The PLANES study: a protocol for a randomised controlled feasibility study of the placental growth factor (PlGF) blood test-informed care versus standard care alone for women with a small for gestational age fetus at or after 32 + 0 weeks' gestation.

BackgroundStillbirth remains a major concern across the globe and in some high-resource countries, such as the UK; efforts to reduce the rate have achieved only modest reductions. One third of stillborn babies are small for gestational age (SGA), and these pregnancies are also at risk of neonatal adverse outcomes and lifelong health problems, especially when delivered preterm. Current UK clinical guidance advocates regular monitoring and early term delivery of the SGA fetus; however, the most appropriate regimen for surveillance of these babies remains unclear and often leads to increased intervention for a large number of these women. This pilot trial will determine the feasibility of a large-scale trial refining the risk of adverse pregnancy outcome in SGA pregnancies using biomarkers of placental function sFlt-1/PlGF, identifying and intervening in only those deemed at highest risk of stillbirth.MethodsPLANES is a randomised controlled feasibility study of women with an SGA fetus that will be conducted at two tertiary care hospitals in the UK. Once identified on ultrasound, women will be randomised into two groups in a 3:1 ratio in favour of sFlt-1/PlGF ratio led management vs standard care. Women with an SGA fetus and a normal sFlt-1/PlGF ratio will have a repeat ultrasound and sFlt-1/PlGF ratio every 2 weeks with planned birth delayed until 40 weeks. In those women with an SGA fetus and an abnormal sFlt-1/PlGF ratio, we will offer birth from 37 weeks or sooner if there are other concerning features on ultrasound. Women assigned to standard care will have an sFlt-1/PlGF ratio taken, but the results will be concealed from the clinical team, and the woman's pregnancy will be managed as per the local NHS hospital policy. This integrated mixed method study will also involve a health economic analysis and a perspective work package exploring trial feasibility through interviews and questionnaires with participants, their partners, and clinicians.DiscussionOur aim is to determine feasibility through the assessment of our ability to recruit and retain participants to the study. Results from this pilot study will inform the design of a future large randomised controlled trial that will be adequately powered for adverse pregnancy outcome. Such a study would provide the evidence needed to guide future management of the SGA fetus.Trial registrationISRCTN58254381 . Registered on 4 July 2019

Multidisciplinary consensus on screening for, diagnosis and management of fetal growth restriction in the Netherlands

Screening for, diagnosis and management of intrauterine growth restriction (IUGR) is often performed in multidisciplinary collaboration. However, variation in screening methods, diagnosis and management of IUGR may lead to confusion. In the Netherlands two monodisciplinary guidelines on IUGR do not fully align. To facilitate effective collaboration between different professionals in perinatal care, we undertook a Delphi study with uniform recommendations as our primary result, focusing on issues that are not aligned or for which specifications are lacking in the current guidelines. We conducted a Delphi study in three rounds. A purposively sampled selection of 56 panellists participated: 27 representing midwife-led care and 29 obstetrician-led care. Consensus was defined as agreement between the professional groups on the same answer and among at least 70% of the panellists within groups. Per round 51 or 52 (91% - 93%) panellists responded. This has led to consensus on 27 issues, leading to four consensus based recommendations on screening for IUGR in midwife-led care and eight consensus based recommendations on diagnosis and eight on management in obstetrician-led care. The multidisciplinary project group decided on four additional recommendations as no consensus was reached by the panel. No recommendations could be made about induction of labour versus expectant monitoring, nor about the choice for a primary caesarean section. We reached consensus on recommendations for care for IUGR within a multidisciplinary panel. These will be implemented in a study on the effectiveness and cost-effectiveness of routine third trimester ultrasound for monitoring fetal growth. Research is needed to evaluate the effects of implementation of these recommendations on perinatal outcomes. NTR436

Supplementary Material for: Survey on the Current Trends in Managing Intrauterine Growth Restriction

<b><i>Objective:</i></b> To provide a snapshot of the current trends in managing intrauterine growth restriction (IUGR) and to assess the agreement on the gestational age and the way of delivery in different clinical scenarios. <b><i>Methods:</i></b> A PubMed search was performed to identify all original articles on IUGR in the last 6 years. The most active 20 authors were selected as experts and were invited to respond to a survey on their preferred gestational age for elective delivery in several IUGR cases depending on Doppler measurements (including umbilical artery (UA), middle cerebral artery, cerebroplacental ratio, uterine artery and ductus venosus), biophysical profile and cardiotocography. <b><i>Results:</i></b> 15 of the 20 selected experts agreed to participate in the survey, of which 3 failed to meet the deadline to complete the survey. Management of IUGR was relatively uniform for abnormal UA, uterine artery or cerebroplacental ratio. Although average gestational age at delivery reflected a clear progression with accepted markers of severity, discrepancies of up to 4 weeks were found for abnormal middle cerebral artery Doppler and absent end-diastolic velocity in the UA, and of up to 8 weeks for reverse end-diastolic velocity in the UA and abnormalities in the ductus venosus Doppler. <b><i>Conclusions:</i></b> Management of IUGR is still far from being uniform among centers, with most controversy surrounding the management of early-onset IUGR. There is a need of prospective studies to address this issue