COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR: COSMOS Study (COSMOS)
Fetal Growth Restriction
About this trial
This is an interventional supportive care trial for Fetal Growth Restriction focused on measuring fetal growth restriction, fetal growth retardation, pregnancy, cardiotocography, ultrasound, Doppler, intrauterine growth restriction, maternal-fetal medicine, obstetrics
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.
Sites / Locations
- Institute of Mother and ChildRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
cCTG
Doppler
cCTG group, that will undergo a following process: EFW and Doppler assessment biweekly, and instead of additional weekly Doppler-only assessment, the patients will be provided with an electronic cCTG device at no cost (Carebits). Women will be asked to apply Carebits device at least twice weekly for at least 30 minutes (e.g. Mondays-Thursdays) with minimum 72 hours interval in case of 2 sessions per week. The trace will be examined by an independent centre, available 24 hours daily. The person examining the trace is trained or already specialized in Obs&Gynae. In case of situation requiring medical intervention, the patient will be immediately contacted by phone and advised to self-refer to the nearest Antenatal Unit. In case of normal trace, a full report will follow within 30 minutes after last reading of the trace.
Doppler group, that will undergo a standard process of antenatal care in case of FGR. The EFW and CTG STV will be assessed biweekly. In case of positive end-diastolic flow in UA, Doppler assessment (MCA PI, UA PI, DV PI, Ut PI) will be provided on a weekly basis. In case of deterioration to AEDF/REDF, further management will depend on clinical situation and the patient will be excluded from the study group (applies to both arms).