Maternal Metabolic Health and Mother and Baby Health Outcomes (MAMBO): Protocol of a Prospective Observational Study.

backgroundMetabolic 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 preconception care can largely mitigate the risks of metabolic disease in pregnancy, there are few data about how to identify the highest-risk women so that they can be connected with appropriate preconception care services.

objectiveThe aim of the study is to determine the maternal phenotype that represents the highest risk of having adverse neonatal and maternal pregnancy outcomes.

methodsThis will be a prospective cohort study of 500 women recruited in early pregnancy. The primary outcome is a composite of offspring born small for gestational age (SGA) or large for gestational age (LGA) (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 [T2D] or prediabetes; gestational hypertension, preeclampsia, eclampsia or new essential hypertension after pregnancy; and gestational weight gain ≥20kg or new overweight/obesity at the 12-18 months postpartum visit). A multivariable logistic regression analysis will be conducted to identify candidate predictors of poor pregnancy outcomes due to metabolic disease. From this model, model coefficients and the associated 95% CIs 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).

resultsSeed funding for the project was acquired in November 2022 and subsequent funding was acquired in May 2024. The first participant was recruited on March 23, 2023. At the time of manuscript submission, 402 participants have been recruited. Data analysis has not yet been performed. Results are expected to be published in the first half of 2027.

conclusionsThis is a prospective observational cohort study that intends to identify the metabolic disease risk factors, or combination of factors, that are most likely to cause adverse maternal and fetal health outcomes. These characteristics will be used to develop a risk calculator which will assist in identifying the highest risk women and in triaging them to appropriate services. The study has been approved by the institutional Human Research Ethics Committee (HREC/90080/MH-2022).

trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12623000037606; https://tinyurl.com/yeytsxtp. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/72542.