Towards risk-guided integrated and tailored care;Early prediction of pregnancy complications to improve perinatal outcomes

BACKGROUND AND RATIONALE: The traditional strategy of Dutch obstetric care is risk stratification and subsequent allocation of women with assumed low risk to the so-called first line of care (mostly midwives, and in some cases general practioners) and those with medium or high risk, based on their medical or obstetric history, to the second or third line (general hospitals or tertiary referral centers). We hypothesize that current risk stratification can be improved by applying screening models for common pregnancy complications, in particular pre-eclampsia (PE) and gestational diabetes mellitus (GDM). PE affects 2-5% of pregnant women and is a leading cause of maternal mortality and perinatal morbidity, such as intrauterine growth restriction, placental abruption, and stillbirth. GDM is present in 5% of all pregnant women and is related to preterm birth, severe congenital malformations, macrosomia, and neonatal hypoglycemia. Moreover, PE and GDM are strongly associated with overweight, type 2 diabetes mellitus, and cardiovascular disease later in life. Early detection of PE and GDM will allow targeted intervention; identification however is unto now restricted to the measurement of clinical parameters which are assessed when the condition has already progressed. Application of these risk assessment models also facilitates intensified antenatal care and timely and appropriate treatment by collaboration between all the ‘lines’ of care. Based on the individual needs of a pregnant woman a multidisciplinary care pathway can be designed which contributes to timely recognition, and thus intervention, in case of complications. On the other hand, women with a low risk pregnancy will not be subject to unnecessary interventions and therapies with this strategy. A substantial part of women however will be at intermediate risk; care provided to them will be multidisciplinary with most antenatal visits in the first line and some visits in the second line. OBJECTIVES: We propose to 1) validate established first trimester screening models for PE and GDM in a large and unselected population for early identification of those at increased risk, and 2) to facilitate risk-guided tailored obstetric care by implementing screening models and appropriate multidisciplinary care pathways. DESIGN AND METHODS: In the first part of this project we will prospectively validate an established algorithm based on maternal characteristics (i.e. age, BMI, ethnicity, obstetric history), arterial blood pressure, biochemical serum markers (PAPP-A and PlGF), and Doppler ultrasound measurements of 4,000 women. The initial algorithm was developed for the early prediction of PE, but slightly adapting the algorithm also allows for screening for GDM (parameters are age, BMI, ethnicity, obstetric history, blood glucose levels). We will determine sensitivity, specificity and appropriate cut-off points of the different models. During this first part of the project, the exact outline of multidisciplinary care pathways for the different risk groups will be developed by the members of the project group and advised by experts in the field. Moreover, we will also develop information for counseling women on their risk and care pathway. In the second part of the project we will implement risk-guided multidisciplinary care into routine obstetric practice to study whether this reduces maternal and perinatal morbidity and mortality. All women in the intervention group receive risk-guided care (n=4,000) while all women in the control group receive care as usual (n=4,000). The primary outcome measurement is a composite outcome of perinatal death (>20 weeks of gestation), preterm birth, perinatal asphyxia and admission to a level III Neonatal Intensive Care Unit. We will also evaluate the preferences and satisfaction of pregnant women and health care professionals towards this health care strategy.