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

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

Implementation of the INTERGROWTH-21 st gestational dating and fetal and newborn growth standards in Nairobi, Kenya: women’s experiences with ultrasound and newborn assessment

“…The results shared in this paper are part of a larger study, which was conducted over two years (March 2016 -March 2018), before (12-month pre-implementation phase) and during (12-month implementation phase) the introduction of the INTERGROWTH-21 st standards [23]. Before implementation of the INTERGROWTH-21 st standards, ultrasounds were not performed routinely and were only administered by an ultrasonographer upon patient request or when clinically indicated.…”

“…Full details of the study design and methods can be found in the protocol paper [23]. Provider experiences, uptake of the standards, and the association between the implementation of the standards and clinical decision-making outcomes are discussed in a separate paper [24].…”

Implementing the INTERGROWTH-21st gestational dating and fetal and newborn growth standards in peri-urban Nairobi, Kenya: Provider experiences, uptake and clinical decision-making

“…All fetal growth monitoring scans were performed by the resident expert sonographer. Further details of the study setting, design and description can be found in the study protocol paper [15].…”

INTERGROWTH-21st versus a customized method for the prediction of neonatal nutritional status in hypertensive disorders of pregnancy

“…Traditionally, foetal growth has been evaluated by comparing estimated foetal weights with population-based reference curves. Likewise, some recent reports of the INTERGROWTH-21st project recommend using a single standard for both foetal growth and birthweight [ 11 , 12 ].…”

“…Two competing approaches have been proposed for the detection of SGA, including the INTERGROWTH-21st project [ 11 , 13 ] and a customized approach that assumes that one foetal growth standard does not fit all foetuses and has resulted in proposing customized standards [ 14 , 15 ]. In the latter approach, the optimal weight at term for each fetus is estimated using a mathematical model estimated from foetal and maternal anthropometric variables [ 14 , 15 ].…”