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Predicting outcomes in selective fetal growth restriction of monoChOrioNic Twins: an inteRnAtional observational cohort STudy protocol (CONTRAST study)

Por: Noll · A. · Javinani · A. · Slaghekke · F. · Haak · M. C. · van Klink · J. · Van der Meeren · L. · Lopriore · E. · Russo · F. · Aertsen · M. · Shamshirsaz · A. · Shinar · S. · Bennasar · M. · Tiblad · E. · Herling · L. · Lewi · L. · Verweij · E. · CONTRAST Study Group · Keizer · Steggerd
Introduction

Selective fetal growth restriction (sFGR) is a major cause of perinatal morbidity and mortality in monochorionic diamniotic (MCDA) twin pregnancies. Current management relies on umbilical artery Doppler patterns in the smaller twin. These patterns are, however, inconsistent and do not represent a reliable severity scale, complicating clinical decision-making and parental counselling. This study aims to improve risk stratification by identifying predictors of adverse outcomes, while also evaluating the pathophysiology and multi-organ impact of sFGR in early childhood.

Methods and analysis

This is a prospective, international, multicentre cohort study conducted in six tertiary fetal medicine centres with expertise in complicated twin pregnancies. Recruitment began in March 2023 and will continue until December 2026, targeting 274 MCDA twin pairs with complete follow-up to develop a prediction model for adverse perinatal outcomes in sFGR at the time of diagnosis. Standardised data collection includes serial ultrasound examinations, advanced fetal imaging (cardiac, cerebral and 3D volumetric), fetal brain MRI and detailed placental phenotyping. Maternal and parental well-being are assessed during pregnancy and after birth. Neurodevelopmental outcome is evaluated up to 2 years after birth using validated tools. The statistical analysis plan includes predictive modelling with internal validation.

Ethics and dissemination

The study has been approved by the ethical review boards of all participating centres. Findings will be disseminated through peer-reviewed publications, international conferences and engagement with clinical guideline committees.

Trial registration number

NCT05952583.

Influence of Social Determinants of Health on Adherence to Lifestyle Modifications in Individuals With Prediabetes: A Mixed Methods Study

ABSTRACT

Aim

To explore the relationship between social determinants of health and adherence to lifestyle recommendations, and how these determinants can help explain contextual and interpersonal factors contributing to adherence among individuals with prediabetes.

Design

Explanatory sequential mixed methods study integrating a cross-sectional quantitative analysis with an ethnomethodological qualitative approach grounded in critical social paradigm.

Methods

The quantitative phase used data from the intervention arm (n = 86) of the PREDIPHONE trial, a randomised controlled study evaluating the effectiveness of a nurse-led telephone intervention for lifestyle changes in glycaemic control. Adherence was measured using a composite index, analysed as both a continuous and categorical variable. Correlation analysis examined adherence and age. Chi-square and ANOVA tests were used to analyse differences in participant characteristics across adherence quartiles. The qualitative phase included individual semi-structured interviews and a focus group with participants showing high or low adherence. Thematic content and discourse analysis were employed, ensuring validity through triangulation, reflexivity and discourse saturation.

Results

Employment status was identified as a significant factor, with unemployed or retired participants showing better adherence. Although no statistical differences in adherence were found by social class or gender, lower social class participants reported financial barriers to healthy eating and time constraints limiting physical activity (PA). Women reported facing greater challenges due to caregiving responsibilities, whereas men benefited from household support.

Conclusions

Employment status emerged as a determinant of time availability for self-care, alongside social class and gender in adherence to lifestyle modifications. Women, especially those from lower social classes, experienced heightened barriers to adherence, underscoring the need for tailored, gender-sensitive and equity-focused interventions.

Implications

Addressing social determinants is essential for effective lifestyle advice among individuals with prediabetes.

Impact

The study highlights the role of social class and gender in adherence.

Reporting Method

STROBE and COREQ guidelines.

Patient Contribution

Through interviews and focus group.

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