Evidence map›Paper›PMID 42323763›Full record

Trial reportArchives of gynecology and obstetrics2026

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

Urszula Nowacka, Tadeusz Issat, Karolina Krajewska, Agnieszka Norwa, Natalia Mazanowska, Joanna Kowalczyk-Buss, Szymon Kozlowski, Marta Kuchcinska, Piotr Laudański, Artur Jakimiuk and 1 more

Registry-linked trialAbstract readRandomized Controlled TrialPragmatic Clinical TrialComparative Study
In one paragraph

Trial report in Archives of gynecology and obstetrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05034861 (COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05034861 naunknown statusnot on this map

COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR: Study Protocol for a Randomized Controlled Trial

TypeinterventionalSponsorInstitute of Mother and Child, Warsaw, PolandRan2022 to 2024Enrolled150ConditionsFetal Growth RestrictionArmscCTG, Doppler
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Urszula NowackaDepartment of Obstetrics and Gynaecology, Institute of Mother and Child, Warsaw, Poland. urszula.nowacka@imid.med.pl.ORCID http://orcid.org/0000-0001-8220-969X
Tadeusz IssatDepartment of Obstetrics and Gynaecology, Institute of Mother and Child, Warsaw, Poland.ORCID http://orcid.org/0000-0002-3647-3550
Karolina KrajewskaDepartment of Obstetrics and Gynaecology, Institute of Mother and Child, Warsaw, Poland.ORCID http://orcid.org/0000-0001-5779-8517
Agnieszka NorwaDepartment of Obstetrics and Gynaecology, Institute of Mother and Child, Warsaw, Poland.ORCID http://orcid.org/0009-0009-1016-5662
Natalia MazanowskaDepartment of Obstetrics and Gynaecology, Institute of Mother and Child, Warsaw, Poland.ORCID http://orcid.org/0000-0002-6970-5303
Joanna Kowalczyk-BussDepartment of Obstetrics and Gynaecology, Institute of Mother and Child, Warsaw, Poland.ORCID http://orcid.org/0009-0004-3997-1872
Szymon KozlowskiDepartment of Obstetrics and Gynaecology, Institute of Mother and Child, Warsaw, Poland.ORCID http://orcid.org/0000-0002-5492-0676
Marta KuchcinskaDepartment of Obstetrics and Gynaecology, Institute of Mother and Child, Warsaw, Poland.ORCID http://orcid.org/0000-0001-9056-7040
Piotr LaudańskiDepartment of Obstetrics, Gynaecology and Gynaecological Oncology, Medical University of Warsaw, 03-242, Warsaw, Poland.ORCID http://orcid.org/0000-0001-8955-8198
Artur JakimiukDepartment of Obstetrics and Gynaecology, Institute of Mother and Child, Warsaw, Poland.ORCID http://orcid.org/0000-0002-7373-7690
Agata MajewskaDepartment of Obstetrics and Gynaecology, Institute of Mother and Child, Warsaw, Poland.ORCID http://orcid.org/0000-0001-8071-0368

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeLate-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.

methodsThis 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).

resultsThere 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.

conclusionsHome-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.

Indexed as

CardiotocographyFetal Growth RetardationUltrasonography, DopplerAdultApgar ScoreCesarean SectionFemaleHumansInfant, NewbornPilot ProjectsPregnancyRemote Patient MonitoringTelemedicineUmbilical ArteriesAnxiety disordersCardiotocographyFetal growth restrictionPlacental insufficiencyPregnancy complications

Identifiers

PMID42323763
PMCPMC13534194

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.