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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.

Damhuis, SE; Ganzevoort, W; Duijnhoven, RG; Groen, H; Kumar, S; Heazell, AEP; Khalil, A; Gordijn, SJ (2021) 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 Childbirth, 21 (1). p. 285. ISSN 1471-2393 https://doi.org/10.1186/s12884-021-03760-2
SGUL Authors: Khalil, Asma

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Abstract

BACKGROUND: Routine 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. METHODS: International 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. DISCUSSION: The CEPRA trial will identify whether the CPR is a good indicator for delivery in women with perceived reduced fetal movements. TRIAL REGISTRATION: Dutch trial registry (NTR), trial NL7557 . Registered 25 February 2019.

Item Type: Article
Additional Information: © The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtainpermission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Keywords: CPR, Cerebroplacental ratio, Decreased fetal movements, Fetal hypoxia, Neonatal morbidity, Placental insufficiency, Reduced fetal movements, Stillbirth, Obstetrics & Reproductive Medicine, 1114 Paediatrics and Reproductive Medicine, 1117 Public Health and Health Services, 1110 Nursing
SGUL Research Institute / Research Centre: Academic Structure > Molecular and Clinical Sciences Research Institute (MCS)
Journal or Publication Title: BMC Pregnancy Childbirth
ISSN: 1471-2393
Language: eng
Dates:
DateEvent
9 April 2021Published
26 March 2021Accepted
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
852002034ZonMwUNSPECIFIED
PubMed ID: 33836690
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/113179
Publisher's version: https://doi.org/10.1186/s12884-021-03760-2

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