Fetal Growth Restriction
Conditions
Keywords
fetal growth restriction, fetal growth retardation, pregnancy, cardiotocography, ultrasound, Doppler, intrauterine growth restriction, maternal-fetal medicine, obstetrics
Brief summary
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.
Interventions
DEVICEcCTG
Self-applied home computerized CTG device used twice weekly instead of standard Doppler assessment once weekly.
DIAGNOSTIC_TESTDoppler
Standard Doppler assessment provided once weekly in case of late FGR with positive end diastolic flow in the umbilical artery.
Sponsors
Bielanski Hospital
Institute of Mother and Child, Warsaw, Poland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fetal/neonatal death | 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 |
| Neonatal Intensive Care Unit admission | 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 |
| Brain injury | 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 | 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 |
| Respiratory distress syndrome | 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 |
| Cardiovascular support/treatment | 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 | 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) |
| Retinopathy | 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 |
| Condition at birth | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance | after the recruitment visit until delivery | adherence to the plan of care - % of the patients attending scheduled visits |
| Number of hospital visits | after the recruitment visit until delivery | total number of meetings with the healthcare provider |
| Mode of delivery | through study completion, an average of 5 weeks after the recruitment visit | rate of vaginal/caesarean; spontaneous/planned/emergency |
| Onset of labour | through study completion, an average of 5 weeks after the recruitment visit | rate of spontaneous/induced/caesarean before uterine contractions |
| Gestational hypertension | between 20 weeks' gestation - up to 6 weeks after birth | 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) |
| Preeclampsia | between 20 weeks' gestation - up to 6 weeks after birth | incidence of preeclampsia defined by International Society for Study of Hypertension in Pregnancy (ISSHP) (maternal factors) |
| Maternal anxiety levels | at the recruitment visit and every 2 weeks until delivery | 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). |
Countries
Poland
Contacts
Primary ContactUrszula Nowacka, MD
Backup ContactTadeusz Issat, Professor
Outcome results
None listed