of life) is the most vulnerable time for an infant’s survival. In 2016, 2.6 million neonates died globally representing 46% of all under-five deaths [1]. Most of these deaths took place in low- and middle-income countries (LMICs), including 80% in sub-Saharan Africa and South Asia [1]. There are two causes of LBW in neonates: prematurity, growth restriction during pregnancy resulting in a birthweight that is small for gestational age (SGA) [8], or a combination of the two conditions. The burden of preterm birth, fetal growth impairment, and associated neonatal deaths disproportionately falls on low- and middle-income countries where modern obstetric tools are not available to date pregnancies and monitor fetal growth accurately. The INTERGROWTH-21st gestational dating, fetal growth monitoring, and newborn size at birth standards make this possible

Methods

Results

Conclusion