Department of Women and Children's Health, School of Life Course Sciences, King's College London, Westminster Bridge Road, London, SE1 7EH, UK.
Maternal & Fetal Health Research Centre, Division of Developmental Biology and Medicine, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, M13 9PL, UK.
Trials. 2022 Sep 2;23(1):722. doi: 10.1186/s13063-022-06652-8.
Pre-eclampsia is a complex pregnancy disorder, characterised by new or worsening hypertension associated with multi-organ dysfunction. Adverse outcomes include eclampsia, liver rupture, stroke, pulmonary oedema, and acute kidney injury in the mother, and stillbirth, foetal growth restriction, and iatrogenic preterm delivery for the foetus. Angiogenic biomarkers, including placental growth factor (PlGF) and soluble fms-like tyrosine kinase 1 (sFlt-1), have been identified as valuable biomarkers for preterm pre-eclampsia, accelerating diagnosis and reducing maternal adverse outcomes by risk stratification, with enhanced surveillance for high-risk women. PlGF-based testing for suspected preterm pre-eclampsia has been incorporated into national guidance. The role of repeat PlGF-based testing and its effect on maternal and perinatal adverse outcomes have yet to be evaluated.
The PARROT-2 trial is a multi-centre randomised controlled trial of repeat revealed PlGF-based testing compared to repeat concealed testing, in women presenting with suspected pre-eclampsia between 22 and 35 weeks' gestation. The primary objective is to establish whether repeat PlGF-based testing decreases a composite of perinatal severe adverse outcomes (stillbirth, early neonatal death, or neonatal unit admission). All women prior to enrolment in the trial will have an initial revealed PlGF-based test. Repeat PlGF-based tests will be performed weekly or two-weekly, depending on the initial PlGF-based test result, with results randomised to revealed or concealed.
National guidance recommends that all women presenting with suspected preterm pre-eclampsia should have a single PlGF-based test when disease is first suspected, to help rule out pre-eclampsia. Clinical and cost-effectiveness of repeat PlGF-based testing has yet to be investigated. This trial aims to address whether repeat PlGF-based testing reduces severe maternal and perinatal adverse outcomes and whether repeat testing is cost-effective.
ISRCTN 85912420 . Registered on 25 November 2019.
子痫前期是一种复杂的妊娠疾病，其特征是新出现或恶化的高血压伴有多器官功能障碍。不良结局包括母亲发生子痫、肝破裂、中风、肺水肿和急性肾损伤，以及胎儿发生死产、生长受限和医源性早产。血管生成生物标志物，包括胎盘生长因子（PlGF）和可溶性 fms 样酪氨酸激酶 1（sFlt-1），已被确定为早产子痫前期的有价值的生物标志物，通过风险分层加速诊断并减少母亲的不良结局，对高危妇女进行强化监测。基于 PlGF 的检测用于疑似早产子痫前期已被纳入国家指南。重复 PlGF 检测的作用及其对母婴不良结局的影响尚未得到评估。
PARROT-2 试验是一项多中心随机对照试验，比较了重复揭示 PlGF 检测与重复隐匿 PlGF 检测在 22 至 35 孕周疑似子痫前期孕妇中的应用。主要目的是确定重复 PlGF 检测是否减少围产儿严重不良结局（死产、新生儿早期死亡或新生儿重症监护病房入院）的复合结局。所有入组前将进行初始揭示 PlGF 检测。根据初始 PlGF 检测结果，每周或每两周重复进行 PlGF 检测，结果随机显示或隐匿。
国家指南建议，所有首次怀疑存在早产子痫前期的孕妇均应进行单次 PlGF 检测，以帮助排除子痫前期。重复 PlGF 检测的临床和成本效益尚未得到研究。本试验旨在确定重复 PlGF 检测是否减少严重母婴不良结局，以及重复检测是否具有成本效益。
ISRCTN85912420。于 2019 年 11 月 25 日注册。
