The CErebro Placental RAtio as indicator for delivery following perception of reduced fetal movements, protocol for an international cluster randomised clinical trial; the CEPRA study

BMC Pregnancy and Childbirth

Henk Groen¹  Wessel Ganzevoort²  Ruben G. Duijnhoven²  Sailesh Kumar³  Sanne J. Gordijn⁴  Stefanie E. Damhuis⁵  Asma Khalil⁶  Alexander E. P. Heazell⁷ 

[1] Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands;Department of Obstetrics and Gynaecology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands;Department of Obstetrics and Gynaecology, Mater Mothers’ Hospital, Mater Research Institute, University of Queensland, Brisbane, QLD, Australia;Department of Obstetrics and Gynaecology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands;Department of Obstetrics and Gynaecology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands;Department of Obstetrics and Gynaecology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands;Fetal Medicine Unit, St George’s University and St George’s University Hospitals NHS Foundation Trust, London, UK;Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute, St George’s University of London, London, UK;Maternal and Fetal Health Research Centre, Mary’s Hospital, University of Manchester and Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK;

关键词: Reduced fetal movements;    Decreased fetal movements;    Cerebroplacental ratio;    CPR;    Placental insufficiency;    Stillbirth;    Fetal hypoxia;    Neonatal morbidity;   

DOI  :  10.1186/s12884-021-03760-2

来源: Springer

【 摘 要 】

BackgroundRoutine assessment in (near) term pregnancy is often inaccurate for the identification of fetuses who are mild to moderately compromised due to placental insufficiency and are at risk of adverse outcomes, especially when fetal size is seemingly within normal range for gestational age. Although biometric measurements and cardiotocography are frequently used, it is known that these techniques have low sensitivity and specificity. In clinical practice this diagnostic uncertainty results in considerable ‘over treatment’ of women with healthy fetuses whilst truly compromised fetuses remain unidentified. The CPR is the ratio of the umbilical artery pulsatility index over the middle cerebral artery pulsatility index. A low CPR reflects fetal redistribution and is thought to be indicative of placental insufficiency independent of actual fetal size, and a marker of adverse outcomes. Its utility as an indicator for delivery in women with reduced fetal movements (RFM) is unknown. The aim of this study is to assess whether expedited delivery of women with RFM identified as high risk on the basis of a low CPR improves neonatal outcomes. Secondary aims include childhood outcomes, maternal obstetric outcomes, and the predictive value of biomarkers for adverse outcomes.MethodsInternational multicentre cluster randomised trial of women with singleton pregnancies with RFM at term, randomised to either an open or concealed arm. Only women with an estimated fetal weight ≥ 10th centile, a fetus in cephalic presentation and normal cardiotocograph are eligible and after informed consent the CPR will be measured. Expedited delivery is recommended in women with a low CPR in the open arm. Women in the concealed arm will not have their CPR results revealed and will receive routine clinical care. The intended sample size based on the primary outcome is 2160 patients. The primary outcome is a composite of: stillbirth, neonatal mortality, Apgar score < 7 at 5 min, cord pH < 7.10, emergency delivery for fetal distress, and severe neonatal morbidity.DiscussionThe CEPRA trial will identify whether the CPR is a good indicator for delivery in women with perceived reduced fetal movements.Trial registrationDutch trial registry (NTR), trial NL7557. Registered 25 February 2019.

【 授权许可】

CC BY