RESUMEN
BACKGROUND: Stillbirth 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. METHODS: PLANES 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. DISCUSSION: Our 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 REGISTRATION: ISRCTN58254381 . Registered on 4 July 2019.
RESUMEN
OBJECTIVES: To identify variation in the antenatal management of multiple pregnancy. The UK has 10,000 twin pregnancies per year. There is established guidance on the management of dichorionic (DC) and monochorionic (MC) twin pregnancy from both the RCOG and NICE, however it is likely that the provision and practice of multiple pregnancy management varies amongst units. DESIGN: Questionnaires were posted to 151 UK maternity units in 3 rounds from May to November 2019. RESULTS: 60 responses were received (range 11,500 to 501 deliveries), with annual multiple pregnancy rates of 190 to 4. 25 % of units did not offer a dedicated twin clinic and less than 15 % of units provided dedicated multiple pregnancy midwifery staff for intrapartum and postnatal care. Cervical length screening was performed in 24 % of units with 84 % of units offering treatment for a short cervix. 15 % of units prescribed Aspirin to all multiples, 47 % prescribing 75 mg and 43 % 150 mg. Monitoring of MC pregnancies varied with 18 % of units not measuring Middle Cerebral Artery and 29 % Ductus Venosus Dopplers. Mean caesarean section rate was 61.7 %. Delivery was offered from 37 weeks in 93 % of DC twins and from 36 weeks in 90 % MC twins. 5% of MC twins were given non labouring prophylactic antenatal steroids. CONCLUSION: Despite well-established national guidance for twin pregnancy management there remains a wide variation in practice among units in the provision and antenatal management of multiple pregnancies throughout the UK. The exact reasons for this variation require further exploration.