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.
BMC Pregnancy Childbirth. 2021 Apr 9;21(1):285. doi: 10.1186/s12884-021-03760-2.
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.
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.
The CEPRA trial will identify whether the CPR is a good indicator for delivery in women with perceived reduced fetal movements.
Dutch trial registry (NTR), trial NL7557 . Registered 25 February 2019.
常规评估（临近）妊娠通常无法准确识别因胎盘功能不全而轻度至中度受损且存在不良结局风险的胎儿，尤其是当胎儿大小看似在孕龄正常范围内时。尽管生物测量和胎心监护图经常被使用，但已知这些技术的敏感性和特异性较低。在临床实践中，这种诊断不确定性导致对健康胎儿的过度治疗相当多，而真正受损的胎儿仍然未被识别。CPR 是脐动脉搏动指数与大脑中动脉搏动指数的比值。低 CPR 反映胎儿重新分布，被认为是胎盘功能不全的独立指标，与实际胎儿大小无关，也是不良结局的标志物。其作为减少胎儿运动（RFM）妇女分娩的指标的效用尚不清楚。本研究旨在评估基于低 CPR 识别为高危的 RFM 妇女的加速分娩是否改善新生儿结局。次要目标包括儿童结局、产妇产科结局以及生物标志物对不良结局的预测价值。
在足月时患有 RFM 的单胎妊娠妇女中进行国际多中心集群随机试验，随机分为开放或隐蔽臂。只有估计胎儿体重≥第 10 百分位数、胎儿头位且正常胎心监护图的妇女有资格参加，在知情同意后将测量 CPR。在开放臂中，CPR 低值的妇女建议加速分娩。隐蔽臂中的妇女不会透露她们的 CPR 结果，将接受常规临床护理。基于主要结局的预期样本量为 2160 例患者。主要结局是：死产、新生儿死亡率、5 分钟时 Apgar 评分<7、脐动脉 pH<7.10、因胎儿窘迫紧急分娩和严重新生儿发病率。
CEPRA 试验将确定 CPR 是否是感知到的减少胎儿运动的妇女分娩的良好指标。
荷兰试验注册处（NTR），试验 NL7557。于 2019 年 2 月 25 日注册。
