COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR: COSMOS Study
NCT ID: NCT05034861
Last Updated: 2022-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2022-12-13
2024-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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cCTG
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.
cCTG
Self-applied home computerized CTG device used twice weekly instead of standard Doppler assessment once weekly.
Doppler
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).
Doppler
Standard Doppler assessment provided once weekly in case of late FGR with positive end diastolic flow in the umbilical artery.
Interventions
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cCTG
Self-applied home computerized CTG device used twice weekly instead of standard Doppler assessment once weekly.
Doppler
Standard Doppler assessment provided once weekly in case of late FGR with positive end diastolic flow in the umbilical artery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Bielanski Hospital
OTHER
Institute of Mother and Child, Warsaw, Poland
OTHER
Responsible Party
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Urszula Nowacka
Principal Investigator
Principal Investigators
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Urszula Nowacka, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Mother and Child, Warsaw, Poland
Locations
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Institute of Mother and Child
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Anna Fijałkowska, Professor
Role: primary
References
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Lees CC, Stampalija T, Baschat A, da Silva Costa F, Ferrazzi E, Figueras F, Hecher K, Kingdom J, Poon LC, Salomon LJ, Unterscheider J. ISUOG Practice Guidelines: diagnosis and management of small-for-gestational-age fetus and fetal growth restriction. Ultrasound Obstet Gynecol. 2020 Aug;56(2):298-312. doi: 10.1002/uog.22134. No abstract available.
Nohuz E, Riviere O, Coste K, Vendittelli F. Prenatal identification of small-for-gestational age and risk of neonatal morbidity and stillbirth. Ultrasound Obstet Gynecol. 2020 May;55(5):621-628. doi: 10.1002/uog.20282. Epub 2020 Apr 6.
Ciobanu A, Khan N, Syngelaki A, Akolekar R, Nicolaides KH. Routine ultrasound at 32 vs 36 weeks' gestation: prediction of small-for-gestational-age neonates. Ultrasound Obstet Gynecol. 2019 Jun;53(6):761-768. doi: 10.1002/uog.20258. Epub 2019 Apr 30.
Figueras F, Gratacos E. Stage-based approach to the management of fetal growth restriction. Prenat Diagn. 2014 Jul;34(7):655-9. doi: 10.1002/pd.4412. Epub 2014 Jun 9.
Gordijn SJ, Beune IM, Thilaganathan B, Papageorghiou A, Baschat AA, Baker PN, Silver RM, Wynia K, Ganzevoort W. Consensus definition of fetal growth restriction: a Delphi procedure. Ultrasound Obstet Gynecol. 2016 Sep;48(3):333-9. doi: 10.1002/uog.15884.
Molina LCG, Odibo L, Zientara S, Obican SG, Rodriguez A, Stout M, Odibo AO. Validation of Delphi procedure consensus criteria for defining fetal growth restriction. Ultrasound Obstet Gynecol. 2020 Jul;56(1):61-66. doi: 10.1002/uog.20854. Epub 2020 Jun 7.
Baschat AA. Planning management and delivery of the growth-restricted fetus. Best Pract Res Clin Obstet Gynaecol. 2018 May;49:53-65. doi: 10.1016/j.bpobgyn.2018.02.009. Epub 2018 Mar 1.
Akolekar R, Ciobanu A, Zingler E, Syngelaki A, Nicolaides KH. Routine assessment of cerebroplacental ratio at 35-37 weeks' gestation in the prediction of adverse perinatal outcome. Am J Obstet Gynecol. 2019 Jul;221(1):65.e1-65.e18. doi: 10.1016/j.ajog.2019.03.002. Epub 2019 Mar 13.
Antenatal and postnatal mental health: clinical management and service guidance. London: National Institute for Health and Care Excellence (NICE); 2018 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK553127/
Lai J, Syngelaki A, Nicolaides KH, von Dadelszen P, Magee LA. Impact of new definitions of preeclampsia at term on identification of adverse maternal and perinatal outcomes. Am J Obstet Gynecol. 2021 May;224(5):518.e1-518.e11. doi: 10.1016/j.ajog.2020.11.004. Epub 2020 Nov 6.
Other Identifiers
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InstituteMCPoland
Identifier Type: -
Identifier Source: org_study_id