Clinical trial NCT05034861: COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR: COSMOS Study
Official title: COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fetal Growth Restriction
Keywords: fetal growth restriction
fetal growth retardation
pregnancy
cardiotocography
ultrasound
Doppler
intrauterine growth restriction
maternal-fetal medicine
obstetrics
Lead sponsor: Institute of Mother and Child, Warsaw, Poland
Sponsor class: OTHER
Collaborators: name: Bielanski Hospital
First posted: 2021-09-05
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Condition at birth
timeFrame: 5 minutes after delivery
measure: Neonatal Intensive Care Unit admission
timeFrame: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
measure: Brain injury
timeFrame: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
measure: Ventilation
timeFrame: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
measure: Respiratory distress syndrome
timeFrame: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
measure: Cardiovascular support/treatment
timeFrame: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
measure: Neonatal sepsis
timeFrame: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
measure: Retinopathy
timeFrame: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier
measure: Fetal/neonatal death
timeFrame: anytime after the recruitment visit or after delivery before discharge from the hospital or up to 4 weeks after delivery if discharged earlier
Secondary outcomes:
measure: Maternal anxiety levels
timeFrame: at the recruitment visit and every 2 weeks until delivery
measure: Compliance
timeFrame: after the recruitment visit until delivery
measure: Number of hospital visits
timeFrame: after the recruitment visit until delivery
measure: Mode of delivery
timeFrame: through study completion, an average of 5 weeks after the recruitment visit
measure: Onset of labour
timeFrame: through study completion, an average of 5 weeks after the recruitment visit
measure: Gestational hypertension
timeFrame: between 20 weeks' gestation - up to 6 weeks after birth
measure: Preeclampsia
timeFrame: between 20 weeks' gestation - up to 6 weeks after birth
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Institute of Mother and Child
Study officials:
affiliation: Institute of Mother and Child, Warsaw, Poland
name: Urszula Nowacka, MD
role: PRINCIPAL_INVESTIGATOR
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