T. Frusca

2 year neurodevelopmental and intermediate perinatal outcomes in infants with very preterm fetal growth restriction (TRUFFLE): A randomised trial

BACKGROUND No consensus exists for the best way to monitor and when to trigger delivery in mothers of babies with fetal growth restriction. We aimed to assess whether changes in the fetal ductus venosus Doppler waveform (DV) could be used as indications for delivery instead of cardiotocography short-term variation (STV). METHODS In this prospective, European multicentre, unblinded, randomised study, we included women with singleton fetuses at 26-32 weeks of gestation who had very preterm fetal growth restriction (ie, low abdominal circumference [<10th percentile] and a high umbilical artery Doppler pulsatility index [>95th percentile]). We randomly allocated women 1:1:1, with randomly sized blocks and stratified by participating centre and gestational age (<29 weeks vs ≥29 weeks), to three timing of delivery plans, which differed according to antenatal monitoring strategies: reduced cardiotocograph fetal heart rate STV (CTG STV), early DV changes (pulsatility index >95th percentile; DV p95), or late DV changes (A wave [the deflection within the venous waveform signifying atrial contraction] at or below baseline; DV no A). The primary outcome was survival without cerebral palsy or neurosensory impairment, or a Bayley III developmental score of less than 85, at 2 years of age. We assessed outcomes in surviving infants with known outcomes at 2 years. We did an intention to treat study for all participants for whom we had data. Safety outcomes were deaths in utero and neonatal deaths and were assessed in all randomly allocated women. This study is registered with ISRCTN, number 56204499. FINDINGS Between Jan 1, 2005 and Oct 1, 2010, 503 of 542 eligible women were randomly allocated to monitoring groups (166 to CTG STV, 167 to DV p95, and 170 to DV no A). The median gestational age at delivery was 30·7 weeks (IQR 29·1-32·1) and mean birthweight was 1019 g (SD 322). The proportion of infants surviving without neuroimpairment did not differ between the CTG STV (111 [77%] of 144 infants with known outcome), DV p95 (119 [84%] of 142), and DV no A (133 [85%] of 157) groups (ptrend=0·09). 12 fetuses (2%) died in utero and 27 (6%) neonatal deaths occurred. Of survivors, more infants where women were randomly assigned to delivery according to late ductus changes (133 [95%] of 140, 95%, 95% CI 90-98) were free of neuroimpairment when compared with those randomly assigned to CTG (111 [85%] of 131, 95% CI 78-90; p=0.005), but this was accompanied by a non-significant increase in perinatal and infant mortality. INTERPRETATION Although the difference in the proportion of infants surviving without neuroimpairment was non-significant at the primary endpoint, timing of delivery based on the study protocol using late changes in the DV waveform might produce an improvement in developmental outcomes at 2 years of age. FUNDING ZonMw, The Netherlands and Dr Hans Ludwig Geisenhofer Foundation, Germany.

Endothelial dysfunction and vascular stiffness in women with previous pregnancy complicated by early or late pre‐eclampsia

Pre‐eclampsia (PE) is associated with an increased cardiovascular risk later in life. The persistence of endothelial dysfunction after delivery may represent the link between PE and cardiovascular disease. We aimed to evaluate endothelial function and arterial stiffness after delivery of pregnancy complicated by early‐onset (EO) or late‐onset (LO) PE and their correlation with gestational age and mean uterine artery pulsatility index at PE diagnosis and birth‐weight percentile.

Placental histological patterns and uterine artery Doppler velocimetry in pregnancies complicated by early or late pre‐eclampsia

To study placental patterns in pregnancies complicated by pre‐eclampsia (PE) and to verify whether the findings are related to gestational age (GA) at PE onset and second‐trimester uterine artery (UtA) Doppler.

Elastic properties of ascending aorta in patients with a previous pregnancy complicated by early or late preeclampsia

To evaluate the elastic properties of the ascending aorta in women with a previous pregnancy complicated by early‐onset (EO) or late‐onset (LO) pre‐eclampsia (PE) and the correlation with gestational age (GA), systolic/diastolic blood pressure (SBP/DBP) and mean uterine artery pulsatility index (UtA‐PI) at diagnosis of the disease as well as with birth weight of the neonate.

Elastic properties of ascending aorta in women with previous pregnancy complicated by early- or late-onset pre-eclampsia.

To evaluate the elastic properties of the ascending aorta in women with a previous pregnancy complicated by early‐onset (EO) or late‐onset (LO) pre‐eclampsia (PE) and the correlation with gestational age (GA), systolic/diastolic blood pressure (SBP/DBP) and mean uterine artery pulsatility index (UtA‐PI) at diagnosis of the disease as well as with birth weight of the neonate.

A narrow subpubic arch angle is associated with a higher risk of persistent posterior occiput position at birth

To determine whether the subpubic arch angle (SPA) measured by three‐dimensional ultrasound is associated with the fetal occiput position at delivery and the mode of delivery.

Narrow subpubic arch angle is associated with higher risk of persistent occiput posterior position at delivery

To determine whether the subpubic arch angle (SPA) measured by three‐dimensional ultrasound is associated with the fetal occiput position at delivery and the mode of delivery.

Longitudinal study of computerized cardiotocography in early fetal growth restriction

To explore whether, in early fetal growth restriction (FGR), the longitudinal pattern of fetal heart rate (FHR) short‐term variation (STV) can be used to identify imminent fetal distress and whether abnormalities of FHR recordings are associated with 2‐year infant outcome.

Budget impact analysis of sFlt-1/PlGF ratio as prediction test in Italian women with suspected preeclampsia

Abstract Introduction: Preeclampsia (PE) is a pregnancy disease which represents a leading cause of maternal and perinatal mortality and morbidity. Accurate prediction of PE risk could provide an increase in health benefits and better patient management. Objective: To estimate the economic impact of introducing Elecsys sFlt-1/PlGF ratio test, in addition to standard practice, for the prediction of PE in women with suspected PE in the Italian National Health Service (INHS). Methods: A decision tree model has been developed to simulate the progression of a cohort of pregnant women from the first presentation of clinical suspicion of PE in the second and third trimesters until delivery. The model provides an estimation of the financial impact of introducing sFlt-1/PlGF versus standard practice. Clinical inputs have been derived from PROGNOSIS study and from literature review, and validated by National Clinical Experts. Resources and unit costs have been obtained from Italian-specific sources. Results: Healthcare costs associated with the management of a pregnant woman with clinical suspicion of PE equal €2384 when following standard practice versus €1714 using sFlt-1/PlGF ratio test. Conclusions: Introduction of sFlt-1/PlGF into hospital practice is cost-saving. Savings are generated primarily through improvement in diagnostic accuracy and reduction in unnecessary hospitalization for women before PE’s onset.

Maternal cardiac function after HELLP syndrome: an echocardiography study

To evaluate maternal hemodynamics in asymptomatic women with a previous pregnancy affected by hemolysis, elevated liver enzymes and low platelets (HELLP) syndrome and compare the findings to those of women with previous pre‐eclampsia (PE) and controls with a previous uncomplicated pregnancy.