Computerized CTG self-monitoring versus standard Doppler assessment in late-onset fetal growth restriction (cosmos): a pilot randomized controlled trial.

PURPOSE: Late-onset fetal growth restriction (FGR) presents clinical management challenges, often requiring frequent in-hospital fetal surveillance. Telemedicine-based computerized cardiotocography (cCTG) performed at home may offer a viable remote monitoring addition.

METHODS

This single-center, open-label, a pilot randomized controlled pragmatic trial (COSMOS) was conducted in Warsaw, Poland, between 2022 and 2025. A total of 120 women with late-onset FGR, defined according to the Delphi criteria, were randomly assigned (1:1) to either a cCTG-based monitoring approach with protocol-mandated safety Doppler assessments or to standard hospital-based Doppler surveillance. The primary outcome was neonatal condition at birth (Apgar score at 5 min, umbilical artery pH). Secondary outcomes included emergency cesarean section for fetal compromise, maternal anxiety, measured using the Generalized Anxiety Disorder 7-item scale (GAD-7), number of antenatal visits, and a composite of adverse neonatal outcomes. The study protocol was registered at ClinicalTrials.gov (NCT05034861).

RESULTS

There were no significant differences between groups in Apgar scores, umbilical cord arterial pH, or need for neonatal resuscitation. The rate of emergency cesarean delivery was lower in the cCTG-based group. Women in the cCTG-based group also reported significantly lower anxiety levels at delivery and required fewer antenatal visits, with no increase in adverse neonatal outcomes.

CONCLUSIONS

Home-based computerized CTG within a pragmatic real-world framework appears feasible in pregnancies complicated by late-onset FGR. These findings support the potential of this approach to reduce hospital-based monitoring, maternal anxiety and in-person visits; however, these results should be considered hypothesis-generating and not indicative of clinical effectiveness.

CLINICAL TRIALS REGISTRATION: Date 13.08.2021 NCT Number NCT05034861.