COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Neonatal Intensive Care Unit admission
研究概览
简要总结
Fetal growth restriction is one of the major causes of perinatal morbidity, mortality and adverse neurological outcome. Growth restricted fetuses do not reach their potential due to multiple factors. Although early (<32 weeks' gestation) FGR is associated with the highest risk of adverse outcomes, late FGR (≤ 32 weeks' gestation) is more common in daily maternal-fetal medicine care. Despite its' prevalence, optimal standard for monitoring differs between the centers and may be difficult in case of limited access to advanced perinatal care. We present a protocol for COmputerized CTG Self-MOnitoring versus Standard Doppler assessment in Late-onset FGR (COSMOS) trial, which is a prospective, cross-over, open-label and randomized trial that compares two different protocols for late-onset FGR observation.
All women carrying fetuses with late-onset FGR with positive end-diastolic flow in umbilical artery will be invited to participate in the randomized trial. Patients will be randomly divided into two groups: CTG - a group that will receive electronic device for cCTG home assessment, and Doppler - a group that will be monitored according to standard Doppler velocimetry criteria. Further management will depend on the arm of the study. Pregnancy and neonatal outcomes will be collected and analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged 18 years or older,
- •singleton pregnancy,
- •≥32+0 and ≤36+6 weeks' of gestation,
- •fluent in Polish or English,
- •diagnosed with late-onset FGR based of the Delphi criteria,
- •with positive EDF in UA,
- •with macroscopically normal fetus on ultrasound assessment.
排除标准
- •multiple pregnancy,
- •fetal malformations,
- •abnormal genetic testing results (if available),
- •uncertain pregnancy dating,
- •indication for immediate delivery within 48 hours after enrollment,
- •preterm prelabour rupture of membranes.
结局指标
主要结局
Neonatal Intensive Care Unit admission
时间窗: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Incidence any admission to the Neonatal Intensive Care Unit
Condition at birth
时间窗: 5 minutes after delivery
Incidence of Apgar score at 5 min \<7 or arterial pH of \<7.0 or venous \<7.1 or resuscitation (compressions, medications, intubation)
Respiratory distress syndrome
时间窗: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
defined as need of surfactant and ventilation as a result of prematurity
Retinopathy
时间窗: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
incidence of retinopathy requiring laser or anti-VEGF administration
Fetal/neonatal death
时间窗: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 4 weeks after delivery if discharged earlier
Rate of death in utero or after delivery before discharge from the hospital or up to 4 weeks after delivery if discharged earlier
Brain injury
时间窗: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Incidence of Intraventricular haemorrhage (IVH) grade II or above-defined as bleeding into the ventricles; or hypoxic-ischaemic encephalopathy or periventricular leukomalacia or seizures recorded by EEG
Ventilation
时间窗: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
defined as need of positive pressure (continuous positive airway pressure (CPAP or nasal CPAP) or intubation rate
Cardiovascular support/treatment
时间窗: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Incidence of anaemia-defined as low haemoglobin and/or haematocrit requiring blood transfusion or DIC - disseminated coagulopathy or ductus arteriosus treatment or hypotensive treatment
Neonatal sepsis
时间窗: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Incidence of confirmed bacteraemia in cultures or necrotizing enterocolitis - Necrotising enterocolitis (NEC)
次要结局
- Maternal anxiety levels(at the recruitment visit and every 2 weeks until delivery)
- Onset of labour(through study completion, an average of 5 weeks after the recruitment visit)
- Number of hospital visits(after the recruitment visit until delivery)
- Compliance(after the recruitment visit until delivery)
- Preeclampsia(between 20 weeks' gestation - up to 6 weeks after birth)
- Mode of delivery(through study completion, an average of 5 weeks after the recruitment visit)
- Gestational hypertension(between 20 weeks' gestation - up to 6 weeks after birth)
研究者
Urszula Nowacka
Principal Investigator
Institute of Mother and Child, Warsaw, Poland