Dataset Information

I-ACT: Integrated study on effect of Activity on ComplicaTions in pregnancy: study protocol of a multiethnic prospective cohort study.

ABSTRACT: INTRODUCTION:Physical activity (PA) during first 20 weeks of pregnancy may lower risks of gestational diabetes mellitus (GDM) and gestational hypertension (GH), though evidence of association remains inconclusive. Current studies rely heavily on subjective assessment of PA levels. Wearable activity trackers provide a convenient and objective surrogate index for PA validated by evidence-based steps/day categorisation along a physical inactivity/activity continuum. I-ACT primarily aims to examine objectively measured PA levels and patterns in first and second trimesters of pregnancy and the association with GDM and/or GH in Singapore, a multiethnic Asian population. Secondary aims include investigating the bio-socio-demographic factors associated with sedentary behaviour, and association of early pregnancy PA level with maternal weight at 6 weeks postdelivery. Results may facilitate identification of high-risk mothers-to-be and formulation of interventional strategies. METHODS AND ANALYSIS:Prospective cohort study that will recruit 408 women at first antenatal visit at <12 weeks' gestation. Baseline bio-socio-demographic factors and PA levels assessed by participant characteristics form and the International Physical Activity Questionnaire (IPAQ), respectively. An activity tracker (Fitbit) will be provided to be worn daily from date of recruitment to end of 20 weeks' gestation. Tracker-recorded data will be synchronised with an application on participant's smartphone. Compliance will be reinforced with fortnightly reminders. After 20 weeks, a second IPAQ and a feedback form will be administered. GDM screened at 24-28 weeks' gestation. GH diagnosed after 20-weeks gestation. Maternal weight assessed at 6 weeks postdelivery. Appropriate statistical tests will be used to compare continuous and categorical PA measurements between first and second trimesters. Logistic regression will be used to analyse associations. ETHICS AND DISSEMINATION:Ethical approval obtained from the Centralised Institutional Review Board of SingHealth (reference 2017/2836). Dissemination of results will be via peer-reviewed research publications both online and in print, conference presentations, posters and medical forums.

SUBMITTER: Cai M

PROVIDER: S-EPMC6500272 | biostudies-other | 2019 Apr

REPOSITORIES: biostudies-other

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I-ACT: Integrated study on effect of Activity on ComplicaTions in pregnancy: study protocol of a multiethnic prospective cohort study.

Cai Meijin M Tan Kok Hian KH Ang Seng Bin SB

BMJ open 20190403 4

<h4>Introduction</h4>Physical activity (PA) during first 20 weeks of pregnancy may lower risks of gestational diabetes mellitus (GDM) and gestational hypertension (GH), though evidence of association remains inconclusive. Current studies rely heavily on subjective assessment of PA levels. Wearable activity trackers provide a convenient and objective surrogate index for PA validated by evidence-based steps/day categorisation along a physical inactivity/activity continuum. I-ACT primarily aims to ...[more]

PMID: 30948592

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Project description:IntroductionMaternal obesity increases the risk of multiple maternal and infant pregnancy complications, such as gestational diabetes and pre-eclampsia. Current UK guidelines use body mass index (BMI) to identify which women require additional care due to increased risk of complications. However, BMI may not accurately predict which women will develop complications during pregnancy as it does not determine amount and distribution of adipose tissue. Some adiposity measures (eg, waist circumference, ultrasound measures of abdominal visceral fat) can better identify where body fat is stored, which may be useful in predicting those women who need additional care.Methods and analysisThis prospective cohort study (SHAPES, Study of How Adiposity in Pregnancy has an Effect on outcomeS) aims to evaluate the prognostic performance of adiposity measures (either alone or in combination with other adiposity, sociodemographic or clinical measures) to estimate risk of adverse pregnancy outcomes. Pregnant women (n=1400) will be recruited at their first trimester ultrasound scan (11+2-14+1 weeks') at Newcastle upon Tyne National Health Service Foundation Trust, UK. Early pregnancy adiposity measures and clinical and sociodemographic data will be collected. Routine data on maternal and infant pregnancy outcomes will be collected from routine hospital records. Regression methods will be used to compare the different adiposity measures with BMI in terms of their ability to predict pregnancy complications. If no individual measure performs better than BMI, multivariable models will be developed and evaluated to identify the most parsimonious model. The apparent performance of the developed model will be summarised using calibration, discrimination and internal validation analyses.Ethics and disseminationEthical favourable opinion has been obtained from the North East: Newcastle & North Tyneside 1 Research Ethics Committee (REC reference: 22/NE/0035). All participants provide informed consent to take part in SHAPES. Planned dissemination includes peer-reviewed publications and additional dissemination appropriate to target audiences, including policy briefs for policymakers, media/social-media coverage for public and conferences for research TRIAL REGISTRATION NUMBER: ISRCTN82185177.

Project description:BackgroundUntil recently, Zika virus (ZIKV) infections were considered mild and self-limiting. Since 2015, they have been associated with an increase in microcephaly and other birth defects in newborns. While this association has been observed in case reports and epidemiological studies, the nature and extent of the relationship between ZIKV and adverse pregnancy and pediatric health outcomes is not well understood. With the unique opportunity to prospectively explore the full spectrum of issues related to ZIKV exposure during pregnancy, we undertook a multi-country, prospective cohort study to evaluate the association between ZIKV and pregnancy, neonatal, and infant outcomes.MethodsAt research sites in ZIKV endemic regions of Brazil (4 sites), Colombia, Guatemala, Nicaragua, Puerto Rico (2 sites), and Peru, up to 10,000 pregnant women will be recruited and consented in the first and early second trimesters of pregnancy and then followed through delivery up to 6 weeks post-partum; their infants will be followed until at least 1 year of age. Pregnant women with symptomatic ZIKV infection confirmed by presence of ZIKV RNA and/or IgM for ZIKV will also be enrolled, regardless of gestational age. Participants will be tested monthly for ZIKV infection; additional demographic, physical, laboratory and environmental data will be collected to assess the potential interaction of these variables with ZIKV infection. Delivery outcomes and detailed infant assessments, including physical and neurological outcomes, will be obtained.DiscussionWith the emergence of ZIKV in the Americas and its association with adverse pregnancy outcomes in this region, a much better understanding of the spectrum of clinical outcomes associated with exposure to ZIKV during pregnancy is needed. This cohort study will provide information about maternal, fetal, and infant outcomes related to ZIKV infection, including congenital ZIKV syndrome, and manifestations that are not detectable at birth but may appear during the first year of life. In addition, the flexibility of the study design has provided an opportunity to modify study parameters in real time to provide rigorous research data to answer the most critical questions about the impact of congenital ZIKV exposure.Trial registrationNCT02856984 . Registered August 5, 2016. Retrospectively registered.

Dataset Information

I-ACT: Integrated study on effect of Activity on ComplicaTions in pregnancy: study protocol of a multiethnic prospective cohort study.

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I-ACT: Integrated study on effect of Activity on ComplicaTions in pregnancy: study protocol of a multiethnic prospective cohort study.

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