J E Hirst

Gestational weight gain standards based on women enrolled in the Fetal Growth Longitudinal Study of the INTERGROWTH-21st Project: a prospective longitudinal cohort study.

Objective To describe patterns in maternal gestational weight gain (GWG) in healthy pregnancies with good maternal and perinatal outcomes. Design Prospective longitudinal observational study. Setting Eight geographically diverse urban regions in Brazil, China, India, Italy, Kenya, Oman, United Kingdom, and United States, April 2009 to March 2014. Participants Healthy, well nourished, and educated women enrolled in the Fetal Growth Longitudinal Study component of the INTERGROWTH-21st Project, who had a body mass index (BMI) of 18.50-24.99 in the first trimester of pregnancy. Main outcome measures Maternal weight measured with standardised methods and identical equipment every five weeks (plus/minus one week) from the first antenatal visit (<14 weeks’ gestation) to delivery. After confirmation that data from the study sites could be pooled, a multilevel, linear regression analysis accounting for repeated measures, adjusted for gestational age, was applied to produce the GWG values. Results 13 108 pregnant women at <14 weeks’ gestation were screened, and 4607 met the eligibility criteria, provided consent, and were enrolled. The variance within sites (59.6%) was six times higher than the variance between sites (9.6%). The mean GWGs were 1.64 kg, 2.86 kg, 2.86 kg, 2.59 kg, and 2.56 kg for the gestational age windows 14-18+6 weeks, 19-23+6 weeks, 24-28+6 weeks, 29-33+6 weeks, and 34-40+0 weeks, respectively. Total mean weight gain at 40 weeks’ gestation was 13.7 (SD 4.5) kg for 3097 eligible women with a normal BMI in the first trimester. Of all the weight measurements, 71.7% (10 639/14 846) and 94.9% (14 085/14 846) fell within the expected 1 SD and 2 SD thresholds, respectively. Data were used to determine fitted 3rd, 10th, 25th, 50th, 75th, 90th, and 97th smoothed GWG centiles by exact week of gestation, with equations for the mean and standard deviation to calculate any desired centiles according to gestational age in exact weeks. Conclusions Weight gain in pregnancy is similar across the eight populations studied. Therefore, the standards generated in this study of healthy, well nourished women may be used to guide recommendations on optimal gestational weight gain worldwide.

Development of a real-time smartphone solution for the management of women with or at high risk of gestational diabetes.

Background: Gestational diabetes mellitus (GDM) is defined as new onset or recognition of glucose intolerance in pregnancy. Evidence supports tight blood glucose regulation to prevent adverse maternal and fetal outcomes. Finger-prick blood glucose (BG) testing with frequent clinic review remains the most common method of managing diabetes in pregnancy. The prevalence of GDM is rising globally, pressuring resource-limited services. Objectives: We have developed an intuitive, interactive, reliable, and accurate management system to record BG measurements and deliver management of GDM remotely. Methods: Following an initial scoping phase, a prototype software application was developed using an Android smartphone with BG meter linkage via Bluetooth. A custom website was built for clinician review of the data transmitted by the smartphone. After system refinement, further evaluation was undertaken for usability and reliability in a 48-patient service development project. Results: Women used the system for an average of 13.1 weeks. In all, 19 686 BG measures were transmitted, 98.6% of which had a meal tag. A total of 466 text messages were transmitted. A mean of 30 BG readings per woman per week were transmitted, and 85% of women submitted the minimum requirement of 18 readings per week. Discussion: We have developed a novel, real-time, smartphone-based BG monitoring management system that allows clinician review of real-time patient-annotated BG results. Results indicate high usage and excellent compliance by women. Conclusion: Robust clinical, economic, and satisfaction evaluations are required. To address these requirements, we are currently conducting a randomized controlled pilot trial.

