Anthropometric standardisation and quality control protocols for the construction of new, international, fetal and newborn growth standards: the INTERGROWTH-21st Project
by INTERGROWTH-21stThe INTERGROWTH-21st Project involved taking anthropometric measurements, including head circumference, recumbent length and weight of infants, and the stature and weight of parents. In a large, international, multicentre project, it is critical that all study sites follow standardised protocols to ensure maximal validity of the growth and nutrition indicators used. This paper describes, in detal, the anthropometric training, standardisation and quality control procedures used to collect data for these new standards. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12127/abstract
Standardisation and quality control of ultrasound measurements taken in the INTERGROWTH-21st Project
by INTERGROWTH-21stMeticulous standardisation and ongoing monitoring of adherence to measurement protocols during data collection are essential to ensure consistency and to minimise systematic error in multicentre studies. Strict ultrasound fetal biometric measurement protocols are used in the INTERGROWTH-21st Project so that data of the highest quality from different centres can be compared and potentially pooled. A central Ultrasound Quality Unit (USQU) has been set up to oversee this standardisation, training and quality control process. This paper describes the procedures used, which can form a model for research settings involving ultrasound measurements.
Ultrasound methodology used to construct the fetal growth standards in the INTERGROWTH-21st Project
by INTERGROWTH-21stA unified protocol is essential to ensure that fetal ultrasound measurements taken in multicentre research studies are accurate and reproducible. This paper describes the methodology used to take two-dimensional, ultrasound measurements in the longitudinal, fetal growth component of the INTERGROWTH-21st Project. These standardised methods should minimise the systematic errors associated with pooling data from different sites. They represent a model for carrying out similar research studies in the future. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12313/abstract
The objectives, design and implementation of the INTERGROWTH-21st Project
by INTERGROWTH-21stThis paper outlines the objectives, design and implementation of the INTERGROWTH-21st Project, a multicentre, multiethnic, population-based project conducted in eight geographical areas (Brazil, China, India, Italy, Kenya, Oman, UK and USA), with technical support from four global specialised units, to study growth, health and nutrition from pregnancy to early infancy. It aims to produce prescriptive growth standards, which conceptually extend the World Health Organization (WHO) Multicentre Growth Reference Study (MGRS) to cover fetal and newborn life. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12047/abstract
Introduction to INTERGROWTH-21st Methodology
by INTERGROWTH-21stZulfiqar Bhutta, Chair of the INTERGROWTH-21st Steering Committee, introduces the rationale for the INTERGROWTH-21st Project. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12032/abstract
Preface to INTERGROWTH-21st Methodology
by INTERGROWTH-21stProfessor Sir Sabaratnam Arulkumaran, President of FIGO, introduces the methods of the INTERGROWTH-21st Project. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12314/abstract
Procedure - Data recording and internal quality checks
by Aileen SheehyProcedure - Data Receipt, Entry and Validation
by Aileen SheehyProcedure - Database Construction and Security
by Aileen SheehyProcedure - Adverse Event Management
by Aileen SheehyProcedure - Serious Adverse Event Management
by Aileen SheehyIdentify, assess, report, and follow serious adverse events occurring in study patients enrolled in an antimalarial drug efficacy trial.
INTERGROWTH-21st Study Protocol
by INTERGROWTH-21stThis study protocol descibes the the objectives, design and implementation of the Fetal Growth Longitudinal Study (FGLS), the Preterm Postnatal Followup Study (PPFS), and the Newborn Cross Sectional Study (NCSS). Data from these studies inform new, international fetal and newborn growth standards and a package of accompanying resources, including a new international equation for estimating gestational age through ultrasound. http://www.medscinet.net/Intergrowth/patientinfodocs/Intergrowth%20Protocol%20Sept%202009.pdf
Fetal Growth Longitudinal Study Operation Manual
by INTERGROWTH-21stThis operation manual was used to implement the Fetal Growth Longitudinal Study (FGLS), which involved screening healthy women between 9 and 14 weeks gestation at the time of their early antenatal visit, and followed-up with standard clinical and 2D ultrasound examinations every 5 weeks, i.e. up to six times during a term pregnancy. The results of the FGLS inform new, international fetal and newborn growth standards and a package of supportive tools, guidelines and resources, including a new international equation for estimating gestational age through ultrasound. http://www.medscinet.net/Intergrowth/patientinfodocs/FGLS%20Manual%2015-09.pdf
Pregnancy and Delivery Form Instructions
by INTERGROWTH-21stThis resource was used to train health professionals on how to record key data on pregnancies and deliveries for women participating in the Fetal Growth Longitudinal Study (FGLS) and Newborn Cross Sectional Study (NCSS). http://www.medscinet.net/Intergrowth/patientinfodocs/Pregnancy%20and%20Delivery%20Form%20Instructions.pdf
Basic Neonatal Care Manual
by INTERGROWTH-21stThe INTERGROWTH-21st Project used this manual to standardize definitions, treatment and management recommendations of neonatal morbidities. http://www.medscinet.net/Intergrowth/patientinfodocs/Neonatal%20Manual%20Final.pdf
Anthropometry Handbook
by INTERGROWTH-21stThis handbook describes the methods used to perform accurate, precise and standardized anthropometric measurements for all components of the INTERGROWTH-21st study, including:
- height and weight of pregnant mothers
- birth weight, length and head circumference of newborns
- weight, length and head circumference of preterm babies
Measurement of Symphysis Fundus Height Protocol
by INTERGROWTH-21stThis protocol outlines the technique for measuring symphysis fundus height. http://www.medscinet.net/Intergrowth/patientinfodocs/Measurement%20of%20Symphysis%20Fundus%20Height.pdf
Blood Pressure Measurement Protocol
by INTERGROWTH-21stThis protocol outlines the technique for taking a pregnant woman's blood pressure. http://www.medscinet.net/Intergrowth/patientinfodocs/BP%20protocol.pdf