COmputerized CTG Self-MOnitoring Versus Standard Doppler Assessment in Late-onset FGR: COSMOS Study

NCT05034861 | Unknown

• 1 other identifier: InstituteMCPoland
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Fetal growth restriction is one of the major causes of perinatal morbidity, mortality and adverse neurological outcome. Growth restricted fetuses do not reach their potential due to multiple factors. Although early (\<32 weeks' gestation) FGR is associated with the highest risk of adverse outcomes, late FGR (≤ 32 weeks' gestation) is more common in daily maternal-fetal medicine care. Despite its' prevalence, optimal standard for monitoring differs between the centers and may be difficult in case of limited access to advanced perinatal care. We present a protocol for COmputerized CTG Self-MOnitoring versus Standard Doppler assessment in Late-onset FGR (COSMOS) trial, which is a prospective, cross-over, open-label and randomized trial that compares two different protocols for late-onset FGR observation. 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.

Conditions

Fetal Growth Restriction

Keywords

fetal growth restriction; fetal growth retardation; pregnancy; cardiotocography; ultrasound; Doppler; intrauterine growth restriction; maternal-fetal medicine; obstetrics

Outcome Measures

Primary Outcomes (9)

• Condition at birth

  Incidence of Apgar score at 5 min \<7 or arterial pH of \<7.0 or venous \<7.1 or resuscitation (compressions, medications, intubation)

  5 minutes after delivery

• Neonatal Intensive Care Unit admission

  Incidence any admission to the Neonatal Intensive Care Unit

  anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier

• Brain injury

  Incidence of Intraventricular haemorrhage (IVH) grade II or above-defined as bleeding into the ventricles; or hypoxic-ischaemic encephalopathy or periventricular leukomalacia or seizures recorded by EEG

  anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier

• Ventilation

  defined as need of positive pressure (continuous positive airway pressure (CPAP or nasal CPAP) or intubation rate

  anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier

• Respiratory distress syndrome

  defined as need of surfactant and ventilation as a result of prematurity

  anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier

• Cardiovascular support/treatment

  Incidence of anaemia-defined as low haemoglobin and/or haematocrit requiring blood transfusion or DIC - disseminated coagulopathy or ductus arteriosus treatment or hypotensive treatment

  anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier

• Neonatal sepsis

  Incidence of confirmed bacteraemia in cultures or necrotizing enterocolitis \- Necrotising enterocolitis (NEC)

  anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier

• Retinopathy

  incidence of retinopathy requiring laser or anti-VEGF administration

  anytime after the recruitment visit or after delivery before discharge from the hospital or up to 6 weeks after delivery if discharged earlier

• Fetal/neonatal death

  Rate of death in utero or after delivery before discharge from the hospital or up to 4 weeks after delivery if discharged earlier

  anytime after the recruitment visit or after delivery before discharge from the hospital or up to 4 weeks after delivery if discharged earlier

Secondary Outcomes (7)

• Maternal anxiety levels

  at the recruitment visit and every 2 weeks until delivery

• Compliance

  after the recruitment visit until delivery

• Number of hospital visits

  after the recruitment visit until delivery

• Mode of delivery

  through study completion, an average of 5 weeks after the recruitment visit

• Onset of labour

  through study completion, an average of 5 weeks after the recruitment visit

Study Arms (2)

cCTG

EXPERIMENTAL

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.

Device: cCTG

Doppler

ACTIVE COMPARATOR

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).

Diagnostic Test: Doppler

Interventions

cCTG DEVICE

Self-applied home computerized CTG device used twice weekly instead of standard Doppler assessment once weekly.

Also known as: Carebits device, www.carebits.pl

cCTG

Doppler DIAGNOSTIC_TEST

Standard Doppler assessment provided once weekly in case of late FGR with positive end diastolic flow in the umbilical artery.

Also known as: Doppler assessment

Doppler

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant individuals
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Mother and Child, Warsaw, Poland: lead
• Bielanski Hospital: collaborator

Study Sites (1)

Institute of Mother and Child

Warsaw, 01-211, Poland

RECRUITING

Related Publications (10)

• 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.

  PMID: 32738107 RESULT

• 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.

  PMID: 30950117 RESULT

• 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.

  PMID: 30883981 RESULT

• 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.

  PMID: 24839087 RESULT

• 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.

  PMID: 26909664 RESULT

• 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.

  PMID: 31520557 RESULT

• 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.

  PMID: 29606482 RESULT

• 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.

  PMID: 30878322 RESULT

• 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/

  PMID: 31990493 RESULT

• 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.

  PMID: 33166504 RESULT

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Echocardiography, Doppler

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Ultrasonography, Doppler; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Urszula Nowacka, MD

  Institute of Mother and Child, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Urszula Nowacka, MD

CONTACT

+48223277044; ulasarzynska@gmail.com; urszula.nowacka@imid.med.pl

Tadeusz Issat, Professor

CONTACT

+48223277044; tadeusz.issat@imid.med.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: September 5, 2021
• Study Start: December 13, 2022
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The deidentified participant data will become available upon publishing the protocol and results of the study. Study protocol will be available immediately following publication.
• Access Criteria: The data will be provided on request for anyone after methodologically sound proposal (contact details: urszula.nowacka@imid.med.pl).

Locations

PL (1)