Acceptability and User Satisfaction of a Smartphone-Based, Interactive Blood Glucose Management System in Women With Gestational Diabetes Mellitus

Background: The increase in gestational diabetes mellitus (GDM) is challenging maternity services. We have developed an interactive, smartphone-based, remote blood glucose (BG) monitoring system, GDm-health. Aims: The objective was to determine women’s satisfaction with using the GDm-health system and their attitudes toward their diabetes care. Methods: In a service development program involving 52 pregnant women (September 2012 to June 2013), BG was monitored using GDm-health from diagnosis until delivery. Following birth, women completed a structured questionnaire assessing (1) general satisfaction, (2) equipment issues, and (3) relationship with the diabetes care team. Responses were scored on a 7-point Likert-type scale. Reliability and validity of the questionnaire were assessed using statistical methods. Results: Of 52 women, 49 completed the questionnaire; 32 had glucose tolerance test confirmed GDM (gestation at recruitment 29 ± 4 weeks (mean ± SD), and 17 women previous GDM recommended for BG monitoring (18 ± 6 weeks). In all, 45 of 49 women agreed their care was satisfactory and the best for them, 47 of 49 and 43 of 49 agreed the equipment was convenient and reliable respectively, 42 of 49 agreed GDm-health fitted into their lifestyle, and 46 of 49 agreed they had a good relationship with their care team. Written comments supported these findings, with very positive reactions from the majority of women. Cronbach’s alpha was .89 with factor analysis corresponding with question thematic trends. Conclusions: This pilot demonstrates that GDm-health is acceptable and convenient for a large proportion of women. Effects on clinical and economic outcomes are currently under investigation in a randomized trial (clinicaltrials.gov NCT01916694).

The antepartum stillbirth syndrome: risk factors and pregnancy conditions identified from the INTERGROWTH-21st Project

To identify risk factors for antepartum stillbirth, including fetal growth restriction, among women with well‐dated pregnancies and access to antenatal care.

Telemedicine Technologies for Diabetes in Pregnancy: A Systematic Review and Meta-Analysis

Background Diabetes in pregnancy is a global problem. Technological innovations present exciting opportunities for novel approaches to improve clinical care delivery for gestational and other forms of diabetes in pregnancy. Objective To perform an updated and comprehensive systematic review and meta-analysis of the literature to determine whether telemedicine solutions offer any advantages compared with the standard care for women with diabetes in pregnancy. Methods The review was developed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) framework. Randomized controlled trials (RCT) in women with diabetes in pregnancy that compared telemedicine blood glucose monitoring with the standard care were identified. Searches were performed in SCOPUS and PubMed, limited to English language publications between January 2000 and January 2016. Trials that met the eligibility criteria were scored for risk of bias using the Cochrane Collaborations Risk of Bias Tool. A meta-analysis was performed using Review Manager software version 5.3 (Nordic Cochrane Centre, Cochrane Collaboration). Results A total of 7 trials were identified. Meta-analysis demonstrated a modest but statistically significant improvement in HbA1c associated with the use of a telemedicine technology. The mean HbA1c of women using telemedicine was 5.33% (SD 0.70) compared with 5.45% (SD 0.58) in the standard care group, representing a mean difference of −0.12% (95% CI −0.23% to −0.02%). When this comparison was limited to women with gestational diabetes mellitus (GDM) only, the mean HbA1c of women using telemedicine was 5.22% (SD 0.70) compared with 5.37% (SD 0.61) in the standard care group, mean difference −0.14% (95% CI −0.25% to −0.04%). There were no differences in other maternal and neonatal outcomes reported. Conclusions There is currently insufficient evidence that telemedicine technology is superior to standard care for women with diabetes in pregnancy; however, there was no evidence of harm. No trials were identified that assessed patient satisfaction or cost of care delivery, and it may be in these areas where these technologies may be found most valuable.

