Maternal metabolic health And Mother and Baby health Outcomes (MAMBO): Protocol of a prospective observational study (Preprint)

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BACKGROUND Metabolic disease is increasingly impacting women of reproductive age. In pregnancy, uncontrolled metabolic disease can result in offspring with major congenital anomalies, preterm birth, and abnormal fetal growth. Pregnancy also accelerates the complications of metabolic diseases in mothers resulting in an increased risk of premature cardiovascular events. Despite the convincing evidence that pre-conception care can largely mitigate the risks of metabolic disease in pregnancy, there are few data about how to identify the highest risk women to enable them to be connected with appropriate pre-conception care services. OBJECTIVE Despite the convincing evidence that pre-conception care can largely mitigate the risks of metabolic disease in pregnancy, there are few data about how to identify the highest risk women to enable them to be connected with appropriate pre-conception care services. The aim of the study is to determine the maternal phenotype that represents the highest risk of having adverse neonatal and maternal pregnancy outcomes. METHODS This will be a prospective cohort study of 500 women recruited in early pregnancy. The primary outcome is a composite of offspring born small or large for gestational age (customized birthweight ≤10th and ≥90th centile for gestational age). Secondary outcomes are (1) composite of adverse neonatal birth outcomes (SGA, LGA, major congenital abnormalities, preterm birth (<37 weeks’ gestation)) and (2) composite of new maternal metabolic outcomes (gestational diabetes, diabetes in pregnancy, Type 2 Diabetes or pre-diabetes; gestational hypertension, preeclampsia, eclampsia or new essential hypertension after pregnancy; and gestational weight gain ≥20kg or new overweight/obesity at the 12–18-months post-partum visit). RESULTS A multivariable logistic regression analysis will be conducted to identify candidate predicators of poor pregnancy outcomes due to metabolic disease. From this model, model coefficients and the associated 95% confidence intervals (CI) will be extracted to derive the risk score for predicting the delivery of LGA/SGA offspring (primary outcome) and composites of adverse neonatal outcomes and maternal outcomes (secondary outcomes). CONCLUSIONS The study has been approved by the institutional Human Research Ethics Committee (HREC/90080/MH-2022). Findings will be disseminated through peer reviewed publications and conference presentations, and national and international networks involved in maternity care in high-risk populations. CLINICALTRIAL This study has been prospective registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623000037606).

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