Archives of gynecology and obstetrics · 2026
Computerized CTG self-monitoring versus standard Doppler assessment in late-onset fetal growth restriction (cosmos): a pilot randomized controlled trial.
СтатьяРандомизированное исследованиеPragmatic Clinical TrialСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Nowacka Urszula, Issat Tadeusz, Krajewska Karolina, Norwa Agnieszka, Mazanowska Natalia, Kowalczyk-Buss Joanna, Kozlowski Szymon, Kuchcinska Marta, Laudański Piotr, Jakimiuk Artur, Majewska Agata
Аннотация
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.
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.