Monitoring the postnatal growth of preterm infants: A paradigm change

There is no evidence that preterm postnatal growth should mimic that of healthy fetuses. It is seldom achieved and creates extrauterine growth–restricted or overfat infants. There is no consensus regarding how the growth of preterm infants should be monitored or what constitutes their ideal pattern of growth, especially after term-corrected age. The concept that the growth of preterm infants should match that of healthy fetuses is not substantiated by data and, in practice, is seldom attained, particularly for very preterm infants. Hence, by hospital discharge, many preterm infants are classified as postnatal growth–restricted. In a recent systematic review, 61 longitudinal reference charts were identified, most with considerable limitations in the quality of gestational age estimation, anthropometric measures, feeding regimens, and how morbidities were described. We suggest that the correct comparator for assessing the growth of preterm infants, especially those who are moderately or late preterm, is a cohort of preterm newborns (not fetuses or term infants) with an uncomplicated intrauterine life and low neonatal and infant morbidity. Such growth monitoring should be comprehensive, as recommended for term infants, and should include assessments of postnatal length, head circumference, weight/length ratio, and, if possible, fat and fat-free mass. Preterm postnatal growth standards meeting these criteria are now available and may be used to assess preterm infants until 64 weeks’ postmenstrual age (6 months’ corrected age), the time at which they overlap, without the need for any adjustment, with the World Health Organization Child Growth Standards for term newborns. Despite remaining nutritional gaps, 90% of preterm newborns (ie, moderate to late preterm infants) can be monitored by using the International Fetal and Newborn Growth Consortium for the 21st Century Preterm Postnatal Growth Standards from birth until life at home.

International standards for symphysis-fundal height based on serial measurements from the Fetal Growth Longitudinal Study of the INTERGROWTH-21st Project: prospective cohort study in eight countries

Objective To create international symphysis-fundal height standards derived from pregnancies of healthy women with good maternal and perinatal outcomes. Design Prospective longitudinal observational study. Setting Eight geographically diverse urban regions in Brazil, China, India, Italy, Kenya, Oman, United Kingdom, and United States. Participants Healthy, well nourished pregnant women enrolled into the Fetal Growth Longitudinal Study component of the INTERGROWTH-21st Project at 9-14 weeks’ gestation, and followed up until birth. Main outcome measures Symphysis-fundal height was measured every five weeks from 14 weeks’ gestation until birth using standardised methods and dedicated research staff who were blinded to the symphysis-fundal height measurements by turning the tape measure so that numbers were not visible during examination. The best fitting curve was selected using second degree fractional polynomials and further modelled in a multilevel framework to account for the longitudinal design of the study. Results Of 13 108 women screened in the first trimester, 4607 (35.1%) met the study entry criteria. Of the eligible women, 4321 (93.8%) had pregnancies without major complications and delivered live singletons without congenital malformations. The median number of symphysis-fundal height measurements was 5.0 (range 1-7); 3976 (92.0%) women had four or more measurements. Symphysis-fundal height measurements increased almost linearly with gestational age; data were used to determine fitted 3rd, 50th, and 97th centile curves, which showed excellent agreement with observed values. Conclusions This study presents international standards to measure symphysis-fundal height as a first level screening tool for fetal growth disturbances.

Trial protocol to compare the efficacy of a smartphone-based blood glucose management system with standard clinic care in the gestational diabetic population

Introduction The prevalence of gestational diabetes mellitus (GDM) is rising in the UK. Good glycaemic control improves maternal and neonatal outcomes. Frequent clinical review of patients with GDM by healthcare professionals is required owing to the rapidly changing physiology of pregnancy and its unpredictable course. Novel technologies that allow home blood glucose (BG) monitoring with results transmitted in real time to a healthcare professional have the potential to deliver good-quality healthcare to women more conveniently and at a lower cost to the patient and the healthcare provider compared to the conventional face-to-face or telephone-based consultation. We have developed an integrated GDm-health management system and aim to test the impact of using this system on maternal glycaemic control, costs, patient satisfaction and maternal and neonatal outcomes compared to standard clinic care in a single large publicly funded (National Health Service (NHS)) maternity unit. Methods and analysis Women with confirmed gestational diabetes in a current pregnancy are individually randomised to either the GDm-health system and half the normal clinic visits or normal clinic care. Primary outcome is mean BG in each group from recruitment to delivery calculated, with adjustments made for number of BG measurements, proportion of preprandial and postprandial readings and length of time in study, and compared between the groups. The secondary objective will be to compare the two groups for compliance to the allocated BG monitoring regime, maternal and neonatal outcomes, glycaemic control using glycated haemoglobin (HbA1c) and other BG metrics, and patient attitudes to care assessed using a questionnaire and resource use. Ethics and dissemination Thresholds for treatment, dietary advice and clinical management are the same in both groups. The results of the study will be published in a peer-reviewed journal and disseminated electronically and in print. Trial registration number NCT01916694; Pre-results.

