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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
150
Institute of Mother and Child
Warsaw, Poland
RECRUITINGCondition at birth
Incidence of Apgar score at 5 min \<7 or arterial pH of \<7.0 or venous \<7.1 or resuscitation (compressions, medications, intubation)
Time frame: 5 minutes after delivery
Neonatal Intensive Care Unit admission
Incidence any admission to the Neonatal Intensive Care Unit
Time frame: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Brain injury
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
Time frame: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Ventilation
defined as need of positive pressure (continuous positive airway pressure (CPAP or nasal CPAP) or intubation rate
Time frame: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Respiratory distress syndrome
defined as need of surfactant and ventilation as a result of prematurity
Time frame: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Cardiovascular support/treatment
Incidence of anaemia-defined as low haemoglobin and/or haematocrit requiring blood transfusion or DIC - disseminated coagulopathy or ductus arteriosus treatment or hypotensive treatment
Time frame: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Neonatal sepsis
Incidence of confirmed bacteraemia in cultures or necrotizing enterocolitis \- Necrotising enterocolitis (NEC)
Time frame: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Retinopathy
incidence of retinopathy requiring laser or anti-VEGF administration
Time frame: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
Fetal/neonatal death
Rate of death in utero or after delivery before discharge from the hospital or up to 4 weeks after delivery if discharged earlier
Time frame: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 4 weeks after delivery if discharged earlier
Maternal anxiety levels
measured by a screening Generalized Anxiety Disorder 7- question scale (GAD-7 scale). There are four possible answers to all the questions, corresponding to scores 0,1,2,3, respectively, therefore the total score ranges between 0 (not anxious) - 21 (severely anxious).
Time frame: at the recruitment visit and every 2 weeks until delivery
Compliance
adherence to the plan of care - % of the patients attending scheduled visits
Time frame: after the recruitment visit until delivery
Number of hospital visits
total number of meetings with the healthcare provider
Time frame: after the recruitment visit until delivery
Mode of delivery
rate of vaginal/caesarean; spontaneous/planned/emergency
Time frame: through study completion, an average of 5 weeks after the recruitment visit
Onset of labour
rate of spontaneous/induced/caesarean before uterine contractions
Time frame: through study completion, an average of 5 weeks after the recruitment visit
Gestational hypertension
incidence of new onset hypertension (blood pressure ≥140/90 mmHg) after 20 weeks' of gestation in the absence of preeclampsia as defined by International Society for Study of Hypertension in Pregnancy (ISSHP)
Time frame: between 20 weeks' gestation - up to 6 weeks after birth
Preeclampsia
incidence of preeclampsia defined by International Society for Study of Hypertension in Pregnancy (ISSHP) (maternal factors)
Time frame: between 20 weeks' gestation - up to 6 weeks after birth
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