Preventing childhood obesity starts during pregnancy

www.thelancet.com Vol 386 September 12, 2015 1039 4 Ball SC, Benjamin SE, Ward DS. Dietary intakes in North Carolina child-care centers: are children meeting current recommendations? J Am Diet Assoc 2008; 108: 718–21. 5 Yoong S, Carey M, Sanson-Fisher R, D’Este C, Mackenzie L, Boyes A. A cross-sectional study examining Australian general practitioners’ identifi cation of overweight and obese patients. J Gen Intern Med 2014; 29: 328–34. 6 Rabin BA, Glasgow RE, Kerner JF, Klump MP, Brownson RC. Dissemination and implementation research on communitybased cancer prevention: a systematic review. Am J Prev Med 2010; 38: 443–56. regulation, is well documented. In the USA, the Healthy, Hunger-Free Kids Act of 2010 recommends that schools ban the sale of all sugar-sweetened beverages, but less than 10% of middle-school and high-school students attend school in districts which ban these drinks. In Australia, less than 40% of schools in all states except for Western Australia comply with mandatory government policies to restrict the sale of unhealthy foods in school canteens, and in Brazil, school canteens frequently sell unhealthy foods that are prohibited. In the USA and Australia, less than 15% of child-care services serve foods consistent with dietary guidelines, and clinicians do not provide recommended weight management care to patients who are overweight. Monitoring of policy implementation and systems of accountability are important, and local practitioners need evidence-based strategies to support policy implementation. A report published by the Agency for Healthcare Research and Quality laid bare the nascent state of community implementation research in the field. Without development of appropriate implementation and supporting policy action, obesity policies will continue not to yield the benefits they were intended to deliver.

Systematic Review of the Methodological Quality of Studies Aimed at Creating Gestational Weight Gain Charts

A range of adverse outcomes is associated with insufficient and excessive maternal weight gain in pregnancy, but there is no consensus regarding what constitutes optimal gestational weight gain (GWG). Differences in the methodological quality of GWG studies may explain the varying chart recommendations. The goal of this systematic review was to evaluate the methodological quality of studies that aimed to create GWG charts by scoring them against a set of predefined, independently agreed-upon criteria. These criteria were divided into 3 domains: study design (12 criteria), statistical methods (7 criteria), and reporting methods (4 criteria). The criteria were broken down further into items, and studies were assigned a quality score (QS) based on these criteria. For each item, studies were scored as either high (score = 0) or low (score = 1) risk of bias; a high QS correlated with a low risk of bias. The maximum possible QS was 34. The systematic search identified 12 eligible studies involving 2,268,556 women from 9 countries; their QSs ranged from 9 (26%) to 29 (85%) (median, 18; 53%). The most common sources for bias were found in study designs (i.e., not prospective); assessments of prepregnancy weight and gestational age; descriptions of weighing protocols; sample size calculations; and the multiple measurements taken at each visit. There is wide variation in the methodological quality of GWG studies constructing charts. High-quality studies are needed to guide future clinical recommendations. We recommend the following main requirements for future studies: prospective design, reliable evaluation of prepregnancy weight and gestational age, detailed description of measurement procedures and protocols, description of sample-size calculation, and the creation of smooth centile charts or z